Trial Outcomes & Findings for Study to Evaluate the Effect of GSK3640254 on the Pharmacokinetics of Tenofovir Alafenamide/Emtricitabine (NCT NCT03836729)
NCT ID: NCT03836729
Last Updated: 2020-04-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
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
Results posted on
2020-04-21
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).
A total of 16 participants were enrolled in the study.
Participant milestones
| Measure |
TAF/FTC Followed by TAF/FTC+GSK3640254
Participants in Period 1 received 25 milligram (mg) of TAF and 200 mg of FTC once daily (QD) on Days 1 through 14. In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|
|
Treatment Period 1 (Up to Day 14)
STARTED
|
16
|
|
Treatment Period 1 (Up to Day 14)
COMPLETED
|
16
|
|
Treatment Period 1 (Up to Day 14)
NOT COMPLETED
|
0
|
|
Treatment Period 2 (Up to Day 7)
STARTED
|
16
|
|
Treatment Period 2 (Up to Day 7)
COMPLETED
|
15
|
|
Treatment Period 2 (Up to Day 7)
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
TAF/FTC Followed by TAF/FTC+GSK3640254
Participants in Period 1 received 25 milligram (mg) of TAF and 200 mg of FTC once daily (QD) on Days 1 through 14. In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|
|
Treatment Period 2 (Up to Day 7)
Adverse Event
|
1
|
Baseline Characteristics
Study to Evaluate the Effect of GSK3640254 on the Pharmacokinetics of Tenofovir Alafenamide/Emtricitabine
Baseline characteristics by cohort
| Measure |
TAF/FTC Followed by TAF/FTC+GSK3640254
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|
|
Age, Continuous
|
33.9 Years
STANDARD_DEVIATION 9.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian: East Asian Heritage
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other pacific islander
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White:White/Caucasian/European Heritage
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 14Population: PK Parameter Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
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
|
250.4 Hours*nanogram per milliliter
Geometric Coefficient of Variation 58.2
|
—
|
PRIMARY outcome
Timeframe: 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 7Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=15 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: AUC (0-tau) of TAF
|
215.4 Hours*nanogram per milliliter
Geometric Coefficient of Variation 36.3
|
—
|
PRIMARY outcome
Timeframe: 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 14Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Maximum Observed Concentration (Cmax) of TAF
|
203.4 Nanogram per milliliter
Geometric Coefficient of Variation 56.1
|
—
|
PRIMARY outcome
Timeframe: 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 7Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=15 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Cmax of TAF
|
175.1 Nanogram per milliliter
Geometric Coefficient of Variation 44.4
|
—
|
PRIMARY outcome
Timeframe: 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 14Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: AUC (0-tau) of FTC
|
9787.5 Hours*nanogram per milliliter
Geometric Coefficient of Variation 15.5
|
—
|
PRIMARY outcome
Timeframe: 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 7Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=15 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: AUC (0-tau) of FTC
|
9421.0 Hours*nanogram per milliliter
Geometric Coefficient of Variation 14.4
|
—
|
PRIMARY outcome
Timeframe: 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 14Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1:Cmax of FTC
|
1811 Nanogram per milliliter
Geometric Coefficient of Variation 15.9
|
—
|
PRIMARY outcome
Timeframe: 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 7Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=15 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2:Cmax of FTC
|
1701 Nanogram per milliliter
Geometric Coefficient of Variation 20.9
|
—
|
PRIMARY outcome
Timeframe: 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 14Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of FTC
|
71.81 Nanogram per milliliter
Geometric Coefficient of Variation 25.5
|
—
|
PRIMARY outcome
Timeframe: 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 7Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=15 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Ctau of FTC
|
82.92 Nanogram per milliliter
Geometric Coefficient of Variation 29.1
|
—
|
PRIMARY outcome
Timeframe: 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 14Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: AUC (0-tau) of Tenofovir (TFV)
|
221.9 Hours*nanogram per milliliter
Geometric Coefficient of Variation 18.3
|
—
|
PRIMARY outcome
Timeframe: 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 7Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=15 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: AUC (0-tau) of TFV
|
229.1 Hours*nanogram per milliliter
Geometric Coefficient of Variation 21.5
|
—
|
PRIMARY outcome
Timeframe: 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 14Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Cmax of TFV
|
13.14 Nanogram per milliliter
Geometric Coefficient of Variation 17.8
|
—
|
PRIMARY outcome
Timeframe: 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 7Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=15 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Cmax of TFV
|
13.30 Nanogram per milliliter
Geometric Coefficient of Variation 20.8
|
—
|
PRIMARY outcome
Timeframe: 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 14Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Ctau of TFV
|
7.688 Nanogram per milliliter
Geometric Coefficient of Variation 20.4
|
—
|
PRIMARY outcome
Timeframe: 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 7Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=15 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Ctau of TFV
|
8.244 Nanogram per milliliter
Geometric Coefficient of Variation 22.9
|
—
|
SECONDARY outcome
Timeframe: Up to Day 24Population: Safety Population included all participants who received at least 1 dose of study medication.
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
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
n=15 Participants
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE)
Non-SAEs
|
9 Participants
|
3 Participants
|
|
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE)
SAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, and 14Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Basophils, Period 1 Day 7
|
-0.005 Giga cells per liter
Standard Deviation 0.0167
|
—
|
|
Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Basophils, Period 1 Day 14
|
-0.006 Giga cells per liter
Standard Deviation 0.0260
|
—
|
|
Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Eosinophils, Period 1 Day 7
|
-0.021 Giga cells per liter
Standard Deviation 0.0795
|
—
|
|
Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Eosinophils, Period 1 Day 14
|
-0.020 Giga cells per liter
Standard Deviation 0.1531
|
—
|
|
Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Monocytes, Period 1 Day 7
|
0.014 Giga cells per liter
Standard Deviation 0.1808
|
—
|
|
Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Monocytes, Period 1 Day 14
|
0.049 Giga cells per liter
Standard Deviation 0.2718
|
—
|
|
Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Leukocytes, Period 1 Day 7
|
-0.08 Giga cells per liter
Standard Deviation 1.795
|
—
|
|
Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Leukocytes, Period 1 Day 14
|
0.27 Giga cells per liter
Standard Deviation 2.191
|
—
|
|
Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Lymphocytes, Period 1 Day 7
|
-0.246 Giga cells per liter
Standard Deviation 0.3089
|
—
|
|
Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Lymphocytes, Period 1 Day 14
|
-0.262 Giga cells per liter
Standard Deviation 0.4138
|
—
|
|
Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Neutrophils, Period 1 Day 7
|
0.188 Giga cells per liter
Standard Deviation 1.5473
|
—
|
|
Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Neutrophils, Period 1 Day 14
|
0.513 Giga cells per liter
Standard Deviation 1.7986
|
—
|
|
Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Platelets, Period 1 Day 7
|
3.3 Giga cells per liter
Standard Deviation 21.23
|
—
|
|
Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Platelets, Period 1 Day 14
|
21.8 Giga cells per liter
Standard Deviation 35.37
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Basophils, Period 2 Day 3, n= 15
|
-0.004 Giga cells per liter
Standard Deviation 0.0196
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Basophils, Period 2 Day 7, n= 15
|
-0.002 Giga cells per liter
Standard Deviation 0.0204
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Basophils, Period 2 Day 9, n= 15
