A Phase 1 interventional study of Treatment A and Treatment B in HIV Infections, sponsored by ViiV Healthcare. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-09.
Sponsored by ViiV Healthcare (part of GlaxoSmithKline) · Phase 1, Interventional, and Treatment
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Among 265 studies in HIV Infections by GlaxoSmithKline — 14 open to participants now, 26 under way, 8 of them phase 3. HIV Infections · GlaxoSmithKline.
Among the 265 studies in HIV Infections by GlaxoSmithKline, this one is the 151st largest by enrollment of the 209 interventional ones that give a count, is one of 8 that started in 2018, is one of 82 in phase 1, and was the 188th registered.
4,736 studies on the registry are indexed under HIV Infections; 246 are open to participants now.
Browse HIV Infections studies →14 of the 265 studies in HIV Infections by GlaxoSmithKline are open now, in 12 countries. Recruiting first, the newest first:
ViiV Healthcare · Sites in United States
Ages 18–55 · Healthy volunteers
ViiV Healthcare · Sites in Romania, South Africa, Uganda
ViiV Healthcare · Sites in Netherlands
Ages 18–55 · Healthy volunteers
ViiV Healthcare · Sites in United States
Ages 18–55 · Healthy volunteers
ViiV Healthcare · Sites in South Africa
Ages up to 10 days · Healthy volunteers
By country, each count listing its studies:
Of the 159 HIV Infections studies recruiting now, 104 (65%) set no upper age limit and 42 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
265 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 84 · Phase 2 53 · Phase 3 68 · Phase 4 18
First in 1994; this study’s year is marked. 8 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 36 is below the median of 80 across 3,491 interventional studies indexed under HIV Infections.
Median enrollment 84 across the 209 interventional studies, 328 across the 14 observational. Of the 230 that completed or were terminated, 95 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under ViiV Healthcare, one of the names counted as GlaxoSmithKline. Under that name alone:
ViiV Healthcare is the lead sponsor of 266 studies on the registry; 17 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 53 (75%) have results posted.
5 of the studies in HIV Infections by GlaxoSmithKline that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07053384ViiV HealthcareA Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV | 2027-01-22 |
| NCT07934719ViiV HealthcareMass Balance and Absolute Bioavailability of [14C]-VH4011499 | 2027-02-18 |
| NCT06786520ViiV HealthcareA Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Cabotegravir Ultra Long-acting (CAB ULA) Following Switch From Cabotegravir Long-acting (CAB LA) in Healthy Adults | 2027-03-08 |
| NCT07525544ViiV HealthcareA Study to Investigate the Safety and PK of VH4770359 in Healthy Participants | 2027-05-05 |
| NCT07202546ViiV HealthcareA Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) | 2027-10-28 |
Add all 5 to your calendar (.ics) → With an account.
Among the 265 studies in HIV Infections by GlaxoSmithKline, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a 2-part, single-dose, open label, randomized 3-way cross-over study to compare BA of pediatric study drugs TRIUMEQ and (DTG/3TC) in healthy volunteers under fasted conditions. Study will be conducted in 2-parts. Each part 1 and part 2 will comprise of 3-treatment periods (TP) where Part 1, will assess BA, of pediatric TRIUMEQ dispersible tablets with an adult TRIUMEQ conventional tablet formulation and Part 2, will assess BA, of pediatric DTG/3TC dispersible tablets with adult DTG and 3TC conventional tablets formulation. Total duration of study is 9-weeks and will be conducted in approximately 36 subjects. The 2-parts, may be run in parallel as they are independent of each other. TRIUMEQ is a registered trademark of GlaxoSmithKline group of companies.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The subjects in Part 1 of the study, will receive a single dose of treatment A= adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) administered as direct-to-mouth, in TP1; treatment B=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) administered as a dispersion and taken immediately in TP2; and treatment C=Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) administered as direct-to-mouth in TP3. Each treatment will be followed by a wash-out period of 7-days minus 4 hours.
Drug: Treatment A · Drug: Treatment B · Drug: Treatment C
The subjects in Part 1 of the study, will receive treatment B in TP1, treatment C in TP2 and treatment A in TP3. Each treatment will be followed by a wash-out period of 7-days minus 4 hours.
Drug: Treatment A · Drug: Treatment B · Drug: Treatment C
The subjects in Part 1 of the study will receive a single dose each of, treatment C in TP1, treatment A in TP2 and treatment B in TP3. Each treatment will be followed by a wash-out period of 7-days minus 4 hours.
Drug: Treatment A · Drug: Treatment B · Drug: Treatment C
The subjects in Part 1 of the study will receive, treatment A in TP1, treatment C in TP2 and treatment B in TP3. Each treatment will be followed by a wash-out period of 7-days minus 4 hours.
Drug: Treatment A · Drug: Treatment B · Drug: Treatment C
The subjects in Part 1 of the study will receive a single dose each of, treatment B in TP1, treatment A in TP2 and treatment C in TP3. Each treatment will be followed by a wash-out period of 7-days minus 4 hours.
Drug: Treatment A · Drug: Treatment B · Drug: Treatment C
The subjects in Part 1 of the study will receive a single dose each of, treatment C in TP1, treatment B in TP2 and treatment A in TP3. Each treatment will be followed by a wash-out period of 7-days minus 4 hours.
Drug: Treatment A · Drug: Treatment B · Drug: Treatment C
The subjects in Part 2 of the study, will receive a single dose of treatment D= Adult DTG (50 mg, 1 conventional tablet) and adult 3TC (300 mg, 1 conventional tablet) administered as direct-to-mouth, in TP1; treatment E= Pediatric DTG/3TC (DTG 5 mg/3TC 30 mg, 10 dispersible tablets) administered as a dispersion and taken immediately in TP2; and treatment F= Pediatric DTG/3TC (DTG 5 mg/3TC 30 mg, 10 dispersible tablets) administered as direct-to-mouth in TP3. Each treatment will be followed by a wash-out period of 7-days minus 4 hours.
Drug: Treatment D · Drug: Treatment E · Drug: Treatment F
The subjects in Part 2 of the study, will receive a single dose respectively of treatment E in TP1, treatment F in TP2 and treatment D in TP3. Each treatment will be followed by a wash-out period of 7-days minus 4 hours.
Drug: Treatment D · Drug: Treatment E · Drug: Treatment F
The subjects in Part 2 of the study, will receive a single dose of treatment F in TP1, treatment D in TP2 and treatment E in TP3. Each treatment will be followed by a wash-out period of 7-days minus 4 hours.
Drug: Treatment D · Drug: Treatment E · Drug: Treatment F
The subjects in Part 2 of the study, will receive a single dose of treatment D in TP1, treatment F in TP2 and treatment E in TP3. Each treatment will be followed by a wash-out period of 7-days minus 4 hours.
Drug: Treatment D · Drug: Treatment E · Drug: Treatment F
The subjects in Part 2 of the study, will receive a single dose of treatment E in TP1, treatment D in TP2 and treatment F in TP3. Each treatment will be followed by a wash-out period of 7-days minus 4 hours.
Drug: Treatment D · Drug: Treatment E · Drug: Treatment F
The subjects in Part 2 of the study, will receive a single dose of treatment F in TP1, treatment E in TP2 and treatment D in TP3. Each treatment will be followed by a wash-out period of 7-days minus 4 hours.
Drug: Treatment D · Drug: Treatment F
TRIUMEQ (Adult) administered as a, single dose, fixed dose combination (FDC) tablet - DTG 50 mg/ABC 600 mg/3TC 300 mg as 1 conventional tablet, orally as direct-to-mouth.
