A Phase 1/2 interventional study of GSK2798745 and Placebo in Cough, sponsored by GlaxoSmithKline. Terminated at 8 sites in United Kingdom. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-10-02.
Sponsored by GlaxoSmithKline · Phase 1/2, Interventional, and Treatment
GSK2798745 is a potent and selective transient receptor potential vanilloid 4 (TRPV4) channel blocker being investigated for the treatment of chronic cough. This is a multi-center, randomized, placebo-controlled, double-blind, two-period crossover study with a purpose to evaluate efficacy and safety of GSK2798745. Each subject will have 2 treatment periods, and will be randomized to one of the following treatments in each period: A) Placebo matching to GSK2798745 once daily for 7 days. B) 4.8 milligrams (mg) GSK2798745 on Day 1, followed by 2.4 mg GSK2798745 once daily for 6 days. There will be a washout period of 14 to 21 days between the treatment periods. A maximum of 48 subjects will be enrolled in the study and the total duration of participation in the study will be maximum of 10 and a half weeks including follow-up visit.
142 studies on the registry are indexed under Chronic Cough; 39 are open to participants now.
This study's enrollment of 17 is below the median of 60 across 104 interventional studies indexed under Chronic Cough.
Browse Chronic Cough studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Compared within Chronic Cough, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cough. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive GSK2798745 matching placebo tablets (two tablets on Day 1 followed by one tablet once daily for 6 days), via oral route (treatment period of total 7 days). After a washout period of 14 to 21 days, subjects will then receive 4.8 mg (two tablets of 2.4 mg) GSK2798745 on Day 1, followed by 2.4 mg GSK2798745 tablets once daily for 6 days via oral route (treatment period of total 7 days).
Drug: GSK2798745 · Drug: Placebo
Subjects will receive 4.8 mg (two tablets of 2.4 mg) GSK2798745 on Day 1, followed by 2.4 mg GSK2798745 tablets once daily for 6 days via oral route (treatment period of total 7 days). After a washout period of 14 to 21 days, subjects will then receive GSK2798745 matching placebo tablets (two tablets on Day 1 followed by one tablet once daily for 6 days), via oral route (treatment period of total 7 days).
Drug: GSK2798745 · Drug: Placebo
GSK2798745 tablets will be available as white to almost white, round, film-coated tablets (micronized active pharmaceutical ingredient \[API\]) to be taken with a glass of water (approximately 240 mL).
Placebo tablets will be available as white to almost white, round, film-coated tablets to be taken with a glass of water (approximately 240 mL).
Total Cough Counts During Day Time Hours Following 7-days of Dosing
Coughs were monitored using the VitaloJAK cough monitor. The total cough counts during day-time (10 hours) was calculated from the time of the monitor being attached i.e. immediately after dosing on Day 7 to 10 hours past the time of monitoring. Total cough counts were log-transformed prior to analysis. A non-informative prior was used. Analysis was performed using a Bayesian mixed model adjusting for subject-level and period-adjusted baselines, treatment and period. Subject-level baseline is defined as the mean of the two period-specific baselines. Period-adjusted baseline is defined as the difference between the period-specific baseline and subject-level baseline for each period. Posterior median and 95% credible interval is reported. All Subjects Population included all randomized participants who took at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.
Time frame: Up to 10 hours post-dose on Day 7 of each treatment period
Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. 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, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment.
Time frame: Up to 45 days
Change From Baseline Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Amino Transferase (AST) and Creatinine Kinase (CK)
Blood samples were collected for the analysis of clinical chemistry parameters including ALP, ALT, AST and CK. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 8 of each treatment period
Change From Baseline Values for Clinical Chemistry Parameter: Direct Bilirubin, Total Bilirubin and Creatinine
Blood samples were collected for the analysis of clinical chemistry parameters including direct bilirubin, total bilirubin and creatinine. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 8 for each treatment period
Change From Baseline Values for Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Urea
Blood samples were collected for the analysis of clinical chemistry parameters including calcium, glucose, potassium, sodium and urea/blood urea nitrogen (BUN). Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 8 of each treatment period
Change From Baseline Values for Clinical Chemistry Parameter: Total Protein
Blood samples were collected for the analysis of clinical chemistry parameter total protein. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 8 of each treatment period
Number of Participants With Abnormal Values of Cardiac Troponin
Cardiac troponin values was measured in participants.