|
0.003 Giga cells per liter
Standard Deviation 0.0150
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Eosinophils, Period 2 Day 3, n=15
|
-0.023 Giga cells per liter
Standard Deviation 0.0811
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Eosinophils, Period 2 Day 7, n=15
|
-0.039 Giga cells per liter
Standard Deviation 0.1058
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Eosinophils, Period 2 Day 9, n=16
|
-0.043 Giga cells per liter
Standard Deviation 0.1093
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Monocytes, Period 2 Day 3, n= 16
|
-0.053 Giga cells per liter
Standard Deviation 0.1895
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Monocytes, Period 2 Day 7, n= 15
|
-0.077 Giga cells per liter
Standard Deviation 0.1709
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Monocytes, Period 2 Day 9, n= 15
|
-0.104 Giga cells per liter
Standard Deviation 0.1672
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Leukocytes, Period 2 Day 3, n= 16
|
-1.06 Giga cells per liter
Standard Deviation 1.188
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Leukocytes, Period 2 Day 7, n= 15
|
-0.61 Giga cells per liter
Standard Deviation 1.050
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Leukocytes, Period 2 Day 9, n= 15
|
-0.49 Giga cells per liter
Standard Deviation 1.193
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Lymphocytes, Period 2 Day 3, n= 16
|
-0.158 Giga cells per liter
Standard Deviation 0.2296
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Lymphocytes, Period 2 Day 7, n= 15
|
-0.105 Giga cells per liter
Standard Deviation 0.2306
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Lymphocytes, Period 2 Day 9, n= 15
|
-0.111 Giga cells per liter
Standard Deviation 0.2728
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Neutrophils, Period 2 Day 3, n= 16
|
-0.868 Giga cells per liter
Standard Deviation 0.9597
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Neutrophils, Period 2 Day 7, n= 15
|
-0.417 Giga cells per liter
Standard Deviation 0.9069
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Neutrophils, Period 2 Day 9, n= 15
|
-0.282 Giga cells per liter
Standard Deviation 1.0161
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Platelets, Period 2 Day 3, n= 16
|
9.2 Giga cells per liter
Standard Deviation 20.41
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Platelets, Period 2 Day 7, n= 15
|
19.8 Giga cells per liter
Standard Deviation 43.02
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Platelets, Period 2 Day 9, n= 15
|
16.2 Giga cells per liter
Standard Deviation 38.11
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, and 14Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Basophils, Period 1 Baseline
|
0.046 Giga cells per liter
Standard Deviation 0.0216
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Basophils, Period 1 Day 7
|
0.041 Giga cells per liter
Standard Deviation 0.0189
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Basophils, Period 1 Day 14
|
0.040 Giga cells per liter
Standard Deviation 0.0256
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Eosinophils, Period 1 Baseline
|
0.225 Giga cells per liter
Standard Deviation 0.1918
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Eosinophils, Period 1 Day 7
|
0.204 Giga cells per liter
Standard Deviation 0.1737
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Eosinophils, Period 1 Day 14
|
0.205 Giga cells per liter
Standard Deviation 0.1766
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Monocytes, Period 1 Baseline
|
0.522 Giga cells per liter
Standard Deviation 0.1147
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Monocytes, Period 1 Day 7
|
0.536 Giga cells per liter
Standard Deviation 0.2063
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Monocytes, Period 1 Day 14
|
0.571 Giga cells per liter
Standard Deviation 0.2830
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Leukocytes, Period 1 Baseline
|
6.18 Giga cells per liter
Standard Deviation 1.336
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Leukocytes, Period 1 Day 7
|
6.10 Giga cells per liter
Standard Deviation 2.024
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Leukocytes, Period 1 Day 14
|
6.45 Giga cells per liter
Standard Deviation 2.231
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Lymphocytes, Period 1 Baseline
|
1.945 Giga cells per liter
Standard Deviation 0.7419
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Lymphocytes, Period 1 Day 7
|
1.699 Giga cells per liter
Standard Deviation 0.5822
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Lymphocytes, Period 1 Day 14
|
1.683 Giga cells per liter
Standard Deviation 0.4988
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Neutrophils, Period 1 Baseline
|
3.441 Giga cells per liter
Standard Deviation 0.9719
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Neutrophils, Period 1 Day 7
|
3.628 Giga cells per liter
Standard Deviation 1.9503
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Neutrophils, Period 1 Day 14
|
3.954 Giga cells per liter
Standard Deviation 1.9141
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Platelets, Period 1 Baseline
|
253.3 Giga cells per liter
Standard Deviation 49.81
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Platelets, Period 1 Day 7
|
256.6 Giga cells per liter
Standard Deviation 49.72
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Platelets, Period 1 Day 14
|
275.1 Giga cells per liter
Standard Deviation 53.39
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Basophils, Period 2 Baseline, n= 16
|
0.040 Giga cells per liter
Standard Deviation 0.0256
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Basophils, Period 2 Day 3, n= 15
|
0.036 Giga cells per liter
Standard Deviation 0.0182
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Basophils, Period 2 Day 7, n= 15
|
0.038 Giga cells per liter
Standard Deviation 0.0152
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Basophils, Period 2 Day 9, n= 15
|
0.043 Giga cells per liter
Standard Deviation 0.0232
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Eosinophils, Period 2 Baseline, n= 16
|
0.208 Giga cells per liter
Standard Deviation 0.1764
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Eosinophils, Period 2 Day 3, n= 15
|
0.185 Giga cells per liter
Standard Deviation 0.1533
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Eosinophils, Period 2 Day 7, n= 15
|
0.157 Giga cells per liter
Standard Deviation 0.1405
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Eosinophils, Period 2 Day 9, n= 16
|
0.153 Giga cells per liter
Standard Deviation 0.1384
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Monocytes, Period 2 Baseline, n= 16
|
0.545 Giga cells per liter
Standard Deviation 0.2127
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Monocytes, Period 2 Day 3, n= 16
|
0.492 Giga cells per liter
Standard Deviation 0.1975
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Monocytes, Period 2 Day 7, n= 15
|
0.448 Giga cells per liter
Standard Deviation 0.1472
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Monocytes, Period 2 Day 9, n= 15
|
0.421 Giga cells per liter
Standard Deviation 0.1212
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Leukocytes, Period 2 Baseline, n= 16
|
6.20 Giga cells per liter
Standard Deviation 1.752
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Leukocytes, Period 2 Day 3, n= 16
|
5.14 Giga cells per liter
Standard Deviation 1.035
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Leukocytes, Period 2 Day 7, n= 15
|
5.39 Giga cells per liter
Standard Deviation 1.311
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Leukocytes, Period 2 Day 9, n= 15
|
5.51 Giga cells per liter
Standard Deviation 1.415
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Lymphocytes, Period 2 Baseline, n= 16
|
1.718 Giga cells per liter
Standard Deviation 0.4814
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Lymphocytes, Period 2 Day 3, n= 16
|
1.560 Giga cells per liter
Standard Deviation 0.3786
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Lymphocytes, Period 2 Day 7, n= 15
|
1.570 Giga cells per liter
Standard Deviation 0.4116
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Lymphocytes, Period 2 Day 9, n= 15
|
1.563 Giga cells per liter
Standard Deviation 0.4236
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Neutrophils, Period 2 Baseline, n= 16
|
3.724 Giga cells per liter
Standard Deviation 1.3787
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Neutrophils, Period 2 Day 3, n= 16
|
2.857 Giga cells per liter
Standard Deviation 0.8106
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Neutrophils, Period 2 Day 7, n= 15
|
3.189 Giga cells per liter
Standard Deviation 1.0515
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Neutrophils, Period 2 Day 9, n= 15
|
3.324 Giga cells per liter
Standard Deviation 1.1988