TRIUMEQ (Pediatric) administered as a, single dose, FDC tablet - DTG 5 mg/ABC 60 mg/ 3TC 30 mg, orally as 10 dispersible tablets
TRIUMEQ (Pediatric) administered as a, single dose, FDC tablet - DTG 5 mg/ABC 60 mg/3TC 30 mg, orally as direct-to-mouth.
DTG and 3TC (Adult), administered as a, single dose, Single dose, 1 tablet DTG (50 mg) and 1 tablet 3TC (300 mg), orally as direct-to-mouth.
DTG and 3TC (Pediatric) administered as a, single dose, FDC tablet single dose, FDC tablet - DTG 5 mg/3TC 30 mg, orally as 10 dispersible tablets.
DTG and 3TC (Pediatric) administered as a, single dose, FDC tablet single dose, FDC tablet - DTG 5 mg/3TC 30 mg, orally as direct-to-mouth.
Area Under the Plasma Concentration-time Curve (AUC) From Time of Dose Extrapolated to Infinity (AUC[0-inf]) in Part 1 of DTG
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. PK population comprised of participants in the all participants population (participants who took at least 1 dose of study medication) for whom PK sample was obtained and who had evaluable PK assay results. Statistics has been presented on geometric least square (LS) means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
AUC From Time of Dose to Last Measurable Concentration (AUC[0-t]) in Part 1 of DTG
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose,15 and 30 minutes,1 ,1.5 ,2 ,2.5 ,3 ,4 ,5 ,6 ,8 ,12 ,16 ,24 ,48 and 72 hours post-dose of each treatment period
Maximum Observed Concentration (Cmax) in Part 1 of DTG in Plasma
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
AUC(0-inf) in Part 1 of ABC
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
AUC(0-t) in Part 1 of ABC
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Cmax in Part 1 of ABC in Plasma
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
AUC(0-inf) in Part 1 of 3TC
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
AUC (0-t) in Part 1 of 3TC
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Cmax in Part 1 of 3TC
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
AUC(0-inf) in Part 2 of DTG in Plasma
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
AUC(0-t) in Part 2 of DTG
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Cmax in Part 2 of DTG in Plasma
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
AUC(0-inf) in Part 2 of 3TC
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
AUC(0-t) in Part 2 of 3TC
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Cmax in Part 2 of 3TC
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
AUC From Time of Dose to 24 Hours (AUC[0-24]) of DTG in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period
Time to Maximum Concentration (Tmax) of DTG in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Time of Last Quantifiable Concentration (Tlast) of DTG in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Apparent Oral Clearance (CL/F) of DTG in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Apparent Volume of Distribution (Vz/F) of DTG in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Observed Concentration at 24 Hours Postdose (C24) of DTG in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period
Last Observed Quantifiable Concentration (Ct) of DTG in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Terminal Elimination Phase Half-life (t½) of DTG in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Lag Time for Absorption (Tlag) of DTG in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
AUC(0-24) of ABC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period
Tmax of ABC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Tlast of ABC in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
CL/F of ABC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Vz/F of ABC in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
C24 of ABC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period
Ct of ABC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
T½ of ABC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
AUC(0-24) of 3TC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period
Tmax of 3TC in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Tlast of 3TC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
CL/F of 3TC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Vz/F of 3TC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
C24 of 3TC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period
Ct of 3TC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
T½ of 3TC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
AUC (0-24) of DTG in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period
Tmax of DTG in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Tlast of DTG in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
CL/F of DTG in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Vz/F of DTG in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
C24 of DTG in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period
Ct of DTG in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
T½ of DTG in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Tlag of DTG in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
AUC (0-24) of 3TC in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period
Tmax of 3TC in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Tlast of 3TC in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
CL/F of 3TC in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Vz/F of 3TC in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
C24 of 3TC in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period
Ct of 3TC in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
T½ of 3TC in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) in Part 1
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety population comprised of all participants enrolled in the study, who took at least one dose of study treatment.
Time frame: Up to Day 33
Number of Participants With AEs and Serious Adverse Events SAEs in Part 2
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement.
Time frame: Up to Day 33
Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea
Blood samples were collected for the analysis of clinical chemistry parameters which included glucose, calcium, potassium, sodium and urea. All participants population included all participants who received at least one dose of study medication. This population corresponded to all participants enrolled.
Time frame: Day 2 of each treatment period
Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotranferase (AST) and Creatinine Phosphokinase (CPK)
Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK.
Time frame: Day 2 of each treatment period
Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein
Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein.
Time frame: Day 2 of each treatment period
Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin
Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin.
Time frame: Day 2 of each treatment period
Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea
Blood samples were collected for the analysis of clinical chemistry parameters including glucose, calcium, potassium, sodium and urea.
Time frame: Day 2 of each treatment period
Absolute Values for Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK
Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK.
Time frame: Day 2 of each treatment period
Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein
Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein.
Time frame: Day 2 of each treatment period
Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin
Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin.
Time frame: Day 2 of each treatment period
Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea
Blood samples were collected for the analysis of clinical chemistry parameters including glucose, calcium, potassium, sodium and urea. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: ALT, ALP, AST and CPK
Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein
Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin
Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea
Blood samples were collected for the analysis of clinical chemistry parameters including glucose, calcium, potassium, sodium and urea. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK
Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein
Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin
Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1
Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 1 at indicated time points.
Time frame: Day 2 of each treatment period
Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1
Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points.
Time frame: Day 2 of each treatment period
Absolute Values for Erythrocytes in Part 1
Blood samples were collected for the analysis erythrocytes in Part 1 at indicated time points.
Time frame: Day 2 of each treatment period
Absolute Values for Hemocrit in Part 1
Blood samples were collected for the analysis hemocrit in Part 1 at indicated time points.
Time frame: Day 2 of each treatment period
Absolute Values for Hemoglobin in Part 1
Blood samples were collected for the analysis hemoglobin in Part 1 at indicated time points.
Time frame: Day 2 of each treatment period
Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2
Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 2 at indicated time points.
Time frame: Day 2 of each treatment period
Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 2
Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points.
Time frame: Day 2 of each treatment period
Absolute Values for Erythrocyte Mean Corpuscular Volume in Part 2
Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points.
Time frame: Day 2 of each treatment period
Absolute Values for Erythrocytes in Part 2
Blood samples were collected for the analysis erythrocytes in Part 2 at indicated time points.
Time frame: Day 2 of each treatment period
Absolute Values for Hemocrit in Part 2
Blood samples were collected for the analysis hemocrit in Part 2 at indicated time points.
Time frame: Day 2 of each treatment period
Absolute Values for Hemoglobin in Part 2
Blood samples were collected for the analysis hemoglobin in Part 2 at indicated time points.
Time frame: Day 2 of each treatment period
Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1
Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Change From Baseline Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1
Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Change From Baseline Values for Erythrocyte Mean Corpuscular Volume in Part 1
Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Change From Baseline Values for Erythrocytes in Part 1
Blood samples were collected for the analysis erythrocytes in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Change From Baseline Values for Hemocrit in Part 1
Blood samples were collected for the analysis hemocrit in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Change From Baseline Values for Hemoglobin in Part 1
Blood samples were collected for the analysis hemoglobin in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2
Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Change From Baseline Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 2
Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Change From Baseline Values for Erythrocyte Mean Corpuscular Volume in Part 2
Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Change From Baseline Values for Erythrocytes in Part 2
Blood samples were collected for the analysis erythrocytes in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Change From Baseline Values for Hemocrit in Part 2
Blood samples were collected for the analysis hemocrit in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Change From Baseline Values for Hemoglobin in Part 2
Blood samples were collected for the analysis hemoglobin in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Number of Participants With Abnormal Urinalysis Parameter in Part 1
The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as increased, decreased, increase to trace, 1+ and 3+ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented.