Time frame: Up to 45 days
Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell (WBC) Count
Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and WBC count. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 8 of each treatment period
Change From Baseline Values for Hematology Parameter: Hemoglobin
Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 8 for each treatment period
Change From Baseline Values for Hematology Parameter: Hematocrit
Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 8 of each treatment period
Change From Baseline Values for Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Blood samples were collected for the analysis of hematology parameter: MCH. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 8 for each treatment period
Change From Baseline Values for Hematology Parameter: Mean Corpuscular Volume (MCV)
Blood samples were collected for the analysis of hematology parameter: MCV. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 8 of each treatment period
Change From Baseline Values for Hematology Parameter: Red Blood Cell (RBC) Count
Blood samples were collected for the analysis of hematology parameter: RBC count. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 8 for each treatment period
Change From Baseline Values for Hematology Parameter: Reticulocytes
Blood samples were collected for the analysis of hematology parameter: reticulocytes. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 8 for each treatment period
Number of Participants With Abnormal Urinalysis Data
Urine samples were collected for analysis of urinalysis data by dipstick method. Number of participants with abnormal urinalysis data has been presented. Abnormality was defined as value of potential clinical importance (PCI). PCI was flagged when a result changed from negative on Day 1 (pre-dose) to positive on Day 8.
Time frame: Up to Day 8
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Blood pressure was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (pre-dose on Day 1) and Day 8 of each treatment period
Change From Baseline in Temperature
Temperature was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (pre-dose on Day 1) and Day 8 of each treatment period
Change From Baseline in Heart Rate
Heart rate was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (pre-dose on Day 1) and Day 8 of each treatment period
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Twelve-lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Number of participants with abnormal-clinically significant and abnormal-not clinically significant values has been presented.
Time frame: Baseline (pre-dose on Day 1) and Day 8 of each treatment period
Study was conducted at 4 centers in the United Kingdom. Participants who met eligibility criteria entered a 2-period crossover study. Participants were randomized to either placebo or GSK2798745 in each Treatment Period (each 7 days, with a 14-21 day washout). Total duration of participation was 10.5 weeks. Study terminated on grounds of futility
| Milestone | Placebo/GSK2798745 | GSK2798745/Placebo |
|---|---|---|
| Started | 9 | 8 |
| Completed | 9 | 8 |
| Not completed | 0 | 0 |
| Milestone | Placebo/GSK2798745 | GSK2798745/Placebo |
|---|---|---|
| Started | 9 | 8 |
| Completed | 8 | 8 |
| Not completed | 1 | 0 |
| Withdrew: Sponsor terminated study treatment | 1 | 0 |
| Milestone | Placebo/GSK2798745 | GSK2798745/Placebo |
|---|---|---|
| Started | 8 | 8 |
| Completed | 7 | 8 |
| Not completed | 1 | 0 |
| Withdrew: Study closed/terminated | 1 | 0 |
Coughs were monitored using the VitaloJAK cough monitor. The total cough counts during day-time (10 hours) was calculated from the time of the monitor being attached i.e. immediately after dosing on Day 7 to 10 hours past the time of monitoring. Total cough counts were log-transformed prior to analysis. A non-informative prior was used. Analysis was performed using a Bayesian mixed model adjusting for subject-level and period-adjusted baselines, treatment and period. Subject-level baseline is defined as the mean of the two period-specific baselines. Period-adjusted baseline is defined as the difference between the period-specific baseline and subject-level baseline for each period. Posterior median and 95% credible interval is reported. All Subjects Population included all randomized participants who took at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.