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Platelets, Period 2 Baseline, n= 16
|
274.3 Giga cells per liter
Standard Deviation 51.10
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Platelets, Period 2 Day 3, n= 16
|
283.4 Giga cells per liter
Standard Deviation 54.62
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Platelets, Period 2 Day 7, n= 15
|
294.0 Giga cells per liter
Standard Deviation 54.62
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Platelets, Period 2 Day 9, n= 15
|
290.4 Giga cells per liter
Standard Deviation 73.92
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Change From Baseline in Hematology Parameter of Hematocrit
Day 7
|
0.0121 Proportion of red blood cells in blood
Standard Deviation 0.01389
|
—
|
|
Period 1: Change From Baseline in Hematology Parameter of Hematocrit
Day 14
|
0.0189 Proportion of red blood cells in blood
Standard Deviation 0.01304
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Change From Baseline in Hematology Parameter of Hematocrit
Day 3, n= 16
|
-0.0147 Proportion of red blood cells in blood
Standard Deviation 0.00982
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Hematocrit
Day 7, n= 15
|
-0.0007 Proportion of red blood cells in blood
Standard Deviation 0.01369
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Hematocrit
Day 9, n= 15
|
-0.0204 Proportion of red blood cells in blood
Standard Deviation 0.01371
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
Blood samples were collected at indicated time points for analysis for hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Absolute Values of the Hematology Parameter: Hematocrit
Baseline
|
0.4264 Proportion of red blood cells in blood
Standard Deviation 0.01891
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter: Hematocrit
Day 7
|
0.4384 Proportion of red blood cells in blood
Standard Deviation 0.02358
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter: Hematocrit
Day 14
|
0.4453 Proportion of red blood cells in blood
Standard Deviation 0.01997
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Absolute Values of the Hematology Parameter: Hematocrit
Baseline, n= 16
|
0.4453 Proportion of red blood cells in blood
Standard Deviation 0.01997
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter: Hematocrit
Day 3, n= 16
|
0.4306 Proportion of red blood cells in blood
Standard Deviation 0.01780
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter: Hematocrit
Day 7, n= 15
|
0.4444 Proportion of red blood cells in blood
Standard Deviation 0.02234
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter: Hematocrit
Day 9, n= 15
|
0.4247 Proportion of red blood cells in blood
Standard Deviation 0.01518
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Change From Baseline in Hematology Parameter of Hemoglobin
Day 7
|
6.1 Grams per liter
Standard Deviation 4.51
|
—
|
|
Period 1: Change From Baseline in Hematology Parameter of Hemoglobin
Day 14
|
8.4 Grams per liter
Standard Deviation 3.98
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Change From Baseline in Hematology Parameter of Hemoglobin
Day 3, n= 16
|
-3.9 Grams per liter
Standard Deviation 3.51
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Hemoglobin
Day 7, n= 15
|
-1.1 Grams per liter
Standard Deviation 4.58
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Hemoglobin
Day 9, n= 15
|
-6.4 Grams per liter
Standard Deviation 5.55
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Absolute Values of the Hematology Parameter: Hemoglobin
Baseline
|
142.0 Grams per liter
Standard Deviation 6.70
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter: Hemoglobin
Day 7
|
148.1 Grams per liter
Standard Deviation 8.11
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter: Hemoglobin
Day 14
|
150.4 Grams per liter
Standard Deviation 7.45
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Absolute Values of the Hematology Parameter: Hemoglobin
Baseline, n= 16
|
150.4 Grams per liter
Standard Deviation 7.45
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter: Hemoglobin
Day 3, n= 16
|
146.4 Grams per liter
Standard Deviation 6.37
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter: Hemoglobin
Day 7, n= 15
|
149.1 Grams per liter
Standard Deviation 7.26
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter: Hemoglobin
Day 9, n= 15
|
143.9 Grams per liter
Standard Deviation 5.19
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH)
Day 7
|
0.13 Picograms
Standard Deviation 0.272
|
—
|
|
Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH)
Day 14
|
0.36 Picograms
Standard Deviation 0.276
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Change From Baseline in Hematology Parameter of MCH
Day 3, n= 16
|
-0.11 Picograms
Standard Deviation 0.205
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of MCH
Day 7, n= 15
|
-0.21 Picograms
Standard Deviation 0.203
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of MCH
Day 9, n= 15
|
-0.17 Picograms
Standard Deviation 0.253
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
Blood samples were collected at indicated time-points for analysis for hematology parameter like MCH. Baseline was defined as Day -1 for Period 1.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Absolute Values of the Hematology Parameter: MCH
Baseline
|
28.63 Picograms
Standard Deviation 1.780
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter: MCH
Day 7
|
28.75 Picograms
Standard Deviation 1.687
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter: MCH
Day 14
|
28.98 Picograms
Standard Deviation 1.690
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Absolute Values of the Hematology Parameter: MCH
Baseline, n= 16
|
28.98 Picograms
Standard Deviation 1.690
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter: MCH
Day 3, n= 16
|
28.88 Picograms
Standard Deviation 1.699
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter: MCH
Day 7, n= 15
|
28.83 Picograms
Standard Deviation 1.630
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter: MCH
Day 9, n= 15
|
28.87 Picograms
Standard Deviation 1.702
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV)
Day 7
|
-0.83 Femtoliters
Standard Deviation 0.620
|
—
|
|
Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV)
Day 14
|
-0.07 Femtoliters
Standard Deviation 0.712
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Change From Baseline in Hematology Parameter of MCV
Day 3, n= 16
|
-1.02 Femtoliters
Standard Deviation 0.483
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of MCV
Day 7, n= 15
|
-0.17 Femtoliters
Standard Deviation 0.472
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of MCV
Day 9, n= 15
|
-0.82 Femtoliters
Standard Deviation 0.499
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Absolute Values of the Hematology Parameter: MCV
Baseline
|
85.92 Femtoliters
Standard Deviation 4.690
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter: MCV
Day 7
|
85.09 Femtoliters
Standard Deviation 4.504
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter: MCV
Day 14
|
85.85 Femtoliters
Standard Deviation 4.492
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Absolute Values of the Hematology Parameter: MCV
Baseline, n= 16
|
85.85 Femtoliters
Standard Deviation 4.492
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter: MCV
Day 3, n= 16
|
84.83 Femtoliters
Standard Deviation 4.490
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter: MCV
Day 7, n= 15
|
85.85 Femtoliters
Standard Deviation 4.491
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter: MCV
Day 9, n= 15
|
85.20 Femtoliters
Standard Deviation 4.601
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Change From Baseline in Hematology Parameter of Erythrocytes
Day 7
|
0.189 Trillion cells per liter
Standard Deviation 0.1485
|
—
|
|
Period 1: Change From Baseline in Hematology Parameter of Erythrocytes
Day 14
|
0.226 Trillion cells per liter
Standard Deviation 0.1360
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Change From Baseline in Hematology Parameter of Erythrocytes
Day 3, n= 16
|
-0.113 Trillion cells per liter
Standard Deviation 0.1123
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Erythrocytes
Day 7, n= 15
|
0.000 Trillion cells per liter
Standard Deviation 0.1466
|
—
|
|
Period 2: Change From Baseline in Hematology Parameter of Erythrocytes
Day 9, n= 15
|
-0.189 Trillion cells per liter
Standard Deviation 0.1697
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Absolute Values of the Hematology Parameter: Erythrocytes
Baseline
|
4.977 Trillion cells per liter
Standard Deviation 0.3351
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter: Erythrocytes
Day 7
|
5.166 Trillion cells per liter
Standard Deviation 0.3679
|
—
|
|
Period 1: Absolute Values of the Hematology Parameter: Erythrocytes
Day 14
|
5.203 Trillion cells per liter
Standard Deviation 0.3604
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Absolute Values of the Hematology Parameter: Erythrocytes