Time frame: Up to Day 33
Number of Participants With Urine Potential of Hydrogen (pH)-Part 1
Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).
Time frame: Up to Day 33
Number of Participants With Abnormal Urinalysis Parameter in Part 2
The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as increased, decreased, increase to trace, 1+ and 3+ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented.
Time frame: Up to Day 33
Number of Participants With Urine Potential of Hydrogen (pH)-Part 2
Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).
Time frame: Up to Day 33
Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Part 1
Full 12-lead ECGs were recorded with the participant in a supine position. Absolute QTc Interval: \>450, absolute PR Interval: \<110 and Absolute QRS Interval: \<75 were considered to be potential clinically significant ECG finding. The number of participants with abnormal clinically significant ECG findings are presented.
Time frame: Baseline (Day -1)
Number of Participants With Abnormal ECG Findings in Part 2
Full 12-lead ECGs were recorded with the participant in a supine position. Absolute QTc Interval: \>450, absolute PR Interval: \<110 and Absolute QRS Interval: \<75 were considered to be potential clinically significant ECG finding. The number of participants with abnormal clinically significant ECG findings are presented
Time frame: Baseline (Day -1)
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Part 1
Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.
Time frame: Day 1 at 4 hours post intervention and Day 2 of each treatment period
Absolute Values for Pulse Rate in Part 1
Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest.
Time frame: Day 1 at 4 hours post intervention and Day 2 of each treatment period
Absolute Values for Temperature in Part 1
Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest.
Time frame: Day 1 at 4 hours post intervention dose and Day 2 of each treatment period
Absolute Values for SBP and DBP of Part 2
Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.
Time frame: Day 1 at 4 hours post intervention dose and Day 2 of each treatment period
Absolute Values for Pulse Rate in Part 2
Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest.
Time frame: Day 1 at 4 hours post intervention dose and Day 2 of each treatment period
Absolute Values for Temperature in Part 2
Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest.
Time frame: Day 1 at 4 hours post intervention dose and Day 2 of each treatment period
Change From Baseline in SBP and DBP of Part 1
Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2
Change From Baseline in Pulse Rate of Part 1
Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2
Change From Baseline in Temperature of Part 1
Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2
Change From Baseline in SBP and DBP of Part 2
Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2
Change From Baseline in Pulse Rate in Part 2
Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2
Change From Baseline in Temperature in Part 2
Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2
This was a 2-Part, Phase I, Single-Dose, 3-Period Crossover Relative Bioavailability Study of a Pediatric TRIUMEQ Dispersible Tablet and Pediatric Dolutegravir and Lamivudine (DTG/3TC) Fixed Dose Combination Dispersible Tablet Formulations as Compared with Adult Tablets in Healthy Participants.
| Milestone | Treatment Sequence ABC-Part 1 | Treatment Sequence BCA-Part 1 | Treatment Sequence CAB-Part 1 | Treatment Sequence ACB-Part 1 | Treatment Sequence BAC-Part 1 | Treatment Sequence CBA-Part 1 | Treatment DEF-Part 2 | Treatment EFD-Part 2 | Treatment FDE-Part 2 | Treatment DFE-Part 2 | Treatment EDF-Part 2 | Treatment FED-Part 2 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 3 | 3 | 3 | 3 | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 3 | 3 | 3 | 3 | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Treatment Sequence ABC-Part 1 | Treatment Sequence BCA-Part 1 | Treatment Sequence CAB-Part 1 | Treatment Sequence ACB-Part 1 | Treatment Sequence BAC-Part 1 | Treatment Sequence CBA-Part 1 | Treatment DEF-Part 2 | Treatment EFD-Part 2 | Treatment FDE-Part 2 | Treatment DFE-Part 2 | Treatment EDF-Part 2 | Treatment FED-Part 2 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 3 | 3 | 3 | 3 | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 3 | 3 | 3 | 3 | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Treatment Sequence ABC-Part 1 | Treatment Sequence BCA-Part 1 | Treatment Sequence CAB-Part 1 | Treatment Sequence ACB-Part 1 | Treatment Sequence BAC-Part 1 | Treatment Sequence CBA-Part 1 | Treatment DEF-Part 2 | Treatment EFD-Part 2 | Treatment FDE-Part 2 | Treatment DFE-Part 2 | Treatment EDF-Part 2 | Treatment FED-Part 2 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 3 | 3 | 3 | 3 | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 3 | 3 | 2 | 3 | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Positive urine drug screen lab value | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Treatment Sequence ABC-Part 1 | Treatment Sequence BCA-Part 1 | Treatment Sequence CAB-Part 1 | Treatment Sequence ACB-Part 1 | Treatment Sequence BAC-Part 1 | Treatment Sequence CBA-Part 1 | Treatment DEF-Part 2 | Treatment EFD-Part 2 | Treatment FDE-Part 2 | Treatment DFE-Part 2 | Treatment EDF-Part 2 | Treatment FED-Part 2 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 3 | 3 | 2 | 3 | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 3 | 3 | 2 | 3 | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Treatment Sequence ABC-Part 1 | Treatment Sequence BCA-Part 1 | Treatment Sequence CAB-Part 1 | Treatment Sequence ACB-Part 1 | Treatment Sequence BAC-Part 1 | Treatment Sequence CBA-Part 1 | Treatment DEF-Part 2 | Treatment EFD-Part 2 | Treatment FDE-Part 2 | Treatment DFE-Part 2 | Treatment EDF-Part 2 | Treatment FED-Part 2 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 3 | 3 | 2 | 3 | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 3 | 3 | 2 | 3 | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Treatment Sequence ABC-Part 1 | Treatment Sequence BCA-Part 1 | Treatment Sequence CAB-Part 1 | Treatment Sequence ACB-Part 1 | Treatment Sequence BAC-Part 1 | Treatment Sequence CBA-Part 1 | Treatment DEF-Part 2 | Treatment EFD-Part 2 | Treatment FDE-Part 2 | Treatment DFE-Part 2 | Treatment EDF-Part 2 | Treatment FED-Part 2 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | 3 | 3 | 3 | 3 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | 3 | 3 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Treatment Sequence ABC-Part 1 | Treatment Sequence BCA-Part 1 | Treatment Sequence CAB-Part 1 | Treatment Sequence ACB-Part 1 | Treatment Sequence BAC-Part 1 | Treatment Sequence CBA-Part 1 | Treatment DEF-Part 2 | Treatment EFD-Part 2 | Treatment FDE-Part 2 | Treatment DFE-Part 2 | Treatment EDF-Part 2 | Treatment FED-Part 2 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | 3 | 3 | 3 | 3 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | 3 | 3 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Treatment Sequence ABC-Part 1 | Treatment Sequence BCA-Part 1 | Treatment Sequence CAB-Part 1 | Treatment Sequence ACB-Part 1 | Treatment Sequence BAC-Part 1 | Treatment Sequence CBA-Part 1 | Treatment DEF-Part 2 | Treatment EFD-Part 2 | Treatment FDE-Part 2 | Treatment DFE-Part 2 | Treatment EDF-Part 2 | Treatment FED-Part 2 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | 3 | 3 | 3 | 3 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | 3 | 3 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Treatment Sequence ABC-Part 1 | Treatment Sequence BCA-Part 1 | Treatment Sequence CAB-Part 1 | Treatment Sequence ACB-Part 1 | Treatment Sequence BAC-Part 1 | Treatment Sequence CBA-Part 1 | Treatment DEF-Part 2 | Treatment EFD-Part 2 | Treatment FDE-Part 2 | Treatment DFE-Part 2 | Treatment EDF-Part 2 | Treatment FED-Part 2 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | 3 | 3 | 3 | 3 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | 3 | 3 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Treatment Sequence ABC-Part 1 | Treatment Sequence BCA-Part 1 | Treatment Sequence CAB-Part 1 | Treatment Sequence ACB-Part 1 | Treatment Sequence BAC-Part 1 | Treatment Sequence CBA-Part 1 | Treatment DEF-Part 2 | Treatment EFD-Part 2 | Treatment FDE-Part 2 | Treatment DFE-Part 2 | Treatment EDF-Part 2 | Treatment FED-Part 2 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | 3 | 3 | 3 | 3 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | 3 | 3 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. PK population comprised of participants in the all participants population (participants who took at least 1 dose of study medication) for whom PK sample was obtained and who had evaluable PK assay results. Statistics has been presented on geometric least square (LS) means.
