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CompletedNCT03836729Updated Apr 21, 2020Results posted

Study to Evaluate the Effect of GSK3640254 on the Pharmacokinetics of Tenofovir Alafenamide/Emtricitabine

A Phase 1 interventional study of Tenofovir alafenamide/emtricitabine and GSK3640254 in HIV Infections, sponsored by ViiV Healthcare. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-21.

Sponsored by ViiV Healthcare · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Ages
18 Years to 55 Years
Sex
All
01

Study summary

Human immunodeficiency virus (HIV) infection frequently involves combination drug therapy for its treatment; hence, it is important to understand their interactions and resulting changes in exposure which are associated with medications. This is a Phase-1, open-label, fixed-sequence 2-period, one-way drug interaction study to assess the pharmacokinetic (PK), safety, and tolerability of GSK3640254 and Tenofovir alafenamide/emtricitabine (TAF/FTC) when administered alone and in combination in healthy subjects. The study will consist of a screening period of 28 days before the first dose of study intervention followed by 2 sequential treatment periods. Subjects will be administered TAF/FTC 25/200 milligram (mg) once daily (QD) on Days 1 to 14 of Period 1 followed by co-administration of TAF/FTC 25/200 mg QD with GSK3640254 200 mg QD on Days 1 to 7 of Period 2.

02

Conditions studied

  • HIV Infections

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Keywords

  • Human immunodeficiency virus
  • Sequential
  • Tenofovir alafenamide
  • Emtricitabine
  • GSK3640254
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 16 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

ViiV Healthcare is the lead sponsor of 261 studies on the registry; 16 are open to participants now.

Of its 66 completed or terminated interventional studies of FDA-regulated products, 50 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subject must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
  • Subjects who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).
  • Body weight >=50.0 kilograms (kg) (110 pound [lbs]) for men and >=45.0 kilograms [kg] (99 lbs) for women and body mass index (BMI) within the range 18.5 to 31.0 kilograms per meter square (kg/m\^2) (inclusive).
  • Male or female; A female subject is eligible to participate if she is not pregnant, not breastfeeding and not a woman of childbearing potential (WOCBP).
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol.

Exclusion criteria

Exclusion Criteria:

  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • A pre-existing condition interfering with normal gastrointestinal (GI) anatomy or motility (e.g.,gastroesophageal reflux disease, gastric ulcers, gastritis), hepatic and/or renal function, that could interfere with the absorption, metabolism and/or excretion of the study drugs or render the subject unable to take oral study intervention.
  • Any history of significant underlying psychiatric disorder including, but not limited to, schizophrenia, bipolar disorder with or without psychotic symptoms, other psychotic disorders, or schizotypal (personality) disorder.
  • Any history of major depressive disorder with or without suicidal features or anxiety disorders, that required medical intervention (pharmacologic or not) such as hospitalization or other inpatient treatment and/or chronic (>6 months) outpatient treatment. Subjects with other conditions such as adjustment disorder or dysthymia that have required shorter term medical therapy (\<6 months) without inpatient treatment and are currently well-controlled clinically or resolved may be considered for entry after discussion and agreement with the ViiV Medical Monitor.
  • Any pre-existing physical or other psychiatric condition (including alcohol or drug abuse), which, in the opinion of the investigator (with or without psychiatric evaluation), could interfere with the subject's ability to comply with the dosing schedule and protocol evaluations or which might compromise the safety of the subject.
  • Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome.
  • History of any kidney disease or current or chronic history of impaired renal function as indicated by an estimated creatinine clearance \<80 milliliters per minute (mL/min). Creatinine clearance (CrCL) is estimated by either of the following methods: (a) The Modification of Diet in Renal Disease (MDRD) equation: estimated glomerular filtration rate (eGFR) (milliliter [mL]/minute [min]/1.73 meter square [m\^2]) = 175 x (SCr)\^-1.154 x (Age)\^-0.203 x 0.742 [if female] x 1.212 [if African American] glomerular filtration rate (GFR) is expressed in mL/min/1.73 m\^2, SCr is serum creatinine expressed in milligrams per deciliter (mg/dL), and age is expressed in years. (b)The Cockcroft-Gault equation: CrCL(mL/min) ={((l40-age) x weight)/(72xSCr)}x 0.85 (if female) CrCL is expressed in mL/min, age is expressed in years, weight is expressed in kg, and SCr is serum creatinine expressed in mg/dL.
  • Presence of Hepatitis B surface antigen (HBsAg) at Screening or within 3 months prior to starting study intervention.
  • Positive Hepatitis C antibody test result at Screening or within 3 months prior to starting study intervention AND positive on reflex to Hepatitis C ribonucleic acid (RNA).
  • Positive HIV-1 and -2 antigen/antibody immunoassay at Screening.
  • ALT >1.5 × upper limit of normal (ULN). A single repeat of ALT is allowed within a single screening period to determine eligibility.
  • Bilirubin >1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
  • Any acute laboratory abnormality at Screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound.
  • Any Grade 2 to 4 laboratory abnormality at Screening, with the exception of creatine phosphokinase (CPK) and lipid abnormalities (e.g., total cholesterol, triglycerides, etc), and ALT (described above), will exclude a subject from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the sponsor. A single repeat of any laboratory abnormality is allowed within a single screening period to determine eligibility.
  • A positive test result for drugs of abuse (including marijuana), alcohol, or cotinine (indicating active current smoking) at Screening or before the first dose of study intervention.
  • Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication and for the duration of the study.
  • Treatment with any vaccine within 30 days prior to receiving study intervention.
  • Unwillingness to abstain from excessive consumption of any food or drink containing grapefruit and grapefruit juice, Seville oranges, blood oranges, or pomelos or their fruit juices within 7 days prior to the first dose of study intervention(s) until the end of the study.
  • Participation in another concurrent clinical study or prior clinical study (with the exception of imaging trials) prior to the first dosing day in the current study: 30 days, 5 half-lives, or twice the duration of the biological effect of the study intervention (whichever is longer).
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 56 days.
  • Any positive (abnormal) response confirmed by the investigator on a screening clinician- or qualified designee-administered Columbia-Suicide Severity Rating Scale (C-SSRS).
  • Any significant arrhythmia or ECG finding (e.g., prior myocardial infarction, sinoatrial pauses, bundle branch block, or conduction abnormality) which, in the opinion of the investigator or VH/GSK Medical Monitor, will interfere with the safety for the individual subject.
  • Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination): Heart rate for male: \<45 or >100 beats per minute (bpm) and for females: \<50 or >100 bpm; PR interval: \<120 or >200 milliseconds (msec); QRS duration: \<70 or >110 msec and QTcF interval for male: >450 msec and for female: >470 msec. A heart rate from 100 to 110 bpm can be rechecked by ECG or vital signs within 30 minutes to verify eligibility.
  • History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 units. One unit is equivalent to 8 grams of alcohol: a half-pint (equivalent to 240 mL) of beer, 1 glass (125 mL) of wine, or 1 (25 mL) measure of spirits.
  • Regular use of tobacco- or nicotine-containing products within 3 months prior to Screening.
  • History of sensitivity to any of the study medications or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    TAF/FTC followed by TAF/FTC + GSK3640254

    Subjects will receive TAF/FTC 25/200 mg QD on Days 1 through 14 in Treatment Period 1. Subjects will be co-administered TAF/FTC 25/200 mg QD with GSK3640254 200 mg QD on Days 1 through 7 in Treatment Period 2.

    Drug: Tenofovir alafenamide/emtricitabine · Drug: GSK3640254

Interventions

  • DrugTenofovir alafenamide/emtricitabine

    TAF/FTC will be available as 25/200 milligrams (mg) tablet. Subjects will be administered TAF/FTC 25/200 mg QD via the oral route.

  • DrugGSK3640254

    GSK3640254 will be available as 100 mg capsule. Subjects will be administered GSK3640254 200 mg capsule QD via the oral route.

06

What researchers measure

Primary outcomes

  1. Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing Interval at Steady State (AUC [0-tau]) of TAF

    Blood samples were collected at indicated time-points for analysis of AUC (0-tau). Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. PK Parameter Population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated.

    Time frame: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

  2. Period 2: AUC (0-tau) of TAF

    Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

  3. Period 1: Maximum Observed Concentration (Cmax) of TAF

    Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

  4. Period 2: Cmax of TAF

    Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

  5. Period 1: AUC (0-tau) of FTC

    Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

  6. Period 2: AUC (0-tau) of FTC

    Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

  7. Period 1:Cmax of FTC

    Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

  8. Period 2:Cmax of FTC

    Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

  9. Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of FTC

    Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

  10. Period 2: Ctau of FTC

    Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

  11. Period 1: AUC (0-tau) of Tenofovir (TFV)

    Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

  12. Period 2: AUC (0-tau) of TFV

    Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

  13. Period 1: Cmax of TFV

    Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

  14. Period 2: Cmax of TFV

    Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

  15. Period 1: Ctau of TFV

    Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

  16. Period 2: Ctau of TFV

    Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

Secondary outcomes

  1. Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE)

    An adverse events (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An 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; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before

    Time frame: Up to Day 24

  2. Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils

    Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 7, and 14

  3. Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils

    Blood samples were collected at indicated timepoints for analysis for hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 3, 7, 9

  4. Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils

    Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Day -1 for Period 1.

    Time frame: Baseline and at Days 7, and 14

  5. Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils

    Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Period 1 Day 14 for Period 2.

    Time frame: Baseline and at Days 3, 7, 9

  6. Period 1: Change From Baseline in Hematology Parameter of Hematocrit

    Blood samples were collected at indicated timepoints for analysis of hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 7, 14

  7. Period 2: Change From Baseline in Hematology Parameter of Hematocrit

    Blood samples were collected at indicated time-points for analysis for hematology parameter like hematocrit. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 3, 7, 9

  8. Period 1: Absolute Values of the Hematology Parameter: Hematocrit

    Blood samples were collected at indicated time points for analysis for hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1.

    Time frame: Baseline and at Days 7, 14

  9. Period 2: Absolute Values of the Hematology Parameter: Hematocrit

    Blood samples were collected at indicated time-points for analysis for hematology parameter like hematocrit. Baseline was defined as Period 1 Day 14 for Period 2.

    Time frame: Baseline and at Days 3, 7, 9

  10. Period 1: Change From Baseline in Hematology Parameter of Hemoglobin

    Blood samples were collected at indicated timepoints for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 7, 14

  11. Period 2: Change From Baseline in Hematology Parameter of Hemoglobin

    Blood samples were collected at indicated timepoints for analysis of hematology parameter like hemoglobin. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 3, 7, 9

  12. Period 1: Absolute Values of the Hematology Parameter: Hemoglobin

    Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1.

    Time frame: Baseline and at Days 7, 14

  13. Period 2: Absolute Values of the Hematology Parameter: Hemoglobin

    Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Period 1 Day 14 for Period 2.

    Time frame: Baseline and at Days 3, 7, 9

  14. Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH)

    Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCH. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 7, 14

  15. Period 2: Change From Baseline in Hematology Parameter of MCH

    Blood samples were collected at indicated timepoints for analysis for hematology parameter like MCH. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 3, 7, 9

  16. Period 1: Absolute Values of the Hematology Parameter: MCH

    Blood samples were collected at indicated time-points for analysis for hematology parameter like MCH. Baseline was defined as Day -1 for Period 1.