Baseline, n= 16
|
5.203 Trillion cells per liter
Standard Deviation 0.3604
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter: Erythrocytes
Day 3, n= 16
|
5.090 Trillion cells per liter
Standard Deviation 0.3395
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter: Erythrocytes
Day 7, n= 15
|
5.190 Trillion cells per liter
Standard Deviation 0.4087
|
—
|
|
Period 2: Absolute Values of the Hematology Parameter: Erythrocytes
Day 9, n= 15
|
5.001 Trillion cells per liter
Standard Deviation 0.3446
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
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
Glucose, Day 7
|
-0.160 Millimoles per Liter
Standard Deviation 0.3793
|
—
|
|
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
Glucose, Day 14
|
-0.320 Millimoles per Liter
Standard Deviation 0.3432
|
—
|
|
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
Cholesterol, Day 7
|
-0.004 Millimoles per Liter
Standard Deviation 0.3735
|
—
|
|
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
Cholesterol, Day 14
|
-0.389 Millimoles per Liter
Standard Deviation 0.3533
|
—
|
|
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
Anion gap, Day 7
|
1.9 Millimoles per Liter
Standard Deviation 2.08
|
—
|
|
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
Anion gap, Day 14
|
2.2 Millimoles per Liter
Standard Deviation 1.42
|
—
|
|
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
Calcium, Day 7
|
0.028 Millimoles per Liter
Standard Deviation 0.0780
|
—
|
|
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
Calcium, Day 14
|
0.028 Millimoles per Liter
Standard Deviation 0.0556
|
—
|
|
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
CO2, Day 7
|
-1.6 Millimoles per Liter
Standard Deviation 1.93
|
—
|
|
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
CO2, Day 14
|
-0.9 Millimoles per Liter
Standard Deviation 1.20
|
—
|
|
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
Chloride, Day 7
|
-1.1 Millimoles per Liter
Standard Deviation 1.06
|
—
|
|
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
Chloride, Day 14
|
-2.0 Millimoles per Liter
Standard Deviation 1.46
|
—
|
|
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
Phosphate, Day 7
|
0.017 Millimoles per Liter
Standard Deviation 0.0960
|
—
|
|
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
Phosphate, Day 14
|
0.026 Millimoles per Liter
Standard Deviation 0.1330
|
—
|
|
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
Potassium, Day 7
|
0.03 Millimoles per Liter
Standard Deviation 0.304
|
—
|
|
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
Potassium, Day 14
|
-0.03 Millimoles per Liter
Standard Deviation 0.328
|
—
|
|
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
Sodium, Day 7
|
-0.6 Millimoles per Liter
Standard Deviation 1.45
|
—
|
|
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
Sodium, Day 14
|
-0.6 Millimoles per Liter
Standard Deviation 1.59
|
—
|
|
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
Triglycerides, Day 7
|
0.092 Millimoles per Liter
Standard Deviation 0.4841
|
—
|
|
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
Triglycerides, Day 14
|
-0.044 Millimoles per Liter
Standard Deviation 0.4569
|
—
|
|
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
BUN, Day 7
|
-0.018 Millimoles per Liter
Standard Deviation 1.2157
|
—
|
|
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
BUN, Day 14
|
-0.195 Millimoles per Liter
Standard Deviation 1.0640
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Glucose, Day 3, n= 15
|
0.236 Millimoles per Liter
Standard Deviation 0.2463
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Glucose, Day 7, n= 15
|
0.315 Millimoles per Liter
Standard Deviation 0.3282
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Glucose, Day 9, n= 15
|
0.136 Millimoles per Liter
Standard Deviation 0.2433
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Cholesterol, Day 3, n=15
|
0.011 Millimoles per Liter
Standard Deviation 0.2372
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Cholesterol, Day 7, n= 15
|
0.102 Millimoles per Liter
Standard Deviation 0.3899
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Cholesterol, Day 9, n= 16
|
0.030 Millimoles per Liter
Standard Deviation 0.4594
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Anion gap, Day 3, n= 16
|
-0.4 Millimoles per Liter
Standard Deviation 1.82
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Anion gap, Day 7, n= 15
|
-0.5 Millimoles per Liter
Standard Deviation 1.73
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Anion gap, Day 9, n= 15
|
-0.3 Millimoles per Liter
Standard Deviation 1.67
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Calcium, Day 3, n= 16
|
0.013 Millimoles per Liter
Standard Deviation 0.0478
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Calcium, Day 7, n= 15
|
0.037 Millimoles per Liter
Standard Deviation 0.0568
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Calcium, Day 9, n= 15
|
0.033 Millimoles per Liter
Standard Deviation 0.0628
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
CO2, Day 3, n= 16
|
-0.5 Millimoles per Liter
Standard Deviation 1.26
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
CO2, Day 7, n= 15
|
-0.1 Millimoles per Liter
Standard Deviation 1.36
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
CO2, Day 9, n= 15
|
-0.4 Millimoles per Liter
Standard Deviation 1.18
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Chloride, Day 3, n= 16
|
2.3 Millimoles per Liter
Standard Deviation 1.20
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Chloride, Day 7, n= 15
|
0.6 Millimoles per Liter
Standard Deviation 1.35
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Chloride, Day 9, n= 15
|
1.3 Millimoles per Liter
Standard Deviation 1.72
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Phosphate, Day 3, n= 16
|
0.062 Millimoles per Liter
Standard Deviation 0.0683
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Phosphate, Day 7, n= 15
|
0.002 Millimoles per Liter
Standard Deviation 0.0800
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Phosphate, Day 9, n= 15
|
0.007 Millimoles per Liter
Standard Deviation 0.0584
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Potassium, Day 3, n= 16
|
0.01 Millimoles per Liter
Standard Deviation 0.284
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Potassium, Day 7, n= 15
|
-0.03 Millimoles per Liter
Standard Deviation 0.213
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Potassium, Day 9, n= 15
|
0.10 Millimoles per Liter
Standard Deviation 0.344
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Sodium, Day 3, n= 16
|
1.4 Millimoles per Liter
Standard Deviation 1.36
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Sodium, Day 7, n= 15
|
0.1 Millimoles per Liter
Standard Deviation 1.53
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Sodium, Day 9, n= 15
|
0.6 Millimoles per Liter
Standard Deviation 1.06
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Triglycerides, Day 3, n= 16
|
-0.003 Millimoles per Liter
Standard Deviation 0.1753
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Triglycerides, Day 7, n= 15
|
0.111 Millimoles per Liter
Standard Deviation 0.2414
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Triglycerides, Day 9, n= 15
|
-0.049 Millimoles per Liter
Standard Deviation 0.2747
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
BUN, Day 3, n= 16
|
0.312 Millimoles per Liter
Standard Deviation 0.5567
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
BUN, Day 7, n= 15
|
-0.031 Millimoles per Liter
Standard Deviation 0.5038
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
BUN, Day 9, n= 15
|
-0.028 Millimoles per Liter
Standard Deviation 0.4521
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Cholesterol, Day 7
|
4.249 Millimoles per Liter
Standard Deviation 0.8494
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Cholesterol, Day 14
|
3.864 Millimoles per Liter
Standard Deviation 0.6087
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Glucose, Baseline
|
5.111 Millimoles per Liter
Standard Deviation 0.3747
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Glucose, Day 7
|
4.951 Millimoles per Liter
Standard Deviation 0.2587
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Glucose, Day 14
|
4.791 Millimoles per Liter
Standard Deviation 0.2662
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Cholesterol, Baseline
|
4.253 Millimoles per Liter
Standard Deviation 0.7938
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Anion gap, Baseline
|
8.7 Millimoles per Liter
Standard Deviation 1.08
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Anion gap, Day 7
|
10.6 Millimoles per Liter
Standard Deviation 2.25
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Anion gap, Day 14
|
10.9 Millimoles per Liter
Standard Deviation 1.45
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Calcium, Baseline