| Hours*microgram per milliliter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Area Under the Plasma Concentration-time Curve (AUC) From Time of Dose Extrapolated to Infinity (AUC[0-inf]) in Part 1 of DTG | 59.761 ± 31 | 101.125 ± 22 | 77.742 ± 29 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
| Hours*microgram per milliliter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| AUC From Time of Dose to Last Measurable Concentration (AUC[0-t]) in Part 1 of DTG | 57.571 ± 29 | 97.746 ± 21 | 75.086 ± 28 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
| Micrograms per milliliter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Maximum Observed Concentration (Cmax) in Part 1 of DTG in Plasma | 3.093 ± 20 | 5.373 ± 15 | 4.134 ± 21 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
| Hours*microgram per milliliter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| AUC(0-inf) in Part 1 of ABC | 16.636 ± 21 | 17.321 ± 20 | 16.756 ± 22 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
| Hours*microgram per milliliter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| AUC(0-t) in Part 1 of ABC | 16.609 ± 21 | 17.298 ± 20 | 16.735 ± 22 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
| Micrograms per milliliter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Cmax in Part 1 of ABC in Plasma | 5.084 ± 19 | 5.351 ± 19 | 4.891 ± 23 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
| Hours*microgram per milliliter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| AUC(0-inf) in Part 1 of 3TC | 13.087 ± 26 | 13.062 ± 24 | 12.155 ± 30 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
| Hours*microgram per milliliter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| AUC (0-t) in Part 1 of 3TC | 12.857 ± 26 | 12.829 ± 24 | 11.893 ± 29 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means
| Micrograms per milliliter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Cmax in Part 1 of 3TC | 2.194 ± 29 | 2.053 ± 35 | 1.947 ± 34 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
| Hours*microgram per milliliter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| AUC(0-inf) in Part 2 of DTG in Plasma | 53.942 ± 38 | 88.676 ± 31 | 68.496 ± 32 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
| Hours*microgram per milliliter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| AUC(0-t) in Part 2 of DTG | 51.477 ± 38 | 85.340 ± 30 | 65.657 ± 31 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
| Micrograms per milliliter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Cmax in Part 2 of DTG in Plasma | 2.764 ± 44 | 5.461 ± 18 | 3.558 ± 28 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
| Hours*microgram per milliliter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| AUC(0-inf) in Part 2 of 3TC | 12.245 ± 17 | 12.149 ± 21 | 11.910 ± 20 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
| Hours*microgram per milliliter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| AUC(0-t) in Part 2 of 3TC | 11.991 ± 16 | 11.788 ± 20 | 11.633 ± 19 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
| Micrograms per milliliter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Cmax in Part 2 of 3TC | 2.276 ± 28 | 2.071 ± 27 | 2.093 ± 29 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Hours*microgram per milliliter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| AUC From Time of Dose to 24 Hours (AUC[0-24]) of DTG in Part 1 | 40.264 ± 23 | 69.745 ± 17 | 53.250 ± 22 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Hours | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Time to Maximum Concentration (Tmax) of DTG in Plasma in Part 1 | 3.00 (1.50 to 4.08) | 2.50 (1.00 to 6.00) | 3.00 (1.00 to 6.00) |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Hours | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Time of Last Quantifiable Concentration (Tlast) of DTG in Part 1 | 72.00 (72.00 to 72.00) | 72.00 (72.00 to 72.30) | 72.00 (72.00 to 72.02) |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Liters per hour | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Apparent Oral Clearance (CL/F) of DTG in Plasma in Part 1 | 0.8367 ± 31 | 0.4944 ± 22 | 0.6432 ± 29 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Liters | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Apparent Volume of Distribution (Vz/F) of DTG in Part 1 | 17.260 ± 20 | 10.074 ± 20 | 12.998 ± 21 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
| Nanograms per millilter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Observed Concentration at 24 Hours Postdose (C24) of DTG in Plasma in Part 1 | 925.303 ± 34 | 1523.534 ± 28 | 1198.948 ± 33 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Nanograms per milliliter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Last Observed Quantifiable Concentration (Ct) of DTG in Plasma in Part 1 | 84.968 ± 83 | 138.258 ± 65 | 106.140 ± 80 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Hours | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Terminal Elimination Phase Half-life (t½) of DTG in Plasma in Part 1 | 14.300 ± 21 | 14.123 ± 18 | 14.008 ± 20 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Hours | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Lag Time for Absorption (Tlag) of DTG in Part 1 | 0.00 (0.00 to 0.25) | 0.00 (0.00 to 0.00) | 0.00 (0.00 to 0.00) |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Hours*microgram per milliliter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| AUC(0-24) of ABC in Plasma in Part 1 | 16.619 ± 21 | 17.300 ± 20 | 16.743 ± 22 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Hours | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Tmax of ABC in Plasma in Part 1 | 1.50 (0.50 to 2.57) | 1.00 (0.25 to 2.00) | 1.00 (0.25 to 2.00) |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Hours | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Tlast of ABC in Part 1 | 24.00 (16.00 to 24.07) | 24.00 (16.00 to 24.12) | 24.00 (16.00 to 24.07) |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Liters per hour | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| CL/F of ABC in Plasma in Part 1 | 36.0658 ± 21 | 34.6391 ± 20 | 35.8073 ± 22 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Liters | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Vz/F of ABC in Part 1 | 120.412 ± 46 | 126.171 ± 39 | 123.076 ± 42 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
| Nanograms per millilter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| C24 of ABC in Plasma in Part 1 | 4.862 ± 45 | 4.491 ± 56 | 4.274 ± 26 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Nanograms per milliliter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Ct of ABC in Plasma in Part 1 | 6.852 ± 74 | 4.788 ± 58 | 5.466 ± 55 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Hours | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| T½ of ABC in Plasma in Part 1 | 2.314 ± 30 | 2.525 ± 26 | 2.382 ± 29 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Hours*microgram per milliliter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| AUC(0-24) of 3TC in Plasma in Part 1 | 11.968 ± 26 | 11.927 ± 26 | 10.952 ± 30 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Hours | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Tmax of 3TC in Part 1 | 2.50 (1.50 to 5.05) | 2.50 (1.00 to 4.00) | 2.50 (1.50 to 4.08) |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Hours | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Tlast of 3TC in Plasma in Part 1 | 72.00 (48.00 to 72.00) | 72.00 (48.00 to 72.30) | 72.00 (48.00 to 72.02) |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Liters per hour | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| CL/F of 3TC in Plasma in Part 1 | 22.9237 ± 26 | 22.9679 ± 24 | 24.6802 ± 30 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Liters | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Vz/F of 3TC in Plasma in Part 1 | 594.270 ± 31 | 591.102 ± 37 | 642.945 ± 38 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