| Cough counts | Placebo | GSK2798745 |
|---|---|---|
| Total Cough Counts During Day Time Hours Following 7-days of Dosing | 180.570 (137.852 to 235.446) | 241.105 (181.383 to 320.600) |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. 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, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment.
| Participants | Placebo | GSK2798745 |
|---|---|---|
| Any AE | 9 | 11 |
| Any SAE | 0 | 0 |
Blood samples were collected for the analysis of clinical chemistry parameters including ALP, ALT, AST and CK. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
| International units per liter | Placebo | GSK2798745 |
|---|---|---|
| ALP | 1.8 ± 9.28 | -3.1 ± 6.75 |
| ALT | 0.2 ± 2.31 | -0.2 ± 5.32 |
| AST | -0.6 ± 3.69 | -0.5 ± 2.65 |
| CK | -3.0 ± 21.71 | -12.1 ± 52.12 |
Blood samples were collected for the analysis of clinical chemistry parameters including direct bilirubin, total bilirubin and creatinine. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
| Micromoles per liter | Placebo | GSK2798745 |
|---|---|---|
| Direct bilirubin | 0.1 ± 1.11 | 0.0 ± 0.78 |
| Total bilirubin | -0.4 ± 3.41 | -0.4 ± 3.25 |
| Creatinine | 0.31 ± 6.458 | 1.70 ± 4.031 |
Blood samples were collected for the analysis of clinical chemistry parameters including calcium, glucose, potassium, sodium and urea/blood urea nitrogen (BUN). Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
| Millimoles per liter | Placebo | GSK2798745 |
|---|---|---|
| Calcium | 0.011 ± 0.0588 | 0.019 ± 0.0782 |
| Glucose | -0.22 ± 1.234 | -0.06 ± 0.956 |
| Potassium | 0.09 ± 0.299 | 0.09 ± 0.270 |
| Sodium | 0.2 ± 1.44 | -0.1 ± 1.46 |
| Urea | 0.18 ± 0.683 | -0.36 ± 0.908 |
Blood samples were collected for the analysis of clinical chemistry parameter total protein. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
| Grams per liter | Placebo | GSK2798745 |
|---|---|---|
| Change From Baseline Values for Clinical Chemistry Parameter: Total Protein | 1.2 ± 2.65 | 0.9 ± 2.53 |
Cardiac troponin values was measured in participants.
| Participants | Placebo | GSK2798745 |
|---|---|---|
| Number of Participants With Abnormal Values of Cardiac Troponin | NA | NA |
Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and WBC count. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
| Giga units per liter | Placebo | GSK2798745 |
|---|---|---|
| Basophils | 0.005 ± 0.0250 | -0.005 ± 0.0316 |
| Eosinophils | -0.005 ± 0.0400 | -0.007 ± 0.0758 |
| Lymphocytes | 0.019 ± 0.3065 | -0.002 ± 0.2608 |
| Monocytes | -0.012 ± 0.1110 | 0.027 ± 0.1012 |
| Total neutrophils | 0.186 ± 0.5817 | 0.064 ± 1.0102 |
| Platelet count | 6.8 ± 13.57 | 6.9 ± 19.76 |
| WBC count | 0.20 ± 0.614 | 0.09 ± 1.276 |
Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
| Grams per liter | Placebo | GSK2798745 |
|---|---|---|
| Change From Baseline Values for Hematology Parameter: Hemoglobin | 0.5 ± 2.29 | 0.5 ± 3.52 |
Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
| Percentage of red blood cells in blood | Placebo | GSK2798745 |
|---|---|---|
| Change From Baseline Values for Hematology Parameter: Hematocrit | 0.0020 ± 0.01009 | 0.0029 ± 0.00979 |
Blood samples were collected for the analysis of hematology parameter: MCH. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
| Picograms | Placebo | GSK2798745 |
|---|---|---|
| Change From Baseline Values for Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | -0.07 ± 0.377 | -0.09 ± 0.442 |
Blood samples were collected for the analysis of hematology parameter: MCV. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
| Femtoliters | Placebo | GSK2798745 |
|---|---|---|
| Change From Baseline Values for Hematology Parameter: Mean Corpuscular Volume (MCV) | -0.1 ± 2.01 | -0.1 ± 1.53 |
Blood samples were collected for the analysis of hematology parameter: RBC count. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
| Tera units per liter | Placebo | GSK2798745 |
|---|---|---|
| Change From Baseline Values for Hematology Parameter: Red Blood Cell (RBC) Count | 0.04 ± 0.112 | 0.03 ± 0.103 |
Blood samples were collected for the analysis of hematology parameter: reticulocytes. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
| Percentage of reticulocytes in blood | Placebo | GSK2798745 |
|---|---|---|
| Change From Baseline Values for Hematology Parameter: Reticulocytes | -0.0002 ± 0.00300 | -0.0002 ± 0.00260 |
Urine samples were collected for analysis of urinalysis data by dipstick method. Number of participants with abnormal urinalysis data has been presented. Abnormality was defined as value of potential clinical importance (PCI). PCI was flagged when a result changed from negative on Day 1 (pre-dose) to positive on Day 8.