|
2.359 Millimoles per Liter
Standard Deviation 0.0697
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Calcium, Day 7
|
2.387 Millimoles per Liter
Standard Deviation 0.0663
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Calcium, Day 14
|
2.387 Millimoles per Liter
Standard Deviation 0.0637
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
CO2, Baseline
|
31.7 Millimoles per Liter
Standard Deviation 1.49
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
CO2, Day 7
|
30.1 Millimoles per Liter
Standard Deviation 1.86
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
CO2, Day 14
|
30.8 Millimoles per Liter
Standard Deviation 1.38
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Chloride, Baseline
|
103.3 Millimoles per Liter
Standard Deviation 1.84
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Chloride, Day 7
|
102.2 Millimoles per Liter
Standard Deviation 1.72
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Chloride, Day 14
|
101.3 Millimoles per Liter
Standard Deviation 2.32
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Phosphate, Baseline
|
1.078 Millimoles per Liter
Standard Deviation 0.1301
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Phosphate, Day 7
|
1.094 Millimoles per Liter
Standard Deviation 0.1202
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Phosphate, Day 14
|
1.103 Millimoles per Liter
Standard Deviation 0.0807
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Potassium, Baseline
|
4.25 Millimoles per Liter
Standard Deviation 0.225
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Potassium, Day 7
|
4.28 Millimoles per Liter
Standard Deviation 0.161
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Potassium, Day 14
|
4.22 Millimoles per Liter
Standard Deviation 0.279
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Sodium, Baseline
|
139.4 Millimoles per Liter
Standard Deviation 1.45
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Sodium, Day 7
|
138.8 Millimoles per Liter
Standard Deviation 1.77
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Sodium, Day 14
|
138.8 Millimoles per Liter
Standard Deviation 1.69
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Triglycerides, Baseline
|
1.076 Millimoles per Liter
Standard Deviation 0.5825
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Triglycerides, Day 7
|
1.168 Millimoles per Liter
Standard Deviation 0.3759
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Triglycerides, Day 14
|
1.033 Millimoles per Liter
Standard Deviation 0.3034
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
BUN, Baseline
|
4.441 Millimoles per Liter
Standard Deviation 1.2792
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
BUN, Day 7
|
4.423 Millimoles per Liter
Standard Deviation 0.9623
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
BUN, Day 14
|
4.246 Millimoles per Liter
Standard Deviation 0.7820
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Glucose, Baseline, n= 16
|
4.791 Millimoles per Liter
Standard Deviation 0.2662
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Glucose, Day 3, n= 15
|
5.027 Millimoles per Liter
Standard Deviation 0.2894
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Glucose, Day 7, n= 15
|
5.129 Millimoles per Liter
Standard Deviation 0.3388
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Glucose, Day 9, n= 15
|
4.950 Millimoles per Liter
Standard Deviation 0.3360
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Cholesterol, Baseline, n= 16
|
3.864 Millimoles per Liter
Standard Deviation 0.6087
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Cholesterol, Day 3, n=15
|
3.875 Millimoles per Liter
Standard Deviation 0.6509
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Cholesterol, Day 7, n= 15
|
3.894 Millimoles per Liter
Standard Deviation 0.7575
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Cholesterol, Day 9, n= 16
|
3.822 Millimoles per Liter
Standard Deviation 0.7838
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Anion gap, Baseline, n= 16
|
10.9 Millimoles per Liter
Standard Deviation 1.45
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Anion gap, Day 3, n= 16
|
10.5 Millimoles per Liter
Standard Deviation 1.37
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Anion gap, Day 7, n= 15
|
10.3 Millimoles per Liter
Standard Deviation 1.28
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Anion gap, Day 9, n= 15
|
10.5 Millimoles per Liter
Standard Deviation 0.74
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Calcium, Baseline, n= 16
|
2.387 Millimoles per Liter
Standard Deviation 0.0637
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Calcium, Day 3, n= 16
|
2.399 Millimoles per Liter
Standard Deviation 0.0682
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Calcium, Day 7, n= 15
|
2.424 Millimoles per Liter
Standard Deviation 0.0693
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Calcium, Day 9, n= 15
|
2.421 Millimoles per Liter
Standard Deviation 0.0670
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
CO2, Baseline, n= 16
|
30.8 Millimoles per Liter
Standard Deviation 1.38
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
CO2, Day 3, n= 16
|
30.3 Millimoles per Liter
Standard Deviation 1.96
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
CO2, Day 7, n= 15
|
30.7 Millimoles per Liter
Standard Deviation 1.91
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
CO2, Day 9, n= 15
|
30.5 Millimoles per Liter
Standard Deviation 1.30
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Chloride, Baseline, n= 16
|
101.3 Millimoles per Liter
Standard Deviation 2.32
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Chloride, Day 3, n= 16
|
103.6 Millimoles per Liter
Standard Deviation 1.50
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Chloride, Day 7, n= 15
|
101.9 Millimoles per Liter
Standard Deviation 1.62
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Chloride, Day 9, n= 15
|
102.7 Millimoles per Liter
Standard Deviation 1.50
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Phosphate, Baseline, n= 16
|
1.103 Millimoles per Liter
Standard Deviation 0.0807
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Phosphate, Day 3, n= 16
|
1.165 Millimoles per Liter
Standard Deviation 0.1007
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Phosphate, Day 7, n= 15
|
1.112 Millimoles per Liter
Standard Deviation 0.1097
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Phosphate, Day 9, n= 15
|
1.117 Millimoles per Liter
Standard Deviation 0.0952
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Potassium, Baseline, n= 16
|
4.22 Millimoles per Liter
Standard Deviation 0.279
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Potassium, Day 3, n= 16
|
4.23 Millimoles per Liter
Standard Deviation 0.241
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Potassium, Day 7, n= 15
|
4.21 Millimoles per Liter
Standard Deviation 0.236
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Potassium, Day 9, n= 15
|
4.35 Millimoles per Liter
Standard Deviation 0.226
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Sodium, Baseline, n= 16
|
138.8 Millimoles per Liter
Standard Deviation 1.69
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Sodium, Day 3, n= 16
|
140.2 Millimoles per Liter
Standard Deviation 1.56
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Sodium, Day 7, n= 15
|
138.8 Millimoles per Liter
Standard Deviation 1.42
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Sodium, Day 9, n=15
|
139.3 Millimoles per Liter
Standard Deviation 1.18
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Triglycerides, Baseline, n= 16
|
1.033 Millimoles per Liter
Standard Deviation 0.3034
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Triglycerides, Day 3, n= 16
|
1.029 Millimoles per Liter
Standard Deviation 0.3440
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Triglycerides, Day 7, n= 15
|
1.120 Millimoles per Liter
Standard Deviation 0.4358
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Triglycerides, Day 9, n= 15
|
0.961 Millimoles per Liter
Standard Deviation 0.4320
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
BUN, Baseline, n= 16
|
4.246 Millimoles per Liter
Standard Deviation 0.7820
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
BUN, Day 3, n= 16
|
4.558 Millimoles per Liter
Standard Deviation 0.8267
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
BUN, Day 7, n= 15
|
4.260 Millimoles per Liter
Standard Deviation 0.8705
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
BUN Day 9, n= 15
|
4.263 Millimoles per Liter
Standard Deviation 0.6977
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
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)
Alkaline phosphatase, Day 7
|
-2.6 International units per Liter
Standard Deviation 5.10
|
—
|
|
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)
Alkaline phosphatase, Day 14
|
2.4 International units per Liter