| Nanograms per millilter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| C24 of 3TC in Plasma in Part 1 | 37.963 ± 29 | 40.913 ± 24 | 42.434 ± 27 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Nanograms per milliliter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Ct of 3TC in Plasma in Part 1 | 6.552 ± 62 | 6.798 ± 53 | 7.251 ± 64 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Hours | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| T½ of 3TC in Plasma in Part 1 | 17.969 ± 36 | 17.839 ± 35 | 18.057 ± 39 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Hours*microgram per milliliter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| AUC (0-24) of DTG in Plasma in Part 2 | 35.742 ± 39 | 61.220 ± 26 | 46.205 ± 29 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Hours | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Tmax of DTG in Plasma in Part 2 | 2.77 (0.50 to 5.00) | 0.77 (0.50 to 4.00) | 1.79 (0.50 to 5.00) |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Hours | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Tlast of DTG in Plasma in Part 2 | 72.00 (48.00 to 72.00) | 72.00 (72.00 to 72.05) | 72.00 (48.00 to 72.05) |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Liters per hour | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| CL/F of DTG in Plasma in Part 2 | 0.9269 ± 38 | 0.5639 ± 31 | 0.7300 ± 32 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Liters | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Vz/F of DTG in Plasma in Part 2 | 20.378 ± 42 | 11.950 ± 28 | 15.524 ± 30 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
| Nanograms per millilter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| C24 of DTG in Plasma in Part 2 | 825.313 ± 39 | 1289.044 ± 37 | 1034.078 ± 33 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Nanograms per milliliter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Ct of DTG in Plasma in Part 2 | 95.829 ± 47 | 131.216 ± 70 | 107.749 ± 64 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Hours | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| T½ of DTG in Plasma in Part 2 | 15.238 ± 21 | 14.690 ± 18 | 14.741 ± 23 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Hours | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Tlag of DTG in Plasma in Part 2 | 0.00 (0.00 to 0.25) | 0.00 (0.00 to 0.00) | 0.00 (0.00 to 0.00) |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Hours*microgram per milliliter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| AUC (0-24) of 3TC in Plasma in Part 2 | 11.070 ± 18 | 10.802 ± 21 | 10.673 ± 20 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Hours | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Tmax of 3TC in Plasma in Part 2 | 1.00 (0.50 to 3.03) | 1.50 (0.53 to 4.00) | 1.50 (1.00 to 4.00) |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Hours | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Tlast of 3TC in Plasma in Part 2 | 72.00 (72.00 to 72.00) | 72.00 (72.00 to 72.05) | 72.00 (72.00 to 72.05) |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Liters per hour | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| CL/F of 3TC in Plasma in Part 2 | 24.4998 ± 17 | 24.6933 ± 21 | 25.1888 ± 20 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Liters | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Vz/F of 3TC in Plasma in Part 2 | 730.859 ± 17 | 758.790 ± 28 | 711.280 ± 22 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
| Nanograms per millilter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| C24 of 3TC in Plasma in Part 2 | 35.808 ± 21 | 38.475 ± 18 | 38.336 ± 24 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Nanograms per milliliter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Ct of 3TC in Plasma in Part 2 | 7.735 ± 62 | 8.417 ± 67 | 7.480 ± 64 |
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
| Hours | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| T½ of 3TC in Plasma in Part 2 | 20.677 ± 22 | 21.299 ± 32 | 19.573 ± 24 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety population comprised of all participants enrolled in the study, who took at least one dose of study treatment.
| Participants | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Any AE | 1 | 1 | 2 |
| Any SAE | 0 | 0 | 0 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement.
| Participants | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Any AE | 1 | 0 | 1 |
| Any SAE | 0 | 0 | 0 |
Blood samples were collected for the analysis of clinical chemistry parameters which included glucose, calcium, potassium, sodium and urea. All participants population included all participants who received at least one dose of study medication. This population corresponded to all participants enrolled.
| Millimoles per liter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Glucose | 5.031 ± 0.3501 | 4.931 ± 0.3448 | 4.933 ± 0.3709 |
| Calcium | 2.377 ± 0.0577 | 2.371 ± 0.0775 | 2.384 ± 0.0704 |
| Potassium | 4.31 ± 0.269 | 4.26 ± 0.243 | 4.28 ± 0.271 |
| Sodium | 138.1 ± 2.19 | 138.2 ± 1.48 | 138.1 ± 1.55 |
| Urea | 4.096 ± 0.9369 | 4.293 ± 1.1218 | 4.203 ± 1.0572 |
Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK.
| International units per Liter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| ALT | 15.3 ± 7.20 | 14.8 ± 5.47 | 15.3 ± 5.80 |
| ALP | 54.4 ± 16.22 | 55.1 ± 16.89 | 54.4 ± 16.99 |
| AST | 16.1 ± 3.35 | 16.1 ± 3.51 | 15.9 ± 3.29 |
| CPK | 90.7 ± 57.16 | 81.9 ± 39.34 | 95.8 ± 52.83 |
Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein.
| Grams per liter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Albumin | 43.2 ± 2.82 | 42.9 ± 2.76 | 43.8 ± 2.58 |
| Protein | 70.7 ± 4.55 | 70.8 ± 4.59 | 71.9 ± 3.73 |
Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin.
| Micromoles per liter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Bilirubin | 9.58 ± 3.350 | 9.88 ± 3.612 | 9.99 ± 4.066 |
| Creatinine | 81.47 ± 14.774 | 82.73 ± 13.279 | 83.36 ± 13.647 |
| Direct bilirubin | 1.76 ± 0.469 | 1.88 ± 0.549 | 1.94 ± 0.609 |
Blood samples were collected for the analysis of clinical chemistry parameters including glucose, calcium, potassium, sodium and urea.
| Millimoles per liter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Glucose | 4.938 ± 0.2810 | 4.941 ± 0.3829 | 4.959 ± 0.3494 |
| Calcium | 2.378 ± 0.0833 | 2.367 ± 0.1066 | 2.366 ± 0.1098 |
| Potassium | 4.20 ± 0.252 | 4.10 ± 0.188 | 4.09 ± 0.240 |
| Sodium | 138.2 ± 1.50 | 138.3 ± 1.81 | 138.3 ± 1.56 |
| Urea | 4.603 ± 0.7878 | 4.343 ± 0.8311 | 4.398 ± 0.8430 |
Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK.
| International units per liter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| ALT | 16.1 ± 11.34 | 15.6 ± 8.25 | 14.9 ± 7.44 |
| ALP | 60.0 ± 18.87 | 58.8 ± 17.53 | 58.9 ± 17.72 |
| AST | 16.5 ± 5.93 | 15.6 ± 3.97 | 15.7 ± 4.96 |
| CPK | 90.9 ± 36.86 | 86.4 ± 33.82 | 81.7 ± 25.51 |
Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein.
| Grams per liter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Albumin | 43.9 ± 3.02 | 43.1 ± 4.09 | 43.1 ± 3.50 |
| Protein | 72.1 ± 3.79 | 70.9 ± 4.11 | 71.2 ± 5.26 |
Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin.