    Time frame: Baseline and at Days 7, 14

  17. Period 2: Absolute Values of the Hematology Parameter: MCH

    Blood samples were collected at indicated time-points for analysis of hematology parameter like MCH. Baseline was defined as Period 1 Day 14 for Period 2.

    Time frame: Baseline and at Days 3, 7, 9

  18. Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV)

    Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 7, 14

  19. Period 2: Change From Baseline in Hematology Parameter of MCV

    Blood samples were collected at indicated timepoints for analysis for hematology parameter like MCV. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 3, 7, 9

  20. Period 1: Absolute Values of the Hematology Parameter: MCV

    Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1.

    Time frame: Baseline and at Days 7, 14

  21. Period 2: Absolute Values of the Hematology Parameter: MCV

    Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Period 1 Day 14 for Period 2.

    Time frame: Baseline and at Days 3, 7, 9

  22. Period 1: Change From Baseline in Hematology Parameter of Erythrocytes

    Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 7, 14

  23. Period 2: Change From Baseline in Hematology Parameter of Erythrocytes

    Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 3, 7, 9

  24. Period 1: Absolute Values of the Hematology Parameter: Erythrocytes

    Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1.

    Time frame: Baseline and at Days 7, 14

  25. Period 2: Absolute Values of the Hematology Parameter: Erythrocytes

    Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Period 1 Day 14 for Period 2.

    Time frame: Baseline and at Days 3, 7, 9

  26. Period 1: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), Carbon Dioxide (CO2), Chloride and Phosphorus

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 7, 14

  27. Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 3, 7, 9

  28. Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus

    Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Day -1 for Period 1.

    Time frame: Baseline and at Days 7, 14

  29. Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Period 1 Day 14 for Period 2.

    Time frame: Baseline and at Days 3, 7, 9

  30. Period 1: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH), Gamma-glutamyl Transferase (GGT), and Creatine Phosphokinase (CK)

    Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter like alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 7, 14

  31. Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 3, 7, 9

  32. Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Day -1 for Period 1.

    Time frame: Baseline and at Days 7, 14

  33. Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Period 1 Day 14 for Period 2.

    Time frame: Baseline and at Days 3, 7, 9

  34. Period 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 7, 14

  35. Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 3, 7, 9

  36. Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Day -1 for Period 1.

    Time frame: Baseline and at Days 7, 14

  37. Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Period 1 Day 14 for Period 2.

    Time frame: Baseline and at Days 3, 7, 9

  38. Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 7, 14

  39. Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 3, 7, 9

  40. Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Day -1 for Period 1.

    Time frame: Baseline and at Days 7, 14

  41. Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, creatinine and uric acid. Baseline was defined as Period 1 Day 14 for Period 2.

    Time frame: Baseline and at Days 3, 7, 9

  42. Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of of total protein, albumin and globulin. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 7, 14

  43. Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total protein, albumin and globulin. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 3, 7, 9

  44. Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total protein, albumin and globulin. Baseline was defined as Day -1 for Period 1.

    Time frame: Baseline and at Days 7, 14

  45. Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, creatinine and uric acid. Baseline was defined as Period 1 Day 14 for Period 2.

    Time frame: Baseline and at Days 3, 7, 9

  46. Period 1: Change From Baseline in Specific Gravity of Urine

    Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 7, 14

  47. Period 2: Change From Baseline in Specific Gravity of Urine

    Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 3, 7, 9

  48. Period 1: Absolute Values of Specific Gravity of Urine

    Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Day -1 for Period 1.

    Time frame: Baseline and at Days 7, 14

  49. Period 2: Absolute Values of Specific Gravity of Urine

    Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Period 1 Day 14 for Period 2.

    Time frame: Baseline and at Days 3, 7, 9

  50. Period 1: Change From Baseline in Potential of Hydrogen (pH) of Urine

    Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 7, 14

  51. Period 2: Change From Baseline in pH of Urine

    Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 3, 7, 9

  52. Period 1: Absolute Values of pH of Urine

    Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Day -1 for Period 1.

    Time frame: Baseline and at Days 7, 14

  53. Period 2: Absolute Values of pH of Urine

    Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Period 1 Day 14 for Period 2.

    Time frame: Baseline and at Days 3, 7, 9

  54. Period 1: Change From Baseline in Urine Urobilinogen

    Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 7, 14

  55. Period 2: Change From Baseline in Urine Urobilinogen

    Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 3, 7, 9

  56. Period 1: Absolute Values of Urine Urobilinogen

    Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1.

    Time frame: Baseline and at Days 7, 14

  57. Period 2: Absolute Values of Urine Urobilinogen

    Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Period 1 Day 14 for Period 2.

    Time frame: Baseline and at Days 3, 7, 9

  58. Period 1: Change From Baseline in Heart Rate

    Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Day 1, 2 and 4 hours post-dose

  59. Period 2: Change From Baseline in Heart Rate

    Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose

  60. Period 1: Absolute Values of Heart Rate

    Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Day 1, 2 and 4 hours post-dose

  61. Period 2: Absolute Values of Heart Rate

    Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period.

    Time frame: Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose

  62. Period 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval

    Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interal, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Day 1, 2 and 4 hours post-dose

  63. Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval

    Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interal, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose

  64. Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval

    Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period.

    Time frame: Baseline and at Day 1, 2 and 4 hours post-dose

  65. Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval

    Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period.

    Time frame: Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose

  66. Period 1: Change From Baseline in Temperature

    Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 2, 3, 4, 5 and 7

  67. Period 2: Change From Baseline in Temperature

    Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 4, 7, 9, and 10

  68. Period 1: Absolute Values of Temperature

    Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.

    Time frame: Baseline and at Days 2, 3, 4, 5 and 7

  69. Period 2: Absolute Values of Temperature

    Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.

    Time frame: Baseline and at Days 4, 7, 9, and 10

  70. Period 1: Change From Baseline in Pulse Rate

    Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 2, 3, 4, 5 and 7

  71. Period 2: Change From Baseline in Pulse Rate

    Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 4, 7, 9, and 10

  72. Period 1: Absolute Values of Pulse Rate

    Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.

    Time frame: Baseline and at Days 2, 3, 4, 5 and 7

  73. Period 2: Absolute Values of Pulse Rate

    Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.

    Time frame: Baseline and at Days 4, 7, 9, and 10

  74. Period 1: Change From Baseline in Respiratory Rate

    Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 2, 3, 4, 5 and 7

  75. Period 2: Change From Baseline in Respiratory Rate

    Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 4, 7, 9, and 10

  76. Period 1: Absolute Values of Respiratory Rate

    Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.

    Time frame: Baseline and at Days 2, 3, 4, 5 and 7

  77. Period 2: Absolute Values of Respiratory Rate

    Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.

    Time frame: Baseline and at Days 4, 7, 9, and 10

  78. Period 1: Change From Baseline in Blood Pressure

    Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 2, 3, 4, 5 and 7

  79. Period 2: Change From Baseline in Blood Pressure

    SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 4, 7, 9, and 10

  80. Period 1: Absolute Values of Blood Pressure

    SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.

    Time frame: Baseline and at Days 2, 3, 4, 5 and 7

  81. Period 2: Absolute Values of Blood Pressure

    SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.

    Time frame: Baseline and at Days 4, 7, 9, and 10

  82. Period 2: AUC (0-tau) of GSK3640254

    Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

  83. Period 2: Cmax of GSK3640254

    Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

  84. Period 2: Ctau of GSK3640254

    Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 1 and 2 hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

  85. Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254

    Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

  86. Period 1: Tmax of TAF

    Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

  87. Period 2: Tmax of TAF

    Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

  88. Period 1: Tmax of FTC

    Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

  89. Period 2: Tmax of FTC

    Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

  90. Period 1: Tmax of TFV

    Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

  91. Period 2: Tmax of TFV

    Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.

    Time frame: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

07

Results

Posted Apr 2, 2020

Participant flow

This was an open-label, single-sequence one-way interaction drug interaction study to investigate the effect of GSK3640254 on the pharmacokinetics (PK) of tenofovir alafenamide (TAF) and emtricitabine (FTC).

Treatment Period 1 (Up to Day 14)
Participant flow — Treatment Period 1 (Up to Day 14)
MilestoneTAF/FTC Followed by TAF/FTC+GSK3640254
Started16
Completed16
Not completed0
Treatment Period 2 (Up to Day 7)
Participant flow — Treatment Period 2 (Up to Day 7)
MilestoneTAF/FTC Followed by TAF/FTC+GSK3640254
Started16
Completed15
Not completed1
Withdrew: Adverse event1

Outcome measures

PrimaryPeriod 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing Interval at Steady State (AUC [0-tau]) of TAF

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. PK Parameter Population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated.

Time frame:
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Reported as:
Geometric mean · Hours*nanogram per milliliter
Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing Interval at Steady State (AUC [0-tau]) of TAF
Hours*nanogram per milliliterTAF/FTC
Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing Interval at Steady State (AUC [0-tau]) of TAF250.4 ± 58.2
PrimaryPeriod 2: AUC (0-tau) of TAF

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Reported as:
Geometric mean · Hours*nanogram per milliliter
Period 2: AUC (0-tau) of TAF
Hours*nanogram per milliliterTAF/FTC+GSK3640254
Period 2: AUC (0-tau) of TAF215.4 ± 36.3
PrimaryPeriod 1: Maximum Observed Concentration (Cmax) of TAF

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Reported as:
Geometric mean · Nanogram per milliliter
Period 1: Maximum Observed Concentration (Cmax) of TAF
Nanogram per milliliterTAF/FTC
Period 1: Maximum Observed Concentration (Cmax) of TAF203.4 ± 56.1
PrimaryPeriod 2: Cmax of TAF

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Reported as:
Geometric mean · Nanogram per milliliter
Period 2: Cmax of TAF
Nanogram per milliliterTAF/FTC+GSK3640254
Period 2: Cmax of TAF175.1 ± 44.4
PrimaryPeriod 1: AUC (0-tau) of FTC

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Reported as:
Geometric mean · Hours*nanogram per milliliter
Period 1: AUC (0-tau) of FTC
Hours*nanogram per milliliterTAF/FTC
Period 1: AUC (0-tau) of FTC9787.5 ± 15.5
PrimaryPeriod 2: AUC (0-tau) of FTC

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Reported as:
Geometric mean · Hours*nanogram per milliliter
Period 2: AUC (0-tau) of FTC
Hours*nanogram per milliliterTAF/FTC+GSK3640254
Period 2: AUC (0-tau) of FTC9421.0 ± 14.4
PrimaryPeriod 1:Cmax of FTC

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Reported as:
Geometric mean · Nanogram per milliliter
Period 1:Cmax of FTC
Nanogram per milliliterTAF/FTC
Period 1:Cmax of FTC1811 ± 15.9
PrimaryPeriod 2:Cmax of FTC

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Reported as:
Geometric mean · Nanogram per milliliter
Period 2:Cmax of FTC
Nanogram per milliliterTAF/FTC+GSK3640254
Period 2:Cmax of FTC1701 ± 20.9
PrimaryPeriod 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of FTC

Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Reported as:
Geometric mean · Nanogram per milliliter
Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of FTC
Nanogram per milliliterTAF/FTC
Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of FTC71.81 ± 25.5
PrimaryPeriod 2: Ctau of FTC

Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Reported as:
Geometric mean · Nanogram per milliliter
Period 2: Ctau of FTC
Nanogram per milliliterTAF/FTC+GSK3640254
Period 2: Ctau of FTC82.92 ± 29.1
PrimaryPeriod 1: AUC (0-tau) of Tenofovir (TFV)