Standard Deviation 6.91
|
—
|
|
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)
AST, Day 7
|
-6.2 International units per Liter
Standard Deviation 4.59
|
—
|
|
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)
AST, Day 14
|
-6.9 International units per Liter
Standard Deviation 4.95
|
—
|
|
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)
ALT, Day 7
|
-2.1 International units per Liter
Standard Deviation 7.26
|
—
|
|
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)
ALT, Day 14
|
-6.2 International units per Liter
Standard Deviation 6.98
|
—
|
|
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)
GGT Day 7
|
0.2 International units per Liter
Standard Deviation 2.32
|
—
|
|
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)
GGT Day 14
|
-1.7 International units per Liter
Standard Deviation 3.63
|
—
|
|
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)
LDH, Day 7
|
-14.6 International units per Liter
Standard Deviation 13.07
|
—
|
|
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)
LDH, Day 14
|
-12.0 International units per Liter
Standard Deviation 16.25
|
—
|
|
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)
CK, Day 7
|
-103.0 International units per Liter
Standard Deviation 127.10
|
—
|
|
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)
CK, Day 14
|
-99.2 International units per Liter
Standard Deviation 135.80
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
Alkaline phosphatase, Day 3, n= 16
|
3.7 International units per Liter
Standard Deviation 3.48
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
Alkaline phosphatase, Day 7, n= 15
|
2.6 International units per Liter
Standard Deviation 3.64
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
Alkaline phosphatase, Day 9, n= 15
|
-1.0 International units per Liter
Standard Deviation 3.98
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
AST, Day 3, n= 16
|
-1.4 International units per Liter
Standard Deviation 1.31
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
AST, Day 7, n= 15
|
-0.5 International units per Liter
Standard Deviation 2.45
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
AST, Day 9, n= 15
|
-0.1 International units per Liter
Standard Deviation 2.13
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
ALT, Day 3, n= 16
|
-2.0 International units per Liter
Standard Deviation 1.63
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
ALT, Day 7, n= 15
|
-1.9 International units per Liter
Standard Deviation 2.76
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
ALT, Day 9, n= 15
|
-0.7 International units per Liter
Standard Deviation 4.56
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
GGT, Day 3, n= 16
|
-0.9 International units per Liter
Standard Deviation 1.18
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
GGT, Day 7, n= 15
|
-1.4 International units per Liter
Standard Deviation 1.50
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
GGT, Day 9, n= 15
|
-1.9 International units per Liter
Standard Deviation 2.55
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
LDH, Day 3, n= 16
|
-7.0 International units per Liter
Standard Deviation 11.98
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
LDH, Day 7, n= 15
|
-8.2 International units per Liter
Standard Deviation 12.73
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
LDH, Day 9, n= 15
|
-7.0 International units per Liter
Standard Deviation 11.98
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
CK, Day 3, n= 16
|
3.4 International units per Liter
Standard Deviation 29.12
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
CK, Day 7, n= 15
|
11.3 International units per Liter
Standard Deviation 33.83
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
CK, Day 9, n= 15
|
-2.3 International units per Liter
Standard Deviation 22.65
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
Alkaline phosphatase, Baseline
|
60.9 International units per Liter
Standard Deviation 9.33
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
Alkaline phosphatase, Day 7
|
58.3 International units per Liter
Standard Deviation 8.36
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
Alkaline phosphatase, Day 14
|
63.4 International units per Liter
Standard Deviation 8.82
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
AST, Baseline
|
24.6 International units per Liter
Standard Deviation 6.16
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
AST, Day 7
|
18.4 International units per Liter
Standard Deviation 4.79
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
AST, Day 14
|
17.6 International units per Liter
Standard Deviation 3.46
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
ALT, Baseline
|
26.6 International units per Liter
Standard Deviation 10.44
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
ALT, Day 7
|
24.4 International units per Liter
Standard Deviation 13.28
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
ALT, Day 14
|
20.4 International units per Liter
Standard Deviation 8.59
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
GGT Baseline
|
1.76 International units per Liter
Standard Deviation 1.016
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
GGT Day 7
|
1.91 International units per Liter
Standard Deviation 0.752
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
GGT Day 14
|
2.40 International units per Liter
Standard Deviation 1.035
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
LDH, Baseline
|
138.0 International units per Liter
Standard Deviation 19.77
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
LDH, Day 7
|
123.4 International units per Liter
Standard Deviation 19.67
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
LDH, Day 9
|
126.0 International units per Liter
Standard Deviation 19.50
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
CK, Baseline
|
219.6 International units per Liter
Standard Deviation 150.90
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
CK, Day 7
|
116.6 International units per Liter
Standard Deviation 49.16
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
CK, Day 14
|
120.4 International units per Liter
Standard Deviation 62.41
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
Alkaline phosphatase, Baseline Day 3, n= 16
|
63.4 International units per Liter
Standard Deviation 8.82
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
Alkaline phosphatase, Day 3, n= 16
|
67.1 International units per Liter
Standard Deviation 10.45
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
Alkaline phosphatase, Day 7, n= 15
|
65.4 International units per Liter
Standard Deviation 9.81
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
Alkaline phosphatase, Day 9, n= 15
|
61.8 International units per Liter
Standard Deviation 9.65
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
AST, Baseline, n= 16
|
17.6 International units per Liter
Standard Deviation 3.46
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
AST, Day 3, n= 16
|
16.2 International units per Liter
Standard Deviation 3.04
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
AST, Day 7, n= 15
|
17.2 International units per Liter
Standard Deviation 3.38
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
AST, Day 9, n= 15
|
17.6 International units per Liter
Standard Deviation 3.83
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
ALT, Baseline, n= 16
|
20.4 International units per Liter
Standard Deviation 8.59
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
ALT, Day 3, n= 16
|
18.4 International units per Liter
Standard Deviation 7.87
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
ALT, Day 7, n= 15
|
18.5 International units per Liter
Standard Deviation 8.31
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
ALT, Day 9, n= 15
|
19.7 International units per Liter
Standard Deviation 9.43
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
GGT, Baseline, n= 16
|
2.40 International units per Liter
Standard Deviation 1.035
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
GGT, Day 3, n= 16
|
2.14 International units per Liter
Standard Deviation 1.065
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
GGT, Day 7, n= 15
|
2.41 International units per Liter
Standard Deviation 0.828
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
GGT, Day 9, n= 15
|
1.95 International units per Liter
Standard Deviation 0.673
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
LDH, Baseline, n= 16
|
126.0 International units per Liter
Standard Deviation 19.50
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
LDH, Day 3, n= 16
|
119.0 International units per Liter
Standard Deviation 19.37
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
LDH, Day 7, n= 15
|
118.0 International units per Liter
Standard Deviation 13.93
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
LDH, Day 9, n= 15
|
119.2 International units per Liter
Standard Deviation 17.70