| Micromoles per liter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Bilirubin | 10.71 ± 2.872 | 10.60 ± 3.275 | 10.58 ± 2.869 |
| Creatinine | 87.66 ± 16.430 | 87.97 ± 14.906 | 87.11 ± 16.453 |
| Direct bilirubin | 2.14 ± 0.451 | 2.11 ± 0.514 | 2.12 ± 0.528 |
Blood samples were collected for the analysis of clinical chemistry parameters including glucose, calcium, potassium, sodium and urea. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
| Millimoles per liter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Glucose | 0.045 ± 0.4204 | -0.068 ± 0.3312 | -0.115 ± 0.3774 |
| Calcium | 0.023 ± 0.0701 | 0.026 ± 0.0696 | 0.026 ± 0.0535 |
| Potassium | 0.18 ± 0.256 | 0.17 ± 0.306 | 0.12 ± 0.411 |
| Sodium | -1.0 ± 1.73 | -1.0 ± 1.46 | -0.6 ± 1.34 |
| Urea | 0.361 ± 0.8156 | 0.386 ± 0.8436 | 0.027 ± 1.1490 |
Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
| International units per Liter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| ALT | -0.3 ± 1.69 | -0.1 ± 2.05 | -0.9 ± 1.51 |
| ALP | -2.6 ± 6.71 | -0.5 ± 2.81 | -0.2 ± 3.84 |
| AST | -1.4 ± 1.62 | -0.6 ± 1.58 | -1.6 ± 2.93 |
| CPK | -38.2 ± 65.11 | -25.1 ± 31.53 | -48.8 ± 83.77 |
Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
| Grams per liter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Albumin | 0.4 ± 2.06 | -0.3 ± 1.61 | 0.4 ± 1.94 |
| Protein | 1.9 ± 3.31 | 1.6 ± 3.12 | 2.1 ± 2.96 |
Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
| Micromoles per liter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Bilirubin | 1.95 ± 2.482 | 2.20 ± 2.313 | 1.63 ± 2.479 |
| Creatinine | 13.61 ± 5.090 | 13.06 ± 4.805 | 13.62 ± 3.782 |
| Direct bilirubin | 0.20 ± 0.409 | 0.30 ± 0.361 | 0.26 ± 0.455 |
Blood samples were collected for the analysis of clinical chemistry parameters including glucose, calcium, potassium, sodium and urea. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
| Millimoles per liter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Glucose | -0.128 ± 0.3363 | -0.107 ± 0.3500 | -0.175 ± 0.4178 |
| Calcium | 0.016 ± 0.0708 | 0.019 ± 0.0687 | -0.004 ± 0.0846 |
| Potassium | 0.06 ± 0.268 | -0.02 ± 0.411 | -0.11 ± 0.347 |
| Sodium | -0.7 ± 1.93 | -1.3 ± 1.78 | -0.6 ± 2.38 |
| Urea | 0.176 ± 1.0267 | 0.084 ± 1.1918 | 0.414 ± 0.8744 |
Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
| International units per liter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| ALT | -1.2 ± 3.26 | -2.0 ± 3.40 | -0.9 ± 2.85 |
| ALP | -1.7 ± 5.24 | -3.4 ± 6.06 | -0.7 ± 4.13 |
| AST | -2.1 ± 3.49 | -2.9 ± 3.61 | -2.2 ± 3.73 |
| CPK | -34.2 ± 38.44 | -40.3 ± 41.91 | -33.2 ± 30.98 |
Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
| Grams per liter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Albumin | -0.1 ± 2.15 | -0.1 ± 2.54 | -0.6 ± 2.45 |
| Protein | 1.1 ± 4.32 | 1.1 ± 4.30 | 0.6 ± 4.20 |
Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
| Micromoles per liter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Bilirubin | 1.84 ± 1.974 | 1.56 ± 2.848 | 1.91 ± 2.563 |
| Creatinine | 10.08 ± 7.023 | 10.32 ± 6.185 | 10.83 ± 6.796 |
| Direct bilirubin | 0.22 ± 0.352 | 0.20 ± 0.470 | 0.26 ± 0.434 |
Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 1 at indicated time points.
| 10^9 cells per liter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Basophils | 0.042 ± 0.0160 | 0.042 ± 0.0129 | 0.037 ± 0.0141 |
| Eosinophils | 0.152 ± 0.1202 | 0.145 ± 0.0996 | 0.144 ± 0.1151 |
| Lymphocytes | 1.709 ± 0.4699 | 1.639 ± 0.4326 | 1.672 ± 0.5362 |
| Monocytes | 0.448 ± 0.1305 | 0.436 ± 0.1550 | 0.432 ± 0.1002 |
| Neutrophils | 3.505 ± 1.2385 | 3.395 ± 1.5325 | 3.647 ± 1.2145 |
| Leukocytes | 5.86 ± 1.452 | 5.66 ± 1.670 | 5.93 ± 1.410 |
| Platelets | 248.8 ± 64.36 | 247.1 ± 59.94 | 258.5 ± 67.34 |
Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points.
| Picograms | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1 | 28.11 ± 2.625 | 27.98 ± 2.580 | 28.21 ± 2.585 |
Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points.
| Femtoliter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1 | 83.92 ± 5.899 | 83.84 ± 5.810 | 83.97 ± 5.683 |
Blood samples were collected for the analysis erythrocytes in Part 1 at indicated time points.
| 10^12 cells per liter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Absolute Values for Erythrocytes in Part 1 | 4.905 ± 0.4495 | 4.884 ± 0.4751 | 4.914 ± 0.4296 |
Blood samples were collected for the analysis hemocrit in Part 1 at indicated time points.
| Percentage of red blood cells in blood | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Absolute Values for Hemocrit in Part 1 | 0.4101 ± 0.03195 | 0.4076 ± 0.02824 | 0.4114 ± 0.03269 |
Blood samples were collected for the analysis hemoglobin in Part 1 at indicated time points.
| Grams per liter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Absolute Values for Hemoglobin in Part 1 | 137.2 ± 12.51 | 135.9 ± 11.13 | 138.1 ± 13.20 |
Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 2 at indicated time points.
| 10^9 cells per liter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Basophils | 0.042 ± 0.0186 | 0.044 ± 0.0253 | 0.039 ± 0.0171 |
| Eosinophils | 0.099 ± 0.0532 | 0.099 ± 0.0543 | 0.100 ± 0.0508 |
| Lymphocytes | 1.555 ± 0.4401 | 1.584 ± 0.5536 | 1.553 ± 0.4647 |
| Monocytes | 0.373 ± 0.1229 | 0.378 ± 0.1367 | 0.369 ± 0.1264 |
| Neutrophils | 2.940 ± 1.2394 | 2.885 ± 0.8698 | 2.931 ± 0.9070 |
| Leukocytes | 5.01 ± 1.513 | 4.98 ± 1.232 | 4.98 ± 1.240 |
| Platelets | 242.3 ± 57.86 | 240.6 ± 58.34 | 244.2 ± 57.67 |
Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points.
| Picograms | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 2 | 29.78 ± 1.582 | 29.79 ± 1.735 | 29.81 ± 1.673 |
Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points.
| Femtoliter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Absolute Values for Erythrocyte Mean Corpuscular Volume in Part 2 | 88.43 ± 3.869 | 88.28 ± 3.867 | 88.34 ± 4.251 |
Blood samples were collected for the analysis erythrocytes in Part 2 at indicated time points.
| 10^12 cells per liter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Absolute Values for Erythrocytes in Part 2 | 4.812 ± 0.4164 | 4.794 ± 0.4969 | 4.776 ± 0.4971 |
Blood samples were collected for the analysis hemocrit in Part 2 at indicated time points.
| Percentage of red blood cells in blood | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Absolute Values for Hemocrit in Part 2 | 0.4243 ± 0.02589 | 0.4219 ± 0.03425 | 0.4206 ± 0.03425 |
Blood samples were collected for the analysis hemoglobin in Part 2 at indicated time points.