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Reported as:
Geometric mean · Hours*nanogram per milliliter
Period 1: AUC (0-tau) of Tenofovir (TFV)
Hours*nanogram per milliliterTAF/FTC
Period 1: AUC (0-tau) of Tenofovir (TFV)221.9 ± 18.3
PrimaryPeriod 2: AUC (0-tau) of TFV

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Reported as:
Geometric mean · Hours*nanogram per milliliter
Period 2: AUC (0-tau) of TFV
Hours*nanogram per milliliterTAF/FTC+GSK3640254
Period 2: AUC (0-tau) of TFV229.1 ± 21.5
PrimaryPeriod 1: Cmax of TFV

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Reported as:
Geometric mean · Nanogram per milliliter
Period 1: Cmax of TFV
Nanogram per milliliterTAF/FTC
Period 1: Cmax of TFV13.14 ± 17.8
PrimaryPeriod 2: Cmax of TFV

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Reported as:
Geometric mean · Nanogram per milliliter
Period 2: Cmax of TFV
Nanogram per milliliterTAF/FTC+GSK3640254
Period 2: Cmax of TFV13.30 ± 20.8
PrimaryPeriod 1: Ctau of TFV

Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Reported as:
Geometric mean · Nanogram per milliliter
Period 1: Ctau of TFV
Nanogram per milliliterTAF/FTC
Period 1: Ctau of TFV7.688 ± 20.4
PrimaryPeriod 2: Ctau of TFV

Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Reported as:
Geometric mean · Nanogram per milliliter
Period 2: Ctau of TFV
Nanogram per milliliterTAF/FTC+GSK3640254
Period 2: Ctau of TFV8.244 ± 22.9
SecondaryNumber of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE)

An adverse events (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An 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; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before

Time frame:
Up to Day 24
Reported as:
Number · Participants
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE)
ParticipantsTAF/FTCTAF/FTC+GSK3640254
Non-SAEs93
SAEs00
SecondaryPeriod 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils

Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 7, and 14
Reported as:
Mean · Giga cells per liter
Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Giga cells per literTAF/FTC
Basophils, Period 1 Day 7-0.005 ± 0.0167
Basophils, Period 1 Day 14-0.006 ± 0.0260
Eosinophils, Period 1 Day 7-0.021 ± 0.0795
Eosinophils, Period 1 Day 14-0.020 ± 0.1531
Monocytes, Period 1 Day 70.014 ± 0.1808
Monocytes, Period 1 Day 140.049 ± 0.2718
Leukocytes, Period 1 Day 7-0.08 ± 1.795
Leukocytes, Period 1 Day 140.27 ± 2.191
Lymphocytes, Period 1 Day 7-0.246 ± 0.3089
Lymphocytes, Period 1 Day 14-0.262 ± 0.4138
Neutrophils, Period 1 Day 70.188 ± 1.5473
Neutrophils, Period 1 Day 140.513 ± 1.7986
Platelets, Period 1 Day 73.3 ± 21.23
Platelets, Period 1 Day 1421.8 ± 35.37
SecondaryPeriod 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils

Blood samples were collected at indicated timepoints for analysis for hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · Giga cells per liter
Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Giga cells per literTAF/FTC+GSK3640254
Basophils, Period 2 Day 3, n= 15-0.004 ± 0.0196
Basophils, Period 2 Day 7, n= 15-0.002 ± 0.0204
Basophils, Period 2 Day 9, n= 150.003 ± 0.0150
Eosinophils, Period 2 Day 3, n=15-0.023 ± 0.0811
Eosinophils, Period 2 Day 7, n=15-0.039 ± 0.1058
Eosinophils, Period 2 Day 9, n=16-0.043 ± 0.1093
Monocytes, Period 2 Day 3, n= 16-0.053 ± 0.1895
Monocytes, Period 2 Day 7, n= 15-0.077 ± 0.1709
Monocytes, Period 2 Day 9, n= 15-0.104 ± 0.1672
Leukocytes, Period 2 Day 3, n= 16-1.06 ± 1.188
Leukocytes, Period 2 Day 7, n= 15-0.61 ± 1.050
Leukocytes, Period 2 Day 9, n= 15-0.49 ± 1.193
Lymphocytes, Period 2 Day 3, n= 16-0.158 ± 0.2296
Lymphocytes, Period 2 Day 7, n= 15-0.105 ± 0.2306
Lymphocytes, Period 2 Day 9, n= 15-0.111 ± 0.2728
Neutrophils, Period 2 Day 3, n= 16-0.868 ± 0.9597
Neutrophils, Period 2 Day 7, n= 15-0.417 ± 0.9069
Neutrophils, Period 2 Day 9, n= 15-0.282 ± 1.0161
Platelets, Period 2 Day 3, n= 169.2 ± 20.41
Platelets, Period 2 Day 7, n= 1519.8 ± 43.02
Platelets, Period 2 Day 9, n= 1516.2 ± 38.11
SecondaryPeriod 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils

Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Day -1 for Period 1.

Time frame:
Baseline and at Days 7, and 14
Reported as:
Mean · Giga cells per liter
Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Giga cells per literTAF/FTC
Basophils, Period 1 Baseline0.046 ± 0.0216
Basophils, Period 1 Day 70.041 ± 0.0189
Basophils, Period 1 Day 140.040 ± 0.0256
Eosinophils, Period 1 Baseline0.225 ± 0.1918
Eosinophils, Period 1 Day 70.204 ± 0.1737
Eosinophils, Period 1 Day 140.205 ± 0.1766
Monocytes, Period 1 Baseline0.522 ± 0.1147
Monocytes, Period 1 Day 70.536 ± 0.2063
Monocytes, Period 1 Day 140.571 ± 0.2830
Leukocytes, Period 1 Baseline6.18 ± 1.336
Leukocytes, Period 1 Day 76.10 ± 2.024
Leukocytes, Period 1 Day 146.45 ± 2.231
Lymphocytes, Period 1 Baseline1.945 ± 0.7419
Lymphocytes, Period 1 Day 71.699 ± 0.5822
Lymphocytes, Period 1 Day 141.683 ± 0.4988
Neutrophils, Period 1 Baseline3.441 ± 0.9719
Neutrophils, Period 1 Day 73.628 ± 1.9503
Neutrophils, Period 1 Day 143.954 ± 1.9141
Platelets, Period 1 Baseline253.3 ± 49.81
Platelets, Period 1 Day 7256.6 ± 49.72
Platelets, Period 1 Day 14275.1 ± 53.39
SecondaryPeriod 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils

Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Period 1 Day 14 for Period 2.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · Giga cells per liter
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Giga cells per literTAF/FTC+GSK3640254
Basophils, Period 2 Baseline, n= 160.040 ± 0.0256
Basophils, Period 2 Day 3, n= 150.036 ± 0.0182
Basophils, Period 2 Day 7, n= 150.038 ± 0.0152
Basophils, Period 2 Day 9, n= 150.043 ± 0.0232
Eosinophils, Period 2 Baseline, n= 160.208 ± 0.1764
Eosinophils, Period 2 Day 3, n= 150.185 ± 0.1533
Eosinophils, Period 2 Day 7, n= 150.157 ± 0.1405
Eosinophils, Period 2 Day 9, n= 160.153 ± 0.1384
Monocytes, Period 2 Baseline, n= 160.545 ± 0.2127
Monocytes, Period 2 Day 3, n= 160.492 ± 0.1975
Monocytes, Period 2 Day 7, n= 150.448 ± 0.1472
Monocytes, Period 2 Day 9, n= 150.421 ± 0.1212
Leukocytes, Period 2 Baseline, n= 166.20 ± 1.752
Leukocytes, Period 2 Day 3, n= 165.14 ± 1.035
Leukocytes, Period 2 Day 7, n= 155.39 ± 1.311
Leukocytes, Period 2 Day 9, n= 155.51 ± 1.415
Lymphocytes, Period 2 Baseline, n= 161.718 ± 0.4814
Lymphocytes, Period 2 Day 3, n= 161.560 ± 0.3786
Lymphocytes, Period 2 Day 7, n= 151.570 ± 0.4116
Lymphocytes, Period 2 Day 9, n= 151.563 ± 0.4236
Neutrophils, Period 2 Baseline, n= 163.724 ± 1.3787
Neutrophils, Period 2 Day 3, n= 162.857 ± 0.8106
Neutrophils, Period 2 Day 7, n= 153.189 ± 1.0515
Neutrophils, Period 2 Day 9, n= 153.324 ± 1.1988
Platelets, Period 2 Baseline, n= 16274.3 ± 51.10
Platelets, Period 2 Day 3, n= 16283.4 ± 54.62
Platelets, Period 2 Day 7, n= 15294.0 ± 54.62
Platelets, Period 2 Day 9, n= 15290.4 ± 73.92
SecondaryPeriod 1: Change From Baseline in Hematology Parameter of Hematocrit

Blood samples were collected at indicated timepoints for analysis of hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · Proportion of red blood cells in blood
Period 1: Change From Baseline in Hematology Parameter of Hematocrit
Proportion of red blood cells in bloodTAF/FTC
Day 70.0121 ± 0.01389
Day 140.0189 ± 0.01304
SecondaryPeriod 2: Change From Baseline in Hematology Parameter of Hematocrit

Blood samples were collected at indicated time-points for analysis for hematology parameter like hematocrit. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · Proportion of red blood cells in blood
Period 2: Change From Baseline in Hematology Parameter of Hematocrit
Proportion of red blood cells in bloodTAF/FTC+GSK3640254
Day 3, n= 16-0.0147 ± 0.00982
Day 7, n= 15-0.0007 ± 0.01369
Day 9, n= 15-0.0204 ± 0.01371
SecondaryPeriod 1: Absolute Values of the Hematology Parameter: Hematocrit

Blood samples were collected at indicated time points for analysis for hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · Proportion of red blood cells in blood
Period 1: Absolute Values of the Hematology Parameter: Hematocrit
Proportion of red blood cells in bloodTAF/FTC
Baseline0.4264 ± 0.01891
Day 70.4384 ± 0.02358
Day 140.4453 ± 0.01997
SecondaryPeriod 2: Absolute Values of the Hematology Parameter: Hematocrit

Blood samples were collected at indicated time-points for analysis for hematology parameter like hematocrit. Baseline was defined as Period 1 Day 14 for Period 2.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · Proportion of red blood cells in blood
Period 2: Absolute Values of the Hematology Parameter: Hematocrit
Proportion of red blood cells in bloodTAF/FTC+GSK3640254
Baseline, n= 160.4453 ± 0.01997
Day 3, n= 160.4306 ± 0.01780
Day 7, n= 150.4444 ± 0.02234
Day 9, n= 150.4247 ± 0.01518
SecondaryPeriod 1: Change From Baseline in Hematology Parameter of Hemoglobin

Blood samples were collected at indicated timepoints for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · Grams per liter
Period 1: Change From Baseline in Hematology Parameter of Hemoglobin
Grams per literTAF/FTC
Day 76.1 ± 4.51
Day 148.4 ± 3.98
SecondaryPeriod 2: Change From Baseline in Hematology Parameter of Hemoglobin

Blood samples were collected at indicated timepoints for analysis of hematology parameter like hemoglobin. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · Grams per liter
Period 2: Change From Baseline in Hematology Parameter of Hemoglobin
Grams per literTAF/FTC+GSK3640254
Day 3, n= 16-3.9 ± 3.51
Day 7, n= 15-1.1 ± 4.58
Day 9, n= 15-6.4 ± 5.55
SecondaryPeriod 1: Absolute Values of the Hematology Parameter: Hemoglobin

Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · Grams per liter
Period 1: Absolute Values of the Hematology Parameter: Hemoglobin
Grams per literTAF/FTC
Baseline142.0 ± 6.70
Day 7148.1 ± 8.11
Day 14150.4 ± 7.45
SecondaryPeriod 2: Absolute Values of the Hematology Parameter: Hemoglobin

Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Period 1 Day 14 for Period 2.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · Grams per liter
Period 2: Absolute Values of the Hematology Parameter: Hemoglobin
Grams per literTAF/FTC+GSK3640254
Baseline, n= 16150.4 ± 7.45
Day 3, n= 16146.4 ± 6.37
Day 7, n= 15149.1 ± 7.26
Day 9, n= 15143.9 ± 5.19
SecondaryPeriod 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH)

Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCH. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · Picograms
Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH)
PicogramsTAF/FTC
Day 70.13 ± 0.272
Day 140.36 ± 0.276
SecondaryPeriod 2: Change From Baseline in Hematology Parameter of MCH

Blood samples were collected at indicated timepoints for analysis for hematology parameter like MCH. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · Picograms
Period 2: Change From Baseline in Hematology Parameter of MCH
PicogramsTAF/FTC+GSK3640254
Day 3, n= 16-0.11 ± 0.205
Day 7, n= 15-0.21 ± 0.203
Day 9, n= 15-0.17 ± 0.253
SecondaryPeriod 1: Absolute Values of the Hematology Parameter: MCH

Blood samples were collected at indicated time-points for analysis for hematology parameter like MCH. Baseline was defined as Day -1 for Period 1.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · Picograms
Period 1: Absolute Values of the Hematology Parameter: MCH
PicogramsTAF/FTC
Baseline28.63 ± 1.780
Day 728.75 ± 1.687
Day 1428.98 ± 1.690
SecondaryPeriod 2: Absolute Values of the Hematology Parameter: MCH

Blood samples were collected at indicated time-points for analysis of hematology parameter like MCH. Baseline was defined as Period 1 Day 14 for Period 2.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · Picograms
Period 2: Absolute Values of the Hematology Parameter: MCH
PicogramsTAF/FTC+GSK3640254
Baseline, n= 1628.98 ± 1.690
Day 3, n= 1628.88 ± 1.699
Day 7, n= 1528.83 ± 1.630
Day 9, n= 1528.87 ± 1.702
SecondaryPeriod 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV)

Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · Femtoliters
Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV)
FemtolitersTAF/FTC
Day 7-0.83 ± 0.620
Day 14-0.07 ± 0.712
SecondaryPeriod 2: Change From Baseline in Hematology Parameter of MCV

Blood samples were collected at indicated timepoints for analysis for hematology parameter like MCV. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · Femtoliters
Period 2: Change From Baseline in Hematology Parameter of MCV
FemtolitersTAF/FTC+GSK3640254
Day 3, n= 16-1.02 ± 0.483
Day 7, n= 15-0.17 ± 0.472
Day 9, n= 15-0.82 ± 0.499
SecondaryPeriod 1: Absolute Values of the Hematology Parameter: MCV

Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · Femtoliters
Period 1: Absolute Values of the Hematology Parameter: MCV
FemtolitersTAF/FTC
Baseline85.92 ± 4.690
Day 785.09 ± 4.504
Day 1485.85 ± 4.492
SecondaryPeriod 2: Absolute Values of the Hematology Parameter: MCV

Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Period 1 Day 14 for Period 2.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · Femtoliters
Period 2: Absolute Values of the Hematology Parameter: MCV
FemtolitersTAF/FTC+GSK3640254
Baseline, n= 1685.85 ± 4.492
Day 3, n= 1684.83 ± 4.490
Day 7, n= 1585.85 ± 4.491
Day 9, n= 1585.20 ± 4.601
SecondaryPeriod 1: Change From Baseline in Hematology Parameter of Erythrocytes

Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · Trillion cells per liter
Period 1: Change From Baseline in Hematology Parameter of Erythrocytes
Trillion cells per literTAF/FTC
Day 70.189 ± 0.1485
Day 140.226 ± 0.1360
SecondaryPeriod 2: Change From Baseline in Hematology Parameter of Erythrocytes

Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · Trillion cells per liter
Period 2: Change From Baseline in Hematology Parameter of Erythrocytes
Trillion cells per literTAF/FTC+GSK3640254
Day 3, n= 16-0.113 ± 0.1123
Day 7, n= 150.000 ± 0.1466
Day 9, n= 15-0.189 ± 0.1697
SecondaryPeriod 1: Absolute Values of the Hematology Parameter: Erythrocytes

Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · Trillion cells per liter
Period 1: Absolute Values of the Hematology Parameter: Erythrocytes
Trillion cells per literTAF/FTC
Baseline4.977 ± 0.3351
Day 75.166 ± 0.3679
Day 145.203 ± 0.3604
SecondaryPeriod 2: Absolute Values of the Hematology Parameter: Erythrocytes

Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Period 1 Day 14 for Period 2.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · Trillion cells per liter
Period 2: Absolute Values of the Hematology Parameter: Erythrocytes
Trillion cells per literTAF/FTC+GSK3640254
Baseline, n= 165.203 ± 0.3604
Day 3, n= 165.090 ± 0.3395
Day 7, n= 155.190 ± 0.4087
Day 9, n= 155.001 ± 0.3446
SecondaryPeriod 1: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), Carbon Dioxide (CO2), Chloride and Phosphorus

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · Millimoles per Liter
Period 1: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), Carbon Dioxide (CO2), Chloride and Phosphorus
Millimoles per LiterTAF/FTC
Glucose, Day 7-0.160 ± 0.3793
Glucose, Day 14-0.320 ± 0.3432
Cholesterol, Day 7-0.004 ± 0.3735
Cholesterol, Day 14-0.389 ± 0.3533
Anion gap, Day 71.9 ± 2.08
Anion gap, Day 142.2 ± 1.42
Calcium, Day 70.028 ± 0.0780
Calcium, Day 140.028 ± 0.0556
CO2, Day 7-1.6 ± 1.93
CO2, Day 14-0.9 ± 1.20
Chloride, Day 7-1.1 ± 1.06
Chloride, Day 14-2.0 ± 1.46
Phosphate, Day 70.017 ± 0.0960
Phosphate, Day 140.026 ± 0.1330
Potassium, Day 70.03 ± 0.304
Potassium, Day 14-0.03 ± 0.328
Sodium, Day 7-0.6 ± 1.45
Sodium, Day 14-0.6 ± 1.59
Triglycerides, Day 70.092 ± 0.4841
Triglycerides, Day 14-0.044 ± 0.4569
BUN, Day 7-0.018 ± 1.2157
BUN, Day 14-0.195 ± 1.0640
SecondaryPeriod 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · Millimoles per Liter
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Millimoles per LiterTAF/FTC+GSK3640254
Glucose, Day 3, n= 150.236 ± 0.2463
Glucose, Day 7, n= 150.315 ± 0.3282
Glucose, Day 9, n= 150.136 ± 0.2433
Cholesterol, Day 3, n=150.011 ± 0.2372
Cholesterol, Day 7, n= 150.102 ± 0.3899
Cholesterol, Day 9, n= 160.030 ± 0.4594
Anion gap, Day 3, n= 16-0.4 ± 1.82
Anion gap, Day 7, n= 15-0.5 ± 1.73
Anion gap, Day 9, n= 15-0.3 ± 1.67
Calcium, Day 3, n= 160.013 ± 0.0478
Calcium, Day 7, n= 150.037 ± 0.0568
Calcium, Day 9, n= 150.033 ± 0.0628
CO2, Day 3, n= 16-0.5 ± 1.26
CO2, Day 7, n= 15-0.1 ± 1.36
CO2, Day 9, n= 15-0.4 ± 1.18
Chloride, Day 3, n= 162.3 ± 1.20
Chloride, Day 7, n= 150.6 ± 1.35
Chloride, Day 9, n= 151.3 ± 1.72
Phosphate, Day 3, n= 160.062 ± 0.0683
Phosphate, Day 7, n= 150.002 ± 0.0800
Phosphate, Day 9, n= 150.007 ± 0.0584
Potassium, Day 3, n= 160.01 ± 0.284
Potassium, Day 7, n= 15-0.03 ± 0.213
Potassium, Day 9, n= 150.10 ± 0.344
Sodium, Day 3, n= 161.4 ± 1.36
Sodium, Day 7, n= 150.1 ± 1.53
Sodium, Day 9, n= 150.6 ± 1.06
Triglycerides, Day 3, n= 16-0.003 ± 0.1753
Triglycerides, Day 7, n= 150.111 ± 0.2414
Triglycerides, Day 9, n= 15-0.049 ± 0.2747
BUN, Day 3, n= 160.312 ± 0.5567
BUN, Day 7, n= 15-0.031 ± 0.5038
BUN, Day 9, n= 15-0.028 ± 0.4521
SecondaryPeriod 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus

Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Day -1 for Period 1.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · Millimoles per Liter
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Millimoles per LiterTAF/FTC
Glucose, Baseline5.111 ± 0.3747
Glucose, Day 74.951 ± 0.2587
Glucose, Day 144.791 ± 0.2662
Cholesterol, Baseline4.253 ± 0.7938
Cholesterol, Day 74.249 ± 0.8494
Cholesterol, Day 143.864 ± 0.6087
Anion gap, Baseline8.7 ± 1.08
Anion gap, Day 710.6 ± 2.25
Anion gap, Day 1410.9 ± 1.45
Calcium, Baseline2.359 ± 0.0697
Calcium, Day 72.387 ± 0.0663
Calcium, Day 142.387 ± 0.0637
CO2, Baseline31.7 ± 1.49
CO2, Day 730.1 ± 1.86
CO2, Day 1430.8 ± 1.38
Chloride, Baseline103.3 ± 1.84
Chloride, Day 7102.2 ± 1.72
Chloride, Day 14101.3 ± 2.32
Phosphate, Baseline1.078 ± 0.1301
Phosphate, Day 71.094 ± 0.1202
Phosphate, Day 141.103 ± 0.0807
Potassium, Baseline4.25 ± 0.225
Potassium, Day 74.28 ± 0.161
Potassium, Day 144.22 ± 0.279
Sodium, Baseline139.4 ± 1.45
Sodium, Day 7138.8 ± 1.77
Sodium, Day 14138.8 ± 1.69
Triglycerides, Baseline1.076 ± 0.5825
Triglycerides, Day 71.168 ± 0.3759
Triglycerides, Day 141.033 ± 0.3034
BUN, Baseline4.441 ± 1.2792
BUN, Day 74.423 ± 0.9623
BUN, Day 144.246 ± 0.7820
SecondaryPeriod 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Period 1 Day 14 for Period 2.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · Millimoles per Liter
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Millimoles per LiterTAF/FTC+GSK3640254
Glucose, Baseline, n= 164.791 ± 0.2662
Glucose, Day 3, n= 155.027 ± 0.2894
Glucose, Day 7, n= 155.129 ± 0.3388
Glucose, Day 9, n= 154.950 ± 0.3360
Cholesterol, Baseline, n= 163.864 ± 0.6087
Cholesterol, Day 3, n=153.875 ± 0.6509
Cholesterol, Day 7, n= 153.894 ± 0.7575
Cholesterol, Day 9, n= 163.822 ± 0.7838
Anion gap, Baseline, n= 1610.9 ± 1.45
Anion gap, Day 3, n= 1610.5 ± 1.37
Anion gap, Day 7, n= 1510.3 ± 1.28
Anion gap, Day 9, n= 1510.5 ± 0.74
Calcium, Baseline, n= 162.387 ± 0.0637
Calcium, Day 3, n= 162.399 ± 0.0682
Calcium, Day 7, n= 152.424 ± 0.0693
Calcium, Day 9, n= 152.421 ± 0.0670
CO2, Baseline, n= 1630.8 ± 1.38
CO2, Day 3, n= 1630.3 ± 1.96
CO2, Day 7, n= 1530.7 ± 1.91
CO2, Day 9, n= 1530.5 ± 1.30
Chloride, Baseline, n= 16101.3 ± 2.32
Chloride, Day 3, n= 16103.6 ± 1.50
Chloride, Day 7, n= 15101.9 ± 1.62
Chloride, Day 9, n= 15102.7 ± 1.50
Phosphate, Baseline, n= 161.103 ± 0.0807
Phosphate, Day 3, n= 161.165 ± 0.1007
Phosphate, Day 7, n= 151.112 ± 0.1097
Phosphate, Day 9, n= 151.117 ± 0.0952
Potassium, Baseline, n= 164.22 ± 0.279
Potassium, Day 3, n= 164.23 ± 0.241
Potassium, Day 7, n= 154.21 ± 0.236
Potassium, Day 9, n= 154.35 ± 0.226
Sodium, Baseline, n= 16138.8 ± 1.69
Sodium, Day 3, n= 16140.2 ± 1.56
Sodium, Day 7, n= 15138.8 ± 1.42
Sodium, Day 9, n=15139.3 ± 1.18
Triglycerides, Baseline, n= 161.033 ± 0.3034
Triglycerides, Day 3, n= 161.029 ± 0.3440
Triglycerides, Day 7, n= 151.120 ± 0.4358
Triglycerides, Day 9, n= 150.961 ± 0.4320
BUN, Baseline, n= 164.246 ± 0.7820
BUN, Day 3, n= 164.558 ± 0.8267
BUN, Day 7, n= 154.260 ± 0.8705
BUN Day 9, n= 154.263 ± 0.6977
SecondaryPeriod 1: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH), Gamma-glutamyl Transferase (GGT), and Creatine Phosphokinase (CK)

Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter like alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · International units per Liter
Period 1: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH), Gamma-glutamyl Transferase (GGT), and Creatine Phosphokinase (CK)
International units per LiterTAF/FTC
Alkaline phosphatase, Day 7-2.6 ± 5.10
Alkaline phosphatase, Day 142.4 ± 6.91
AST, Day 7-6.2 ± 4.59
AST, Day 14-6.9 ± 4.95
ALT, Day 7-2.1 ± 7.26
ALT, Day 14-6.2 ± 6.98
GGT Day 70.2 ± 2.32
GGT Day 14-1.7 ± 3.63
LDH, Day 7-14.6 ± 13.07
LDH, Day 14-12.0 ± 16.25
CK, Day 7-103.0 ± 127.10
CK, Day 14-99.2 ± 135.80
SecondaryPeriod 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · International units per Liter
Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
International units per LiterTAF/FTC+GSK3640254
Alkaline phosphatase, Day 3, n= 163.7 ± 3.48
Alkaline phosphatase, Day 7, n= 152.6 ± 3.64
Alkaline phosphatase, Day 9, n= 15-1.0 ± 3.98
AST, Day 3, n= 16-1.4 ± 1.31
AST, Day 7, n= 15-0.5 ± 2.45
AST, Day 9, n= 15-0.1 ± 2.13
ALT, Day 3, n= 16-2.0 ± 1.63
ALT, Day 7, n= 15-1.9 ± 2.76
ALT, Day 9, n= 15-0.7 ± 4.56
GGT, Day 3, n= 16-0.9 ± 1.18
GGT, Day 7, n= 15-1.4 ± 1.50
GGT, Day 9, n= 15-1.9 ± 2.55
LDH, Day 3, n= 16-7.0 ± 11.98
LDH, Day 7, n= 15-8.2 ± 12.73
LDH, Day 9, n= 15-7.0 ± 11.98
CK, Day 3, n= 163.4 ± 29.12
CK, Day 7, n= 1511.3 ± 33.83
CK, Day 9, n= 15-2.3 ± 22.65
SecondaryPeriod 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Day -1 for Period 1.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · International units per Liter
Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
International units per LiterTAF/FTC
Alkaline phosphatase, Baseline60.9 ± 9.33
Alkaline phosphatase, Day 758.3 ± 8.36
Alkaline phosphatase, Day 1463.4 ± 8.82
AST, Baseline24.6 ± 6.16
AST, Day 718.4 ± 4.79
AST, Day 1417.6 ± 3.46
ALT, Baseline26.6 ± 10.44
ALT, Day 724.4 ± 13.28
ALT, Day 1420.4 ± 8.59
GGT Baseline1.76 ± 1.016
GGT Day 71.91 ± 0.752
GGT Day 142.40 ± 1.035
LDH, Baseline138.0 ± 19.77
LDH, Day 7123.4 ± 19.67
LDH, Day 9126.0 ± 19.50
CK, Baseline219.6 ± 150.90
CK, Day 7116.6 ± 49.16
CK, Day 14120.4 ± 62.41
SecondaryPeriod 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Period 1 Day 14 for Period 2.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · International units per Liter
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
International units per LiterTAF/FTC+GSK3640254
Alkaline phosphatase, Baseline Day 3, n= 1663.4 ± 8.82
Alkaline phosphatase, Day 3, n= 1667.1 ± 10.45
Alkaline phosphatase, Day 7, n= 1565.4 ± 9.81
Alkaline phosphatase, Day 9, n= 1561.8 ± 9.65
AST, Baseline, n= 1617.6 ± 3.46
AST, Day 3, n= 1616.2 ± 3.04
AST, Day 7, n= 1517.2 ± 3.38
AST, Day 9, n= 1517.6 ± 3.83
ALT, Baseline, n= 1620.4 ± 8.59
ALT, Day 3, n= 1618.4 ± 7.87
ALT, Day 7, n= 1518.5 ± 8.31
ALT, Day 9, n= 1519.7 ± 9.43
GGT, Baseline, n= 162.40 ± 1.035
GGT, Day 3, n= 162.14 ± 1.065
GGT, Day 7, n= 152.41 ± 0.828
GGT, Day 9, n= 151.95 ± 0.673
LDH, Baseline, n= 16126.0 ± 19.50
LDH, Day 3, n= 16119.0 ± 19.37
LDH, Day 7, n= 15118.0 ± 13.93
LDH, Day 9, n= 15119.2 ± 17.70
CK, Baseline, n= 16120.4 ± 62.41
CK, Day 3, n= 16123.8 ± 51.53
CK, Day 7, n= 15135.8 ± 66.33
CK, Day 9, n= 15122.2 ± 54.94
SecondaryPeriod 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · Units per Liter
Period 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase
Units per LiterTAF/FTC
Amylase, Day 7-2.3 ± 9.68
Amylase, Day 14-2.8 ± 10.48
Lipase, Day 7-4.0 ± 8.93
Lipase, Day 14-5.3 ± 12.69
SecondaryPeriod 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · Units per Liter
Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase
Units per LiterTAF/FTC+GSK3640254
Amylase, Day 3, n= 163.3 ± 8.93
Amylase, Day 7, n= 15-1.9 ± 6.77
Amylase, Day 9, n= 151.1 ± 6.32
Lipase, Day 3, n= 167.7 ± 21.62
Lipase, Day 7, n= 150.0 ± 8.20
Lipase, Day 9, n= 153.5 ± 3.89
SecondaryPeriod 1: Absolute Values of Chemistry Parameters of Lipase and Amylase

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Day -1 for Period 1.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · Units per Liter
Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase
Units per LiterTAF/FTC
Amylase, Baseline56.4 ± 14.66
Amylase, Day 754.1 ± 13.15
Amylase, Day 1453.6 ± 14.48
Lipase, Baseline22.2 ± 14.00
Lipase, Day 718.2 ± 9.72
Lipase, Day 1416.9 ± 14.65
SecondaryPeriod 2: Absolute Values of Chemistry Parameters of Lipase and Amylase

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Period 1 Day 14 for Period 2.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · Units per Liter
Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase
Units per LiterTAF/FTC+GSK3640254
Amylase, Baseline, n= 1653.6 ± 14.48
Amylase, Day 3, n= 1656.8 ± 19.32
Amylase, Day 7, n= 1552.7 ± 12.97
Amylase, Day 9, n= 1555.7 ± 13.39
Lipase, Baseline, n= 1616.9 ± 14.65
Lipase, Day 3, n= 1624.6 ± 34.82
Lipase, Day 7, n= 1517.5 ± 10.69
Lipase, Day 9, n= 1521.0 ± 14.16
SecondaryPeriod 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · Micromoles per liter
Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Micromoles per literTAF/FTC
Creatinine, Day 75.69 ± 3.508
Creatinine, Day 147.36 ± 4.833
Total bilirubin, Day 72.25 ± 4.756
Total bilirubin, Day 142.10 ± 5.109
Direct bilirubin, Day 70.15 ± 0.634
Direct bilirubin, Day 140.64 ± 0.699
SecondaryPeriod 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · Micromoles per liter
Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Micromoles per literTAF/FTC+GSK3640254
Creatinine, Day 3, n= 16-2.34 ± 3.755
Creatinine, Day 7, n= 153.53 ± 3.802
Creatinine, Day 9, n= 150.28 ± 3.569
Total bilirubin, Day 3, n= 16-0.82 ± 3.475
Total bilirubin, Day 7, n= 15-0.26 ± 2.466
Total bilirubin, Day 9, n= 15-1.91 ± 2.252
Direct bilirubin, Day 3, n= 16-0.26 ± 0.534
Direct bilirubin, Day 7, n= 15-0.03 ± 0.547
Direct bilirubin, Day 9, n= 15-0.49 ± 0.501
SecondaryPeriod 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Day -1 for Period 1.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · Micromoles per liter
Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Micromoles per literTAF/FTC
Creatinine, Baseline80.16 ± 10.103
Creatinine, Day 785.85 ± 9.586
Creatinine, Day 1487.52 ± 10.058
Total bilirubin, Baseline9.64 ± 6.143
Total bilirubin, Day 711.89 ± 6.781
Total bilirubin, Day 1411.74 ± 7.046
Direct bilirubin, Baseline1.76 ± 1.016
Direct bilirubin, Day 71.91 ± 0.752
Direct bilirubin, Day 142.40 ± 1.035
SecondaryPeriod 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, creatinine and uric acid. Baseline was defined as Period 1 Day 14 for Period 2.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · Micromoles per liter
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Micromoles per literTAF/FTC+GSK3640254
Creatinine, Baseline, n= 1687.52 ± 10.058
Creatinine, Day 3, n= 1685.18 ± 10.314
Creatinine, Day 7, n= 1591.53 ± 9.504
Creatinine, Day 9, n= 1588.27 ± 9.916
Total bilirubin, Baseline, n= 1611.44 ± 6.022
Total bilirubin, Day 3, n= 1610.62 ± 7.886
Total bilirubin, Day 7, n= 1511.33 ± 5.487
Total bilirubin, Day 9, n= 159.68 ± 4.603
Direct bilirubin, Baseline, n= 162.40 ± 1.035
Direct bilirubin, Day 3, n= 162.14 ± 1.065
Direct bilirubin, Day 7, n= 152.41 ± 0.828
Direct bilirubin, Day 9, n= 151.95 ± 0.673
SecondaryPeriod 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of of total protein, albumin and globulin. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · Grams per Liter
Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Grams per LiterTAF/FTC
Total Protein, Day 72.6 ± 3.20
Total Protein, Day 142.9 ± 2.66
Globulin, Day 72.5 ± 1.37
Globulin, Day 142.8 ± 1.91
Albumin, Day 70.1 ± 2.22
Albumin, Day 140.1 ± 2.05
SecondaryPeriod 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total protein, albumin and globulin. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · Grams per Liter
Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Grams per LiterTAF/FTC+GSK3640254
Total Protein, Day 3, n= 160.1 ± 2.68
Total Protein, Day 7, n= 153.1 ± 2.85
Total Protein, Day 9, n= 150.8 ± 3.28
Globulin, Day 3, n= 160.2 ± 1.17
Globulin, Day 7, n= 152.3 ± 0.96
Globulin, Day 9, n= 150.2 ± 1.08
Albumin, Day 3, n= 16-0.1 ± 1.95
Albumin, Day 7, n= 150.9 ± 2.20
Albumin, Day 9, n= 150.6 ± 2.50
SecondaryPeriod 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total protein, albumin and globulin. Baseline was defined as Day -1 for Period 1.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · Grams per Liter
Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Grams per LiterTAF/FTC
Total Protein, Baseline69.8 ± 3.64
Total Protein, Day 772.4 ± 3.70
Total Protein, Day 1472.6 ± 3.10
Globulin, Baseline25.9 ± 2.50
Globulin, Day 728.4 ± 2.60
Globulin, Day 1428.7 ± 1.99
Albumin, Baseline43.9 ± 2.36
Albumin, Day 744.0 ± 1.90
Albumin, Day 1443.9 ± 2.41
SecondaryPeriod 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, creatinine and uric acid. Baseline was defined as Period 1 Day 14 for Period 2.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · Grams per Liter
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Grams per LiterTAF/FTC+GSK3640254
Total Protein, Baseline, n= 1672.6 ± 3.10
Total Protein, Day 3, n= 1672.8 ± 2.96
Total Protein, Day 7, n= 1575.7 ± 2.89
Total Protein, Day 9, n= 1573.3 ± 2.61
Globulin, Baseline, n= 1628.7 ± 1.99
Globulin, Day 3, n= 1628.9 ± 2.31
Globulin, Day 7, n= 1530.9 ± 1.96
Globulin, Day 9, n= 1528.8 ± 1.90
Albumin, Baseline, n= 1643.9 ± 2.41
Albumin, Day 3, n= 1643.9 ± 1.89
Albumin, Day 7, n= 1544.8 ± 2.08
Albumin, Day 9, n= 1544.5 ± 1.73
SecondaryPeriod 1: Change From Baseline in Specific Gravity of Urine

Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · Ratio
Period 1: Change From Baseline in Specific Gravity of Urine
RatioTAF/FTC
Day 70.0007 ± 0.01085
Day 140.0011 ± 0.00941
SecondaryPeriod 2: Change From Baseline in Specific Gravity of Urine

Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · Ratio
Period 2: Change From Baseline in Specific Gravity of Urine
RatioTAF/FTC+GSK3640254
Day 3, n= 160.0031 ± 0.00666
Day 7, n= 150.0024 ± 0.00608
Day 9, n= 150.0005 ± 0.00872
SecondaryPeriod 1: Absolute Values of Specific Gravity of Urine

Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Day -1 for Period 1.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · Ratio
Period 1: Absolute Values of Specific Gravity of Urine
RatioTAF/FTC
Baseline1.0136 ± 0.01095
Day 71.0143 ± 0.00556
Day 141.0147 ± 0.00789
SecondaryPeriod 2: Absolute Values of Specific Gravity of Urine

Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Period 1 Day 14 for Period 2.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · Ratio
Period 2: Absolute Values of Specific Gravity of Urine
RatioTAF/FTC+GSK3640254
Baseline, n= 161.0147 ± 0.00789
Day 3, n= 161.0178 ± 0.00584
Day 7, n= 151.0170 ± 0.00655
Day 9, n= 151.0151 ± 0.00788
SecondaryPeriod 1: Change From Baseline in Potential of Hydrogen (pH) of Urine

Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · pH
Period 1: Change From Baseline in Potential of Hydrogen (pH) of Urine
pHTAF/FTC
Day 7-0.34 ± 0.397
Day 14-0.19 ± 0.544
SecondaryPeriod 2: Change From Baseline in pH of Urine

Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · pH
Period 2: Change From Baseline in pH of Urine
pHTAF/FTC+GSK3640254
Day 3, n= 160.19 ± 0.479
Day 7, n= 150.10 ± 0.471
Day 9, n= 150.10 ± 0.507
SecondaryPeriod 1: Absolute Values of pH of Urine

Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Day -1 for Period 1.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · pH
Period 1: Absolute Values of pH of Urine
pHTAF/FTC
Baseline6.22 ± 0.446
Day 75.88 ± 0.289
Day 146.03 ± 0.531
SecondaryPeriod 2: Absolute Values of pH of Urine

Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Period 1 Day 14 for Period 2.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · pH
Period 2: Absolute Values of pH of Urine
pHTAF/FTC+GSK3640254
Baseline, n= 166.03 ± 0.531
Day 3, n= 166.22 ± 0.482
Day 7, n= 156.07 ± 0.320
Day 9, n= 156.07 ± 0.320
SecondaryPeriod 1: Change From Baseline in Urine Urobilinogen

Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · Micromoles per liter
Period 1: Change From Baseline in Urine Urobilinogen
Micromoles per literTAF/FTC
Day 7-2.5395 ± 5.45976
Day 14-2.5395 ± 5.45976
SecondaryPeriod 2: Change From Baseline in Urine Urobilinogen

Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · Micromoles per liter
Period 2: Change From Baseline in Urine Urobilinogen
Micromoles per literTAF/FTC+GSK3640254
Day 3, n= 160.0000 ± 0.00000
Day 7, n= 150.0000 ± 0.00000
Day 9, n= 150.0000 ± 0.00000
SecondaryPeriod 1: Absolute Values of Urine Urobilinogen

Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1.

Time frame:
Baseline and at Days 7, 14
Reported as:
Mean · Micromoles per liter
Period 1: Absolute Values of Urine Urobilinogen
Micromoles per literTAF/FTC
Baseline5.9255 ± 5.45976
Day 73.3860 ± 0.0000
Day 143.3860 ± 0.0000
SecondaryPeriod 2: Absolute Values of Urine Urobilinogen

Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Period 1 Day 14 for Period 2.

Time frame:
Baseline and at Days 3, 7, 9
Reported as:
Mean · Micromoles per liter
Period 2: Absolute Values of Urine Urobilinogen
Micromoles per literTAF/FTC+GSK3640254
Baseline, n= 163.3860 ± 0.0000
Day 3, n= 163.3860 ± 0.0000
Day 7, n= 153.3860 ± 0.0000
Day 9, n= 153.3860 ± 0.0000
SecondaryPeriod 1: Change From Baseline in Heart Rate

Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Day 1, 2 and 4 hours post-dose
Reported as:
Mean · Beats per minute
Period 1: Change From Baseline in Heart Rate
Beats per minuteTAF/FTC
Day 1, 2 hours post-dose1.5 ± 6.87
Day 1, 4 hours post-dose-3.3 ± 10.37
SecondaryPeriod 2: Change From Baseline in Heart Rate

Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose
Reported as:
Mean · Beats per minute
Period 2: Change From Baseline in Heart Rate
Beats per minuteTAF/FTC+GSK3640254
Day 1, 2 hours post-dose, n= 165.0 ± 4.37
Day 1, 4 hours post-dose, n= 162.8 ± 6.62
Day 4, Pre-dose, n= 15-0.5 ± 11.10
Day 4, 2 hours post-dose, n= 153.3 ± 5.86
Day 4, 4 hours post-dose, n= 15-0.3 ± 5.13
Day 7, Pre-dose, n= 150.3 ± 11.18
Day 7, 2 hours post-dose, n= 151.8 ± 6.72
Day 7, 4 hours post-dose, n= 15-2.3 ± 7.08
Day 9 post-dose, n= 152.1 ± 7.84
SecondaryPeriod 1: Absolute Values of Heart Rate

Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Day 1, 2 and 4 hours post-dose
Reported as:
Mean · Beats per minute
Period 1: Absolute Values of Heart Rate
Beats per minuteTAF/FTC
Baseline67.6 ± 8.72
Day 1, 2 hours post-dose69.1 ± 11.04
Day 1, 4 hours post-dose64.4 ± 11.87
SecondaryPeriod 2: Absolute Values of Heart Rate

Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period.

Time frame:
Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose
Reported as:
Mean · Beats per minute
Period 2: Absolute Values of Heart Rate
Beats per minuteTAF/FTC+GSK3640254
Baseline, n= 1666.5 ± 8.06
Day 1, 2 hours post-dose, n= 1671.5 ± 9.95
Day 1, 4 hours post-dose, n= 1669.3 ± 11.38
Day 4, Pre-dose, n= 1565.1 ± 10.48
Day 4, 2 hours post-dose, n= 1568.9 ± 8.00
Day 4, 4 hours post-dose, n= 1565.3 ± 8.97
Day 7, Pre-dose, n= 1565.9 ± 10.25
Day 7, 2 hours post-dose, n= 1567.4 ± 6.39
Day 7, 4 hours post-dose, n= 1563.3 ± 8.31
Day 9 post-dose, n= 1567.7 ± 9.23
SecondaryPeriod 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval

Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interal, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Day 1, 2 and 4 hours post-dose
Reported as:
Mean · Milliseconds
Period 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval
MillisecondsTAF/FTC
PR Interval, Day 1, 2 hours post-dose1.5 ± 9.67
PR Interval, Day 1, 4 hours post-dose-1.9 ± 8.64
QRS Duration, Day 1, 2 hours post-dose-1.1 ± 3.68
QRS Duration, Day 1, 4 hours post-dose0.3 ± 4.96
QT Interval, Day 1, 2 hours post-dose-7.5 ± 14.12
QT Interval, Day 1, 4 hours post-dose5.8 ± 23.18
QTcF Interval, Day 1, 2 hours post-dose-4.9 ± 10.63
QTcF Interval, Day 1, 4 hours post-dose-1.3 ± 10.56
QTcB Interval, Day 1, 2 hours post-dose-4.1 ± 12.70
QTcB Interval, Day 1, 4 hours post-dose-5.4 ± 12.39
SecondaryPeriod 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval

Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interal, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose
Reported as:
Mean · Milliseconds
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
MillisecondsTAF/FTC+GSK3640254
PR Interval, Day 1, 2 hours post-dose, n= 16-6.8 ± 6.77
PR Interval, Day 1, 4 hours post-dose, n= 16-3.7 ± 5.99
PR Interval, Day 4, Pre-dose, n= 15-0.5 ± 4.56
PR Interval, Day 4, 2 hours post-dose, n= 15-6.9 ± 6.67
PR Interval, Day 4, 4 hours post-dose, n= 15-3.9 ± 7.83
PR Interval, Day 7, Pre-dose, n= 15-2.7 ± 8.57
PR Interval, Day 7, 2 hours post-dose, n= 15-3.3 ± 7.06
PR Interval, Day 7, 4 hours post-dose, n= 15-3.7 ± 8.53
PR Interval, Day 9 post-dose, n= 151.2 ± 6.42
QRS Duration, Day 1, 2 hours post-dose, n= 16-2.5 ± 4.40
QRS Duration, Day 1, 4 hours post-dose, n= 16-1.4 ± 4.69
QRS Duration, Day 4, Pre-dose, n= 150.5 ± 3.44
QRS Duration, Day 4, 2 hours post-dose, n= 150.5 ± 5.72
QRS Duration, Day 4, 4 hours post-dose, n= 15-0.2 ± 2.70
QRS Duration, Day 7, Pre-dose, n= 153.3 ± 4.53
QRS Duration, Day 7, 2 hours post-dose, n= 151.5 ± 5.15
QRS Duration, Day 7, 4 hours post-dose, n= 150.3 ± 3.72
QRS Duration, Day 9 post-dose, n= 153.0 ± 5.36
QT Interval, Day 1, 2 hours post-dose, n= 16-12.6 ± 9.11
QT Interval, Day 1, 4 hours post-dose, n= 16-1.8 ± 14.72
QT Interval, Day 4, Pre-dose, n= 157.3 ± 18.27
QT Interval, Day 4, 2 hours post-dose, n= 15-6.8 ± 15.72
QT Interval, Day 4, 4 hours post-dose, n= 155.6 ± 14.64
QT Interval, Day 7, Pre-dose, n= 153.5 ± 18.31
QT Interval, Day 7, 2 hours post-dose, n= 15-8.4 ± 16.15
QT Interval, Day 7, 4 hours post-dose, n= 155.8 ± 17.37
QT Interval, Day 9 post-dose, n= 154.1 ± 16.46
QTcF Interval, Day 1, 2 hours post-dose, n= 16-4.4 ± 7.29
QTcF Interval, Day 1, 4 hours post-dose, n= 162.4 ± 7.77
QTcF Interval, Day 4, Pre-dose, n= 156.1 ± 11.17
QTcF Interval, Day 4, 2 hours post-dose, n= 15-0.6 ± 10.91
QTcF Interval, Day 4, 4 hours post-dose, n= 154.5 ± 8.22
QTcF Interval, Day 7, Pre-dose, n= 154.1 ± 8.71
QTcF Interval, Day 7, 2 hours post-dose, n= 15-5.1 ± 9.34
QTcF Interval, Day 7, 4 hours post-dose, n= 150.6 ± 9.03
QTcF Interval, Day 9 post-dose, n= 157.9 ± 8.53
QTcB Interval, Day 1, 2 hours post-dose, n= 160.7 ± 8.83
QTcB Interval, Day 1, 4 hours post-dose, n= 164.7 ± 8.49
QTcB Interval, Day 4, Pre-dose, n= 155.5 ± 18.50
QTcB Interval, Day 4, 2 hours post-dose, n= 152.5 ± 12.37
QTcB Interval, Day 4, 4 hours post-dose, n= 154.3 ± 8.52
QTcB Interval, Day 7, Pre-dose, n= 154.6 ± 16.31
QTcB Interval, Day 7, 2 hours post-dose, n= 15-3.2 ± 11.64
QTcB Interval, Day 7, 4 hours post-dose, n= 15-1.7 ± 12.06
QTcB Interval, Day 9 post-dose, n= 1510.3 ± 12.19
SecondaryPeriod 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval

Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period.

Time frame:
Baseline and at Day 1, 2 and 4 hours post-dose
Reported as:
Mean · Milliseconds
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
MillisecondsTAF/FTC
PR Interval, Baseline161.3 ± 16.53
PR Interval, Day 1, 2 hours post-dose162.8 ± 19.01
PR Interval, Day 1, 4 hours post-dose159.4 ± 19.47
QRS Duration, Baseline91.0 ± 8.22
QRS Duration, Day 1, 2 hours post-dose89.9 ± 7.54
QRS Duration, Day 1, 4 hours post-dose91.3 ± 8.14
QT Interval, Baseline377.8 ± 24.84
QT Interval, Day 1, 2 hours post-dose370.3 ± 24.74
QT Interval, Day 1, 4 hours post-dose383.6 ± 32.12
QTcF Interval, Baseline391.6 ± 12.92
QTcF Interval, Day 1, 2 hours post-dose386.7 ± 14.33
QTcF Interval, Day 1, 4 hours post-dose390.3 ± 18.27
QTcB Interval, Baseline398.8 ± 11.28
QTcB Interval, Day 1, 2 hours post-dose394.6 ± 15.14
QTcB Interval, Day 1, 4 hours post-dose393.3 ± 18.26
SecondaryPeriod 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval

Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period.

Time frame:
Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose
Reported as:
Mean · Milliseconds
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
MillisecondsTAF/FTC+GSK3640254
PR Interval, Baseline, n= 16167.3 ± 19.46
PR Interval, Day 1, 2 hours post-dose, n= 16160.4 ± 19.73
PR Interval, Day 1, 4 hours post-dose, n= 16163.6 ± 19.04
PR Interval, Day 4, Pre-dose, n= 15167.1 ± 22.20
PR Interval, Day 4, 2 hours post-dose, n= 15160.7 ± 19.59
PR Interval, Day 4, 4 hours post-dose, n= 15163.7 ± 19.29
PR Interval, Day 7, Pre-dose, n= 15164.9 ± 21.11
PR Interval, Day 7, 2 hours post-dose, n= 15164.3 ± 20.95
PR Interval, Day 7, 4 hours post-dose, n= 15163.9 ± 22.05
PR Interval, Day 9 post-dose, n= 15168.8 ± 23.70
QRS Duration, Baseline, n= 1691.4 ± 7.87
QRS Duration, Day 1, 2 hours post-dose, n= 1688.9 ± 8.20
QRS Duration, Day 1, 4 hours post-dose, n= 1690.1 ± 7.66
QRS Duration, Day 4, Pre-dose, n= 1591.8 ± 8.37
QRS Duration, Day 4, 2 hours post-dose, n= 1591.8 ± 9.12
QRS Duration, Day 4, 4 hours post-dose, n= 1591.1 ± 8.51
QRS Duration, Day 7, Pre-dose, n= 1594.5 ± 8.25
QRS Duration, Day 7, 2 hours post-dose, n= 1592.7 ± 7.49
QRS Duration, Day 7, 4 hours post-dose, n= 1591.6 ± 7.23
QRS Duration, Day 9 post-dose, n= 1594.3 ± 8.17
QT Interval, Baseline, n= 16377.7 ± 22.66
QT Interval, Day 1, 2 hours post-dose, n= 16365.1 ± 23.71
QT Interval, Day 1, 4 hours post-dose, n= 16375.9 ± 30.14
QT Interval, Day 4, Pre-dose, n= 15385.6 ± 26.65
QT Interval, Day 4, 2 hours post-dose, n= 15371.5 ± 27.31
QT Interval, Day 4, 4 hours post-dose, n= 15383.9 ± 31.05
QT Interval, Day 7, Pre-dose, n= 15381.7 ± 22.25
QT Interval, Day 7, 2 hours post-dose, n= 15369.9 ± 25.66
QT Interval, Day 7, 4 hours post-dose, n= 15384.1 ± 30.53
QT Interval, Day 9 post-dose, n= 15382.4 ± 26.55
QTcF Interval, Baseline, n= 16390.0 ± 13.48
QTcF Interval, Day 1, 2 hours, n= 16385.6 ± 15.44
QTcF Interval, Day 1, 4 hours post-dose, n= 16392.4 ± 15.95
QTcF Interval, Day 4, Pre-dose, n= 15395.0 ± 21.88
QTcF Interval, Day 4, 2 hours post-dose, n= 15388.3 ± 17.56
QTcF Interval, Day 4, 4 hours post-dose, n= 15393.4 ± 18.97
QTcF Interval, Day 7, Pre-dose, n= 15393.0 ± 18.42
QTcF Interval, Day 7, 2 hours post-dose, n= 15383.8 ± 16.19
QTcF Interval, Day 7, 4 hours post-dose, n= 15389.5 ± 18.06
QTcF Interval, Day 9 post-dose, n= 15396.8 ± 18.51
QTcB Interval, Baseline, n= 16395.7 ± 14.19
QTcB Interval, Day 1, 2 hours post-dose, n= 16396.4 ± 17.29
QTcB Interval, Day 1, 4 hours post-dose, n= 16400.4 ± 16.20
QTcB Interval, Day 4, Pre-dose, n= 15399.2 ± 25.96
QTcB Interval, Day 4, 2 hours post-dose, n= 15396.2 ± 16.01
QTcB Interval, Day 4, 4 hours post-dose, n= 15398.0 ± 17.53
QTcB Interval, Day 7, Pre-dose, n= 15398.3 ± 23.83
QTcB Interval, Day 7, 2 hours post-dose, n= 15390.5 ± 13.31
QTcB Interval, Day 7, 4 hours post-dose, n= 15391.9 ± 16.35
QTcB Interval, Day 9 post-dose, n= 15404.0 ± 20.62
SecondaryPeriod 1: Change From Baseline in Temperature

Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 2, 3, 4, 5 and 7
Reported as:
Mean · Degree Celsius
Period 1: Change From Baseline in Temperature
Degree CelsiusTAF/FTC
Day 2-0.16 ± 0.400
Day 3-0.15 ± 0.576
Day 4-0.09 ± 0.406
Day 5-0.15 ± 0.371
Day 7-0.24 ± 0.491
SecondaryPeriod 2: Change From Baseline in Temperature

Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 4, 7, 9, and 10
Reported as:
Mean · Degree Celsius
Period 2: Change From Baseline in Temperature
Degree CelsiusTAF/FTC+GSK3640254
Day 4-0.10 ± 0.344
Day 7-0.07 ± 0.337
Day 9-0.01 ± 0.386
Day 100.07 ± 0.320
SecondaryPeriod 1: Absolute Values of Temperature

Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.

Time frame:
Baseline and at Days 2, 3, 4, 5 and 7
Reported as:
Mean · Degree Celsius
Period 1: Absolute Values of Temperature
Degree CelsiusTAF/FTC
Baseline36.49 ± 0.298
Day 236.33 ± 0.342
Day 336.34 ± 0.456
Day 436.41 ± 0.431
Day 536.34 ± 0.360
Day 736.25 ± 0.407
SecondaryPeriod 2: Absolute Values of Temperature

Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.

Time frame:
Baseline and at Days 4, 7, 9, and 10
Reported as:
Mean · Degree Celsius
Period 2: Absolute Values of Temperature
Degree CelsiusTAF/FTC+GSK3640254
Baseline, n= 1636.49 ± 0.257
Day 4, n=1536.37 ± 0.348
Day 7, n=1536.40 ± 0.421
Day 9, n=1536.46 ± 0.378
Day 10, n=1536.53 ± 0.282
SecondaryPeriod 1: Change From Baseline in Pulse Rate

Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 2, 3, 4, 5 and 7
Reported as:
Mean · Beats per minute
Period 1: Change From Baseline in Pulse Rate
Beats per minuteTAF/FTC
Day 2-1.2 ± 9.77
Day 3-3.8 ± 9.94
Day 4-4.0 ± 9.67
Day 5-1.6 ± 10.47
Day 7-7.6 ± 7.83
SecondaryPeriod 2: Change From Baseline in Pulse Rate

Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 4, 7, 9, and 10
Reported as:
Mean · Beats per minute
Period 2: Change From Baseline in Pulse Rate
Beats per minuteTAF/FTC+GSK3640254
Day 42.4 ± 18.62
Day 71.9 ± 15.62
Day 9-0.3 ± 10.20
Day 109.5 ± 11.12
SecondaryPeriod 1: Absolute Values of Pulse Rate

Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.