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
CK, Baseline, n= 16
|
120.4 International units per Liter
Standard Deviation 62.41
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
CK, Day 3, n= 16
|
123.8 International units per Liter
Standard Deviation 51.53
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
CK, Day 7, n= 15
|
135.8 International units per Liter
Standard Deviation 66.33
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
CK, Day 9, n= 15
|
122.2 International units per Liter
Standard Deviation 54.94
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase
Amylase, Day 7
|
-2.3 Units per Liter
Standard Deviation 9.68
|
—
|
|
Period 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase
Amylase, Day 14
|
-2.8 Units per Liter
Standard Deviation 10.48
|
—
|
|
Period 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase
Lipase, Day 7
|
-4.0 Units per Liter
Standard Deviation 8.93
|
—
|
|
Period 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase
Lipase, Day 14
|
-5.3 Units per Liter
Standard Deviation 12.69
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase
Amylase, Day 3, n= 16
|
3.3 Units per Liter
Standard Deviation 8.93
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase
Amylase, Day 7, n= 15
|
-1.9 Units per Liter
Standard Deviation 6.77
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase
Amylase, Day 9, n= 15
|
1.1 Units per Liter
Standard Deviation 6.32
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase
Lipase, Day 3, n= 16
|
7.7 Units per Liter
Standard Deviation 21.62
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase
Lipase, Day 7, n= 15
|
0.0 Units per Liter
Standard Deviation 8.20
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase
Lipase, Day 9, n= 15
|
3.5 Units per Liter
Standard Deviation 3.89
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase
Amylase, Baseline
|
56.4 Units per Liter
Standard Deviation 14.66
|
—
|
|
Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase
Amylase, Day 7
|
54.1 Units per Liter
Standard Deviation 13.15
|
—
|
|
Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase
Amylase, Day 14
|
53.6 Units per Liter
Standard Deviation 14.48
|
—
|
|
Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase
Lipase, Baseline
|
22.2 Units per Liter
Standard Deviation 14.00
|
—
|
|
Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase
Lipase, Day 7
|
18.2 Units per Liter
Standard Deviation 9.72
|
—
|
|
Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase
Lipase, Day 14
|
16.9 Units per Liter
Standard Deviation 14.65
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase
Amylase, Baseline, n= 16
|
53.6 Units per Liter
Standard Deviation 14.48
|
—
|
|
Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase
Amylase, Day 3, n= 16
|
56.8 Units per Liter
Standard Deviation 19.32
|
—
|
|
Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase
Amylase, Day 7, n= 15
|
52.7 Units per Liter
Standard Deviation 12.97
|
—
|
|
Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase
Amylase, Day 9, n= 15
|
55.7 Units per Liter
Standard Deviation 13.39
|
—
|
|
Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase
Lipase, Baseline, n= 16
|
16.9 Units per Liter
Standard Deviation 14.65
|
—
|
|
Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase
Lipase, Day 3, n= 16
|
24.6 Units per Liter
Standard Deviation 34.82
|
—
|
|
Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase
Lipase, Day 7, n= 15
|
17.5 Units per Liter
Standard Deviation 10.69
|
—
|
|
Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase
Lipase, Day 9, n= 15
|
21.0 Units per Liter
Standard Deviation 14.16
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Creatinine, Day 7
|
5.69 Micromoles per liter
Standard Deviation 3.508
|
—
|
|
Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Creatinine, Day 14
|
7.36 Micromoles per liter
Standard Deviation 4.833
|
—
|
|
Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Total bilirubin, Day 7
|
2.25 Micromoles per liter
Standard Deviation 4.756
|
—
|
|
Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Total bilirubin, Day 14
|
2.10 Micromoles per liter
Standard Deviation 5.109
|
—
|
|
Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Direct bilirubin, Day 7
|
0.15 Micromoles per liter
Standard Deviation 0.634
|
—
|
|
Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Direct bilirubin, Day 14
|
0.64 Micromoles per liter
Standard Deviation 0.699
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Creatinine, Day 3, n= 16
|
-2.34 Micromoles per liter
Standard Deviation 3.755
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Creatinine, Day 7, n= 15
|
3.53 Micromoles per liter
Standard Deviation 3.802
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Creatinine, Day 9, n= 15
|
0.28 Micromoles per liter
Standard Deviation 3.569
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Total bilirubin, Day 3, n= 16
|
-0.82 Micromoles per liter
Standard Deviation 3.475
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Total bilirubin, Day 7, n= 15
|
-0.26 Micromoles per liter
Standard Deviation 2.466
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Total bilirubin, Day 9, n= 15
|
-1.91 Micromoles per liter
Standard Deviation 2.252
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Direct bilirubin, Day 3, n= 16
|
-0.26 Micromoles per liter
Standard Deviation 0.534
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Direct bilirubin, Day 7, n= 15
|
-0.03 Micromoles per liter
Standard Deviation 0.547
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Direct bilirubin, Day 9, n= 15
|
-0.49 Micromoles per liter
Standard Deviation 0.501
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Creatinine, Baseline
|
80.16 Micromoles per liter
Standard Deviation 10.103
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Creatinine, Day 7
|
85.85 Micromoles per liter
Standard Deviation 9.586
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Creatinine, Day 14
|
87.52 Micromoles per liter
Standard Deviation 10.058
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Total bilirubin, Baseline
|
9.64 Micromoles per liter
Standard Deviation 6.143
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Total bilirubin, Day 7
|
11.89 Micromoles per liter
Standard Deviation 6.781
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Total bilirubin, Day 14
|
11.74 Micromoles per liter
Standard Deviation 7.046
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Direct bilirubin, Baseline
|
1.76 Micromoles per liter
Standard Deviation 1.016
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Direct bilirubin, Day 7
|
1.91 Micromoles per liter
Standard Deviation 0.752
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Direct bilirubin, Day 14
|
2.40 Micromoles per liter
Standard Deviation 1.035
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Creatinine, Baseline, n= 16
|
87.52 Micromoles per liter
Standard Deviation 10.058
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Creatinine, Day 3, n= 16
|
85.18 Micromoles per liter
Standard Deviation 10.314
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Creatinine, Day 7, n= 15
|
91.53 Micromoles per liter
Standard Deviation 9.504
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Creatinine, Day 9, n= 15
|
88.27 Micromoles per liter
Standard Deviation 9.916
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Total bilirubin, Baseline, n= 16
|
11.44 Micromoles per liter
Standard Deviation 6.022
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Total bilirubin, Day 3, n= 16
|
10.62 Micromoles per liter
Standard Deviation 7.886
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Total bilirubin, Day 7, n= 15
|
11.33 Micromoles per liter
Standard Deviation 5.487
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Total bilirubin, Day 9, n= 15
|
9.68 Micromoles per liter
Standard Deviation 4.603
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Direct bilirubin, Baseline, n= 16
|
2.40 Micromoles per liter
Standard Deviation 1.035
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Direct bilirubin, Day 3, n= 16
|
2.14 Micromoles per liter
Standard Deviation 1.065
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Direct bilirubin, Day 7, n= 15
|
2.41 Micromoles per liter
Standard Deviation 0.828
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Direct bilirubin, Day 9, n= 15
|
1.95 Micromoles per liter
Standard Deviation 0.673
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Total Protein, Day 7
|
2.6 Grams per Liter
Standard Deviation 3.20
|
—
|
|
Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Total Protein, Day 14
|
2.9 Grams per Liter
Standard Deviation 2.66
|
—
|
|
Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Globulin, Day 7
|
2.5 Grams per Liter
Standard Deviation 1.37
|
—
|
|
Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Globulin, Day 14
|
2.8 Grams per Liter
Standard Deviation 1.91