| Grams per liter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Absolute Values for Hemoglobin in Part 2 | 143.0 ± 9.57 | 142.3 ± 11.33 | 141.8 ± 11.79 |
Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
| 10^9 cells per liter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Basophils | -0.009 ± 0.0176 | -0.009 ± 0.0162 | -0.011 ± 0.0100 |
| Eosinophils | -0.013 ± 0.0488 | -0.008 ± 0.0323 | -0.014 ± 0.0545 |
| Lymphocytes | -0.273 ± 0.4366 | -0.325 ± 0.4254 | -0.286 ± 0.2468 |
| Monocytes | -0.082 ± 0.1001 | -0.066 ± 0.1332 | -0.098 ± 0.0818 |
| Neutrophils | -0.008 ± 0.5373 | -0.202 ± 1.2690 | -0.088 ± 0.9868 |
| Leukocytes | -0.38 ± 0.640 | -0.61 ± 1.356 | -0.49 ± 0.964 |
| Platelets | 7.1 ± 12.27 | -2.8 ± 13.14 | 3.7 ± 12.15 |
Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
| Picograms | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Change From Baseline Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1 | 0.16 ± 0.394 | 0.18 ± 0.303 | 0.19 ± 0.367 |
Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
| Femtoliter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Change From Baseline Values for Erythrocyte Mean Corpuscular Volume in Part 1 | 0.09 ± 0.756 | 0.09 ± 0.634 | -0.01 ± 0.633 |
Blood samples were collected for the analysis erythrocytes in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
| 10^12 cells per liter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Change From Baseline Values for Erythrocytes in Part 1 | 0.191 ± 0.1562 | 0.121 ± 0.1513 | 0.221 ± 0.1443 |
Blood samples were collected for the analysis hemocrit in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
| Percentage of red blood cells in blood | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Change From Baseline Values for Hemocrit in Part 1 | 0.0164 ± 0.01412 | 0.0099 ± 0.01268 | 0.0188 ± 0.01373 |
Blood samples were collected for the analysis hemoglobin in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
| Grams per liter | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Change From Baseline Values for Hemoglobin in Part 1 | 6.1 ± 4.19 | 4.0 ± 4.46 | 7.2 ± 4.96 |
Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
| 10^9 cells per liter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Basophils | -0.004 ± 0.0134 | -0.004 ± 0.0142 | -0.008 ± 0.0142 |
| Eosinophils | 0.005 ± 0.0367 | -0.006 ± 0.0315 | 0.004 ± 0.0185 |
| Lymphocytes | -0.207 ± 0.2918 | -0.219 ± 0.2935 | -0.115 ± 0.2353 |
| Monocytes | -0.074 ± 0.0668 | -0.079 ± 0.0608 | -0.049 ± 0.0972 |
| Neutrophils | -0.602 ± 1.2902 | -0.497 ± 0.6402 | -0.487 ± 0.7496 |
| Leukocytes | -0.89 ± 1.333 | -0.81 ± 0.755 | -0.66 ± 0.811 |
| Platelets | -5.4 ± 22.31 | 0.3 ± 14.41 | -2.7 ± 17.91 |
Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
| Picograms | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Change From Baseline Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 2 | 0.16 ± 0.403 | 0.07 ± 0.353 | -0.04 ± 0.335 |
Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
| Femtoliter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Change From Baseline Values for Erythrocyte Mean Corpuscular Volume in Part 2 | 0.35 ± 0.678 | -0.01 ± 0.674 | 0.08 ± 0.666 |
Blood samples were collected for the analysis erythrocytes in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
| 10^12 cells per liter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Change From Baseline Values for Erythrocytes in Part 2 | 0.201 ± 0.2539 | 0.224 ± 0.2171 | 0.179 ± 0.1813 |
Blood samples were collected for the analysis hemocrit in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
| Percentage of red blood cells in blood | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Change From Baseline Values for Hemocrit in Part 2 | 0.0193 ± 0.02273 | 0.0195 ± 0.01974 | 0.0159 ± 0.01427 |
Blood samples were collected for the analysis hemoglobin in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
| Gram per liter | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Change From Baseline Values for Hemoglobin in Part 2 | 6.9 ± 7.70 | 6.8 ± 5.52 | 5.1 ± 5.63 |
The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as increased, decreased, increase to trace, 1+ and 3+ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented.
| Participants | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Glucose, No change/decrease | 17 | 17 | 18 |
| Glucose, Any increase | 0 | 0 | 0 |
| Ketones, No change/decrease | 17 | 16 | 17 |
| Ketones, Increase to trace | 0 | 1 | 1 |
| Occult blood, No change/decrease | 16 | 17 | 16 |
| Occult blood, Increase to trace | 0 | 0 | 0 |
| Occult blood, Increase to 1+ | 1 | 0 | 1 |
| Occult blood, Increase to 3+ | 0 | 0 | 1 |
| Protein, No change/decrease | 17 | 17 | 18 |
| Protein, Any increase | 0 | 0 | 0 |
Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).
| Participants | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| No change/decrease | 14 | 14 | 15 |
| Any increase | 3 | 3 | 3 |
| Increase to 5.5 | 1 | 0 | 1 |
| Increase to 6.0 | 0 | 0 | 0 |
| Increase to 6.5 | 1 | 1 | 1 |
| Increase to 7.0 | 1 | 2 | 0 |
| Increase to 7.5 | 0 | 0 | 0 |
| Increase to 8.0 | 0 | 0 | 1 |
The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as increased, decreased, increase to trace, 1+ and 3+ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented.
| Participants | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Glucose, No change/decrease | 18 | 18 | 18 |
| Glucose, Any increase | 0 | 0 | 0 |
| Ketones, No change/decrease | 17 | 18 | 18 |
| Ketones, Increase to trace | 1 | 0 | 0 |
| Occult blood, No change/decrease | 18 | 17 | 16 |
| Occult blood Any increase | 0 | 1 | 2 |
| Occult blood, Increase to trace | 0 | 0 | 1 |
| Occult blood, Increase to 1+ | 0 | 0 | 0 |
| Occult blood, Increase to 3+ | 0 | 1 | 1 |
| Protein, No change/decrease | 18 | 18 | 18 |
| Protein, Any increase | 0 | 0 | 0 |
Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).
| Participants | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| No change/decrease | 11 | 16 | 13 |
| Any increase | 7 | 2 | 5 |
| Increase to 5.5 | 0 | 0 | 0 |
| Increase to 6.0 | 1 | 0 | 1 |
| Increase to 6.5 | 0 | 0 | 2 |
| Increase to 7.0 | 4 | 2 | 2 |
| Increase to 7.5 | 2 | 0 | 0 |
| Increase to 8.0 | 0 | 0 | 0 |
Full 12-lead ECGs were recorded with the participant in a supine position. Absolute QTc Interval: \>450, absolute PR Interval: \<110 and Absolute QRS Interval: \<75 were considered to be potential clinically significant ECG finding. The number of participants with abnormal clinically significant ECG findings are presented.
| Participants | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Not clinically significant | 1 | 0 | 1 |
| Clinically significant | 0 | 0 | 0 |
Full 12-lead ECGs were recorded with the participant in a supine position. Absolute QTc Interval: \>450, absolute PR Interval: \<110 and Absolute QRS Interval: \<75 were considered to be potential clinically significant ECG finding. The number of participants with abnormal clinically significant ECG findings are presented
| Participants | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Not clinically significant | 1 | 1 | 2 |
| Clinically significant | 0 | 0 | 0 |
Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.
| Millimeters of mercury | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| SBP, Day 1- 4hours | 117.5 ± 12.25 | 120.7 ± 15.73 | 118.9 ± 10.05 |
| SBP, Day 2 | 114.0 ± 9.50 | 115.2 ± 11.27 | 115.7 ± 9.09 |
| DBP, Day 1- 4hours | 70.9 ± 10.88 | 74.0 ± 11.77 | 71.6 ± 8.71 |
| DBP, Day 2 | 68.1 ± 8.55 | 68.2 ± 7.49 | 68.3 ± 8.20 |
Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest.