Time frame:
Baseline and at Days 2, 3, 4, 5 and 7
Reported as:
Mean · Beats per minute
Period 1: Absolute Values of Pulse Rate
Beats per minuteTAF/FTC
Baseline73.9 ± 9.24
Day 272.8 ± 10.14
Day 370.1 ± 11.18
Day 469.9 ± 10.81
Day 572.3 ± 12.38
Day 766.3 ± 10.20
SecondaryPeriod 2: Absolute Values of Pulse Rate

Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.

Time frame:
Baseline and at Days 4, 7, 9, and 10
Reported as:
Mean · Beats per minute
Period 2: Absolute Values of Pulse Rate
Beats per minuteTAF/FTC+GSK3640254
Baseline, n= 1670.5 ± 11.33
Day 4, n=1571.9 ± 18.39
Day 7, n=1571.4 ± 14.73
Day 9, n=1569.2 ± 10.73
Day 10, n=1579.0 ± 12.45
SecondaryPeriod 1: Change From Baseline in Respiratory Rate

Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 2, 3, 4, 5 and 7
Reported as:
Mean · Breaths per minute
Period 1: Change From Baseline in Respiratory Rate
Breaths per minuteTAF/FTC
Day 2-1.5 ± 2.00
Day 3-0.5 ± 3.14
Day 4-0.5 ± 2.37
Day 51.3 ± 2.52
Day 70.6 ± 3.24
SecondaryPeriod 2: Change From Baseline in Respiratory Rate

Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 4, 7, 9, and 10
Reported as:
Mean · Breaths per minute
Period 2: Change From Baseline in Respiratory Rate
Breaths per minuteTAF/FTC+GSK3640254
Day 4-3.2 ± 3.61
Day 7-2.4 ± 2.85
Day 9-0.8 ± 2.11
Day 10-1.5 ± 2.33
SecondaryPeriod 1: Absolute Values of Respiratory Rate

Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.

Time frame:
Baseline and at Days 2, 3, 4, 5 and 7
Reported as:
Mean · Breaths per minute
Period 1: Absolute Values of Respiratory Rate
Breaths per minuteTAF/FTC
Baseline14.0 ± 1.63
Day 212.5 ± 1.37
Day 313.5 ± 2.48
Day 413.5 ± 2.00
Day 515.3 ± 2.05
Day 714.6 ± 2.70
SecondaryPeriod 2: Absolute Values of Respiratory Rate

Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.

Time frame:
Baseline and at Days 4, 7, 9, and 10
Reported as:
Mean · Breaths per minute
Period 2: Absolute Values of Respiratory Rate
Breaths per minuteTAF/FTC+GSK3640254
Baseline, n= 1615.6 ± 2.22
Day 4, n=1512.5 ± 2.67
Day 7, n=1513.3 ± 2.35
Day 9, n=1514.9 ± 1.49
Day 10, n=1514.3 ± 1.49
SecondaryPeriod 1: Change From Baseline in Blood Pressure

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 2, 3, 4, 5 and 7
Reported as:
Mean · Millimeters of mercury
Period 1: Change From Baseline in Blood Pressure
Millimeters of mercuryTAF/FTC
SBP, Day 21.4 ± 8.96
SBP, Day 3-1.8 ± 8.54
SBP, Day 4-2.7 ± 6.16
SBP, Day 5-2.3 ± 8.81
SBP, Day 70.8 ± 9.47
DBP, Day 20.1 ± 8.33
DBP, Day 3-1.6 ± 7.20
DBP, Day 40.1 ± 7.89
DBP, Day 5-1.4 ± 6.20
DBP, Day 72.9 ± 7.58
SecondaryPeriod 2: Change From Baseline in Blood Pressure

SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 4, 7, 9, and 10
Reported as:
Mean · Millimeters of mercury
Period 2: Change From Baseline in Blood Pressure
Millimeters of mercuryTAF/FTC+GSK3640254
SBP, Day 4-0.3 ± 5.07
SBP, Day 71.1 ± 8.95
SBP, Day 9-1.7 ± 6.91
SBP, Day 104.1 ± 7.79
DBP, Day 40.1 ± 4.96
DBP, Day 73.7 ± 5.70
DBP, Day 9-4.0 ± 5.26
DBP, Day 10-2.1 ± 8.18
SecondaryPeriod 1: Absolute Values of Blood Pressure

SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.

Time frame:
Baseline and at Days 2, 3, 4, 5 and 7
Reported as:
Mean · Millimeters of mercury
Period 1: Absolute Values of Blood Pressure
Millimeters of mercuryTAF/FTC
SBP, Baseline123.3 ± 8.27
SBP, Day 2124.7 ± 9.60
SBP, Day 3121.5 ± 7.70
SBP, Day 4120.6 ± 8.47
SBP, Day 5121.0 ± 6.95
SBP, Day 7124.1 ± 10.56
DBP, Baseline75.3 ± 5.22
DBP, Day 275.4 ± 9.08
DBP, Day 373.8 ± 5.69
DBP, Day 475.4 ± 10.42
DBP, Day 573.9 ± 5.46
DBP, Day 778.2 ± 7.57
SecondaryPeriod 2: Absolute Values of Blood Pressure

SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.

Time frame:
Baseline and at Days 4, 7, 9, and 10
Reported as:
Mean · Millimeters of mercury
Period 2: Absolute Values of Blood Pressure
Millimeters of mercuryTAF/FTC+GSK3640254
SBP, Baseline, n= 16120.4 ± 7.27
SBP, Day 4, n=15119.3 ± 7.03
SBP, Day 7, n=15120.8 ± 10.58
SBP, Day 9, n=15117.9 ± 7.42
SBP, Day 10, n=15123.7 ± 8.52
DBP, Baseline, n= 1674.4 ± 6.14
DBP, Day 4, n= 1574.3 ± 5.16
DBP, Day 7, n= 1577.9 ± 8.98
DBP, Day 9, n= 1570.3 ± 7.36
DBP, Day 10, n= 1572.1 ± 6.41
SecondaryPeriod 2: AUC (0-tau) of GSK3640254

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Reported as:
Geometric mean · Hours*nanogram per milliliter
Period 2: AUC (0-tau) of GSK3640254
Hours*nanogram per milliliterTAF/FTC+GSK3640254
Period 2: AUC (0-tau) of GSK364025424.53 ± 26.5
SecondaryPeriod 2: Cmax of GSK3640254

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Reported as:
Geometric mean · Nanogram per milliliter
Period 2: Cmax of GSK3640254
Nanogram per milliliterTAF/FTC+GSK3640254
Period 2: Cmax of GSK36402541.411 ± 26.4
SecondaryPeriod 2: Ctau of GSK3640254

Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 1 and 2 hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Reported as:
Geometric mean · Nanogram per milliliter
Period 2: Ctau of GSK3640254
Nanogram per milliliterTAF/FTC+GSK3640254
Period 2: Ctau of GSK36402540.7883 ± 30.3
SecondaryPeriod 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254

Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Reported as:
Median · Hours
Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254
HoursTAF/FTC+GSK3640254
Period 2: Time of Maximum Observed Concentration (Tmax) of GSK36402545.000 (2.50 to 8.00)
SecondaryPeriod 1: Tmax of TAF

Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Reported as:
Median · Hours
Period 1: Tmax of TAF
HoursTAF/FTC
Period 1: Tmax of TAF1.00 (0.50 to 2.00)
SecondaryPeriod 2: Tmax of TAF

Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Reported as:
Median · Hours
Period 2: Tmax of TAF
HoursTAF/FTC+GSK3640254
Period 2: Tmax of TAF1.000 (0.50 to 2.00)
SecondaryPeriod 1: Tmax of FTC

Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Reported as:
Median · Hours
Period 1: Tmax of FTC
HoursTAF/FTC
Period 1: Tmax of FTC1.500 (1.00 to 3.00)
SecondaryPeriod 2: Tmax of FTC

Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Reported as:
Median · Hours
Period 2: Tmax of FTC
HoursTAF/FTC+GSK3640254
Period 2: Tmax of FTC1.500 (1.00 to 3.08)
SecondaryPeriod 1: Tmax of TFV

Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Reported as:
Median · Hours
Period 1: Tmax of TFV
HoursTAF/FTC
Period 1: Tmax of TFV3.000 (1.50 to 4.00)
SecondaryPeriod 2: Tmax of TFV

Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.

Time frame:
Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Reported as:
Median · Hours
Period 2: Tmax of TFV
HoursTAF/FTC+GSK3640254
Period 2: Tmax of TFV3.000 (1.00 to 5.00)

Adverse events

Collected over Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TAF/FTC0/16 (0%)0/16 (0%)9/16 (56.3%)
TAF/FTC+GSK36402540/16 (0%)0/16 (0%)3/16 (18.8%)
Most frequent other events
Showing 10 of 16
Most frequent other events
EventTAF/FTCTAF/FTC+GSK3640254
Upper respiratory tract infectionInfections and infestations3/160/16
Rash pustularInfections and infestations2/160/16
NauseaGastrointestinal disorders2/160/16
ConjunctivitisInfections and infestations1/160/16
Abdominal discomfortGastrointestinal disorders1/160/16
VomitingGastrointestinal disorders1/160/16
Back painMusculoskeletal and connective tissue disorders1/160/16
Muscular weaknessMusculoskeletal and connective tissue disorders1/160/16
HeadacheNervous system disorders1/160/16
SomnolenceNervous system disorders0/161/16

Baseline characteristics

Age, Continuous
Age, Continuous(Years)TAF/FTC Followed by TAF/FTC+GSK3640254
Mean33.9 ± 9.67
Sex: Female, Male
Sex: Female, Male(Participants)TAF/FTC Followed by TAF/FTC+GSK3640254
Female0
Male16
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)TAF/FTC Followed by TAF/FTC+GSK3640254
American Indian or Alaska Native1
Asian: East Asian Heritage1
Black or African American7
Native Hawaiian or other pacific islander1
White:White/Caucasian/European Heritage6
08

Study locations

1 site
  • GSK Investigational Site
    Austin, Texas 78744, United States
09

References and documents

Publications

  • Pene Dumitrescu T, Joshi SR, Xu J, Zhan J, Johnson M, Butcher L, Zimmerman E, Webster L, Davidson AM, Lataillade M, Min S. A Phase I Evaluation of the Pharmacokinetics and Tolerability of the HIV-1 Maturation Inhibitor GSK3640254 and Tenofovir Alafenamide/Emtricitabine in Healthy Participants. Antimicrob Agents Chemother. 2021 May 18;65(6):e02173-20. doi: 10.1128/AAC.02173-20. Print 2021 May 18. PubMed 33753329 ↗

Study documents

  • Statistical analysis plan · Apr 29, 2019
  • Study protocol · Dec 27, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03836729
Lead sponsor
ViiV Healthcare
Responsible party
Sponsor
First posted
Feb 11, 2019
Start date
Feb 11, 2019
Primary completion
Mar 30, 2019
Completion
Apr 30, 2019
Results posted
Apr 2, 2020
Last update
Apr 21, 2020

Study contacts

GSK Clinical Trials
study director · ViiV Healthcare

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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