| Participants | Placebo | GSK2798745 |
|---|---|---|
| Number of Participants With Abnormal Urinalysis Data | 4 | 2 |
Blood pressure was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
| Millimeters of mercury | Placebo | GSK2798745 |
|---|---|---|
| DBP | -0.2 ± 8.59 | -0.5 ± 13.07 |
| SBP | 1.6 ± 12.65 | 0.9 ± 20.10 |
Temperature was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
| Degrees Celsius | Placebo | GSK2798745 |
|---|---|---|
| Change From Baseline in Temperature | 0.02 ± 0.635 | -0.05 ± 0.331 |
Heart rate was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
| Beats per minute | Placebo | GSK2798745 |
|---|---|---|
| Change From Baseline in Heart Rate | 0.6 ± 8.65 | -1.3 ± 12.09 |
Twelve-lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Number of participants with abnormal-clinically significant and abnormal-not clinically significant values has been presented.
| Participants | Placebo | GSK2798745 |
|---|---|---|
| Day 1 pre-dose, not clinically significant,n=17,16 | 2 | 1 |
| Day 1 pre-dose, clinically significant, n=17,16 | 0 | 0 |
| Day 8, not clinically significant, n=17,15 | 2 | 1 |
| Day 8, clinically significant, n=17,15 | 0 | 1 |
Collected over AEs and SAEs were collected from the start of the treatment up to 45 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/17 (0%) | 0/17 (0%) | 9/17 (52.9%) |
| GSK2798745 | 0/16 (0%) | 0/16 (0%) | 11/16 (68.8%) |
| Event | Placebo | GSK2798745 |
|---|---|---|
| HeadacheNervous system disorders | 3/17 | 7/16 |
| FatigueGeneral disorders | 1/17 | 2/16 |
| DiarrhoeaGastrointestinal disorders | 2/17 | 1/16 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 2/17 | 0/16 |
| VomitingGastrointestinal disorders | 1/17 | 1/16 |
| GastroenteritisGastrointestinal disorders | 0/17 | 1/16 |
| Irritable bowel syndromeGastrointestinal disorders | 0/17 | 1/16 |
| ToothacheGastrointestinal disorders | 0/17 | 1/16 |
| Ear pruritusEar and labyrinth disorders | 0/17 | 1/16 |
| HypoacusisEar and labyrinth disorders | 0/17 | 1/16 |
| Age, Continuous(Years) | All Study Participants |
|---|---|
| Mean | 61.0 ± 9.85 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 15 |
| Male | 2 |
| Race/Ethnicity, Customized(Participants) | All Study Participants |
|---|---|
| Asian-Japanese/East Asian (EA)/South EA Heritage | 1 |
| White | 16 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from Apr 2018 to primary completion in Oct 2018, 6 months.
Results were first posted in Oct 2019, 11 months after primary completion.
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This study is terminated, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: GSK2798745