| Beats per minute | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Day 1- 4hours | 59.5 ± 8.32 | 61.6 ± 12.02 | 59.7 ± 9.29 |
| Day 2 | 63.5 ± 8.21 | 66.6 ± 10.04 | 67.4 ± 9.60 |
Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest.
| Degree celsius | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Day 1- 4hours | 36.46 ± 0.433 | 36.44 ± 0.411 | 36.51 ± 0.362 |
| Day 2 | 36.41 ± 0.372 | 36.71 ± 0.347 | 36.66 ± 0.415 |
Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.
| Millimeters of mercury | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| SBP, Day 1- 4hours | 116.2 ± 7.38 | 118.9 ± 13.31 | 119.1 ± 13.73 |
| SBP, Day 2 | 116.0 ± 8.01 | 115.5 ± 9.20 | 113.2 ± 11.62 |
| DBP, Day 1-4 hours | 70.1 ± 9.38 | 70.9 ± 11.59 | 71.7 ± 11.02 |
| DBP, Day 2 | 69.5 ± 6.49 | 71.1 ± 9.62 | 69.9 ± 11.46 |
Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest.
| Beats per minute | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Day 1-4hours | 63.9 ± 14.95 | 62.6 ± 11.25 | 63.3 ± 13.64 |
| Day 2 | 67.7 ± 14.56 | 64.9 ± 12.36 | 66.5 ± 11.42 |
Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest.
| Degree celsius | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Day 1-4hours | 36.31 ± 0.381 | 36.28 ± 0.373 | 36.39 ± 0.429 |
| Day 2 | 36.33 ± 0.401 | 36.35 ± 0.228 | 36.45 ± 0.343 |
Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
| Millimeters of mercury | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| SBP, Day 1- 4hours | 0.1 ± 9.90 | 3.9 ± 10.59 | 3.1 ± 8.54 |
| SBP, Day 2 | -3.4 ± 5.94 | -1.6 ± 7.33 | -0.2 ± 7.74 |
| DBP, Day 1- 4hours | -3.2 ± 9.36 | 4.6 ± 8.08 | 1.3 ± 6.51 |
| DBP, Day 2 | -6.1 ± 5.21 | -1.2 ± 5.23 | -1.9 ± 4.89 |
Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
| Beats per minute | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Day 1- 4hours | -5.5 ± 7.31 | -4.4 ± 5.91 | -7.8 ± 8.47 |
| Day 2 | -1.5 ± 5.97 | 0.5 ± 7.37 | -0.1 ± 8.79 |
Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
| Degree celsius | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Day 1- 4hours | 0.14 ± 0.550 | 0.02 ± 0.256 | 0.21 ± 0.454 |
| Day 2 | 0.09 ± 0.365 | 0.28 ± 0.251 | 0.36 ± 0.412 |
Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
| Millimeters of mercury | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| SBP, Day 1- 4hours | -4.4 ± 7.66 | 0.9 ± 14.51 | -2.4 ± 8.63 |
| SBP, Day 2 | -4.6 ± 11.43 | -2.5 ± 11.95 | -8.3 ± 9.86 |
| DBP, Day 1-4 hours | -0.9 ± 5.79 | 0.5 ± 7.73 | -0.5 ± 7.82 |
| DBP, Day 2 | -1.5 ± 6.69 | 0.7 ± 6.86 | -2.2 ± 7.77 |
Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
| Beats per minute | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Day 1-4hours | -4.7 ± 7.54 | -5.7 ± 9.38 | -8.6 ± 13.61 |
| Day 2 | -0.9 ± 7.76 | -3.3 ± 9.98 | -5.4 ± 14.18 |
Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
| Degree celsius | DTG 50 mg/3TC 300 mg Tablet | DTG 5 mg/3TC 30 mg Dispersible Tablet | DTG 5 mg/3TC 30mg Dispersible Tablet Direct to Mouth |
|---|---|---|---|
| Day 1-4hours | -0.01 ± 0.508 | 0.05 ± 0.660 | -0.02 ± 0.514 |
| Day 2 | 0.02 ± 0.522 | 0.12 ± 0.565 | 0.03 ± 0.469 |
Collected over The SAEs and AEs were collected from Day 1 up to Day 33.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet-Part 1 | 0/17 (0%) | 0/17 (0%) | 1/17 (5.9%) |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets-Part 1 | 0/17 (0%) | 0/17 (0%) | 1/17 (5.9%) |
| DTG5mg/ABC60mg/3TC30mgdispersible Tablet Direct to Mouth-Part1 | 0/18 (0%) | 0/18 (0%) | 2/18 (11.1%) |
| DTG 50 mg/3TC 300 mg Tablet-Part 2 | 0/18 (0%) | 0/18 (0%) | 1/18 (5.6%) |
| DTG 5 mg/3TC 30 mg Dispersible Tablet-Part 2 | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth-Part 2 | 0/18 (0%) | 0/18 (0%) | 1/18 (5.6%) |
| Event | DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet-Part 1 | DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets-Part 1 | DTG5mg/ABC60mg/3TC30mgdispersible Tablet Direct to Mouth-Part1 | DTG 50 mg/3TC 300 mg Tablet-Part 2 | DTG 5 mg/3TC 30 mg Dispersible Tablet-Part 2 | DTG 5 mg/3TC 30 mg Dispersible Tablet Direct to Mouth-Part 2 |
|---|---|---|---|---|---|---|
| Vessel puncture site reactionGeneral disorders | 0/17 | 0/17 | 2/18 | 0/18 | 0/18 | 0/18 |
| NauseaGastrointestinal disorders | 1/17 | 0/17 | 0/18 | 0/18 | 0/18 | 0/18 |
| Urinary tract infectionInfections and infestations | 0/17 | 1/17 | 0/18 | 0/18 | 0/18 | 0/18 |
| Vessel puncture site erythemaGeneral disorders | 0/17 | 0/17 | 1/18 | 0/18 | 0/18 | 0/18 |
| Vessel puncture site painGeneral disorders | 0/17 | 0/17 | 0/18 | 0/18 | 0/18 | 1/18 |
| PresyncopeNervous system disorders | 0/17 | 0/17 | 0/18 | 1/18 | 0/18 | 0/18 |
| Age, Continuous(Years) | All Study Participants in Part 1 | All Study Participants in Part 2 | Total |
|---|---|---|---|
| Mean | 34.9 ± 10.08 | 33.9 ± 8.47 | 34.4 ± 9.19 |
| Sex: Female, Male(Participants) | All Study Participants in Part 1 | All Study Participants in Part 2 | Total |
|---|---|---|---|
| Female | 9 | 5 | 14 |
| Male | 9 | 13 | 22 |
| Race/Ethnicity, Customized(Participants) | All Study Participants in Part 1 | All Study Participants in Part 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian-Central/South Asian Heritage | 0 | 0 | 0 |
| Asian-Japanese/East/South-East Asian Heritage | 0 | 4 | 4 |
| Black or African American | 5 | 6 | 11 |
| Native Hawaiian or other Pacific Islander | 1 | 0 | 1 |
| White | 12 | 8 | 20 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available, within 6 months of publishing the results of the primary endpoints of the study.
Access criteria: Access is provided, after a research proposal is submitted and has submitted approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided, for an initial period of 12 months but an extension can be granted, when justified for up to another 12 months.
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from Feb 2018 to primary completion in Apr 2018, 2 months.
Results were first posted in Dec 2019, 1 year 7 months after primary completion.
Of 74 industry-sponsored phase 1 interventional studies under HIV Infections, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 18. This study's 2 months is below that.
Counting every sponsor, half of 165 studies reached it within 19 months; a quarter within 7 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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