|
—
|
|
Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Albumin, Day 7
|
0.1 Grams per Liter
Standard Deviation 2.22
|
—
|
|
Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Albumin, Day 14
|
0.1 Grams per Liter
Standard Deviation 2.05
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Total Protein, Day 3, n= 16
|
0.1 Grams per Liter
Standard Deviation 2.68
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Total Protein, Day 7, n= 15
|
3.1 Grams per Liter
Standard Deviation 2.85
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Total Protein, Day 9, n= 15
|
0.8 Grams per Liter
Standard Deviation 3.28
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Globulin, Day 3, n= 16
|
0.2 Grams per Liter
Standard Deviation 1.17
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Globulin, Day 7, n= 15
|
2.3 Grams per Liter
Standard Deviation 0.96
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Globulin, Day 9, n= 15
|
0.2 Grams per Liter
Standard Deviation 1.08
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Albumin, Day 3, n= 16
|
-0.1 Grams per Liter
Standard Deviation 1.95
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Albumin, Day 7, n= 15
|
0.9 Grams per Liter
Standard Deviation 2.20
|
—
|
|
Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Albumin, Day 9, n= 15
|
0.6 Grams per Liter
Standard Deviation 2.50
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Total Protein, Baseline
|
69.8 Grams per Liter
Standard Deviation 3.64
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Total Protein, Day 7
|
72.4 Grams per Liter
Standard Deviation 3.70
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Total Protein, Day 14
|
72.6 Grams per Liter
Standard Deviation 3.10
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Globulin, Baseline
|
25.9 Grams per Liter
Standard Deviation 2.50
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Globulin, Day 7
|
28.4 Grams per Liter
Standard Deviation 2.60
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Globulin, Day 14
|
28.7 Grams per Liter
Standard Deviation 1.99
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Albumin, Baseline
|
43.9 Grams per Liter
Standard Deviation 2.36
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Albumin, Day 7
|
44.0 Grams per Liter
Standard Deviation 1.90
|
—
|
|
Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Albumin, Day 14
|
43.9 Grams per Liter
Standard Deviation 2.41
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Total Protein, Baseline, n= 16
|
72.6 Grams per Liter
Standard Deviation 3.10
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Total Protein, Day 3, n= 16
|
72.8 Grams per Liter
Standard Deviation 2.96
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Total Protein, Day 7, n= 15
|
75.7 Grams per Liter
Standard Deviation 2.89
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Total Protein, Day 9, n= 15
|
73.3 Grams per Liter
Standard Deviation 2.61
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Globulin, Baseline, n= 16
|
28.7 Grams per Liter
Standard Deviation 1.99
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Globulin, Day 3, n= 16
|
28.9 Grams per Liter
Standard Deviation 2.31
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Globulin, Day 7, n= 15
|
30.9 Grams per Liter
Standard Deviation 1.96
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Globulin, Day 9, n= 15
|
28.8 Grams per Liter
Standard Deviation 1.90
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Albumin, Baseline, n= 16
|
43.9 Grams per Liter
Standard Deviation 2.41
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Albumin, Day 3, n= 16
|
43.9 Grams per Liter
Standard Deviation 1.89
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Albumin, Day 7, n= 15
|
44.8 Grams per Liter
Standard Deviation 2.08
|
—
|
|
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Albumin, Day 9, n= 15
|
44.5 Grams per Liter
Standard Deviation 1.73
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Change From Baseline in Specific Gravity of Urine
Day 7
|
0.0007 Ratio
Standard Deviation 0.01085
|
—
|
|
Period 1: Change From Baseline in Specific Gravity of Urine
Day 14
|
0.0011 Ratio
Standard Deviation 0.00941
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Change From Baseline in Specific Gravity of Urine
Day 3, n= 16
|
0.0031 Ratio
Standard Deviation 0.00666
|
—
|
|
Period 2: Change From Baseline in Specific Gravity of Urine
Day 7, n= 15
|
0.0024 Ratio
Standard Deviation 0.00608
|
—
|
|
Period 2: Change From Baseline in Specific Gravity of Urine
Day 9, n= 15
|
0.0005 Ratio
Standard Deviation 0.00872
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Absolute Values of Specific Gravity of Urine
Baseline
|
1.0136 Ratio
Standard Deviation 0.01095
|
—
|
|
Period 1: Absolute Values of Specific Gravity of Urine
Day 7
|
1.0143 Ratio
Standard Deviation 0.00556
|
—
|
|
Period 1: Absolute Values of Specific Gravity of Urine
Day 14
|
1.0147 Ratio
Standard Deviation 0.00789
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Absolute Values of Specific Gravity of Urine
Baseline, n= 16
|
1.0147 Ratio
Standard Deviation 0.00789
|
—
|
|
Period 2: Absolute Values of Specific Gravity of Urine
Day 3, n= 16
|
1.0178 Ratio
Standard Deviation 0.00584
|
—
|
|
Period 2: Absolute Values of Specific Gravity of Urine
Day 7, n= 15
|
1.0170 Ratio
Standard Deviation 0.00655
|
—
|
|
Period 2: Absolute Values of Specific Gravity of Urine
Day 9, n= 15
|
1.0151 Ratio
Standard Deviation 0.00788
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Change From Baseline in Potential of Hydrogen (pH) of Urine
Day 7
|
-0.34 pH
Standard Deviation 0.397
|
—
|
|
Period 1: Change From Baseline in Potential of Hydrogen (pH) of Urine
Day 14
|
-0.19 pH
Standard Deviation 0.544
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Change From Baseline in pH of Urine
Day 3, n= 16
|
0.19 pH
Standard Deviation 0.479
|
—
|
|
Period 2: Change From Baseline in pH of Urine
Day 7, n= 15
|
0.10 pH
Standard Deviation 0.471
|
—
|
|
Period 2: Change From Baseline in pH of Urine
Day 9, n= 15
|
0.10 pH
Standard Deviation 0.507
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Absolute Values of pH of Urine
Baseline
|
6.22 pH
Standard Deviation 0.446
|
—
|
|
Period 1: Absolute Values of pH of Urine
Day 7
|
5.88 pH
Standard Deviation 0.289
|
—
|
|
Period 1: Absolute Values of pH of Urine
Day 14
|
6.03 pH
Standard Deviation 0.531
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Absolute Values of pH of Urine
Baseline, n= 16
|
6.03 pH
Standard Deviation 0.531
|
—
|
|
Period 2: Absolute Values of pH of Urine
Day 3, n= 16
|
6.22 pH
Standard Deviation 0.482
|
—
|
|
Period 2: Absolute Values of pH of Urine
Day 7, n= 15
|
6.07 pH
Standard Deviation 0.320
|
—
|
|
Period 2: Absolute Values of pH of Urine
Day 9, n= 15
|
6.07 pH
Standard Deviation 0.320
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Change From Baseline in Urine Urobilinogen
Day 7
|
-2.5395 Micromoles per liter
Standard Deviation 5.45976
|
—
|
|
Period 1: Change From Baseline in Urine Urobilinogen
Day 14
|
-2.5395 Micromoles per liter
Standard Deviation 5.45976
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Change From Baseline in Urine Urobilinogen
Day 3, n= 16
|
0.0000 Micromoles per liter
Standard Deviation 0.00000
|
—
|
|
Period 2: Change From Baseline in Urine Urobilinogen
Day 7, n= 15
|
0.0000 Micromoles per liter
Standard Deviation 0.00000
|
—
|
|
Period 2: Change From Baseline in Urine Urobilinogen
Day 9, n= 15
|
0.0000 Micromoles per liter
Standard Deviation 0.00000
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 7, 14Population: Safety Population
Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Absolute Values of Urine Urobilinogen
Baseline
|
5.9255 Micromoles per liter
Standard Deviation 5.45976
|
—
|
|
Period 1: Absolute Values of Urine Urobilinogen
Day 7
|
3.3860 Micromoles per liter
Standard Deviation 0.0000
|
—
|
|
Period 1: Absolute Values of Urine Urobilinogen
Day 14
|
3.3860 Micromoles per liter
Standard Deviation 0.0000
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 3, 7, 9Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Absolute Values of Urine Urobilinogen
Day 9, n= 15
|
3.3860 Micromoles per liter
Standard Deviation 0.0000
|
—
|
|
Period 2: Absolute Values of Urine Urobilinogen
Baseline, n= 16
|
3.3860 Micromoles per liter
Standard Deviation 0.0000
|
—
|
|
Period 2: Absolute Values of Urine Urobilinogen
Day 3, n= 16
|
3.3860 Micromoles per liter
Standard Deviation 0.0000
|
—
|
|
Period 2: Absolute Values of Urine Urobilinogen
Day 7, n= 15
|
3.3860 Micromoles per liter
Standard Deviation 0.0000
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dosePopulation: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Change From Baseline in Heart Rate
Day 1, 2 hours post-dose
|
1.5 Beats per minute
Standard Deviation 6.87
|
—
|
|
Period 1: Change From Baseline in Heart Rate
Day 1, 4 hours post-dose
|
-3.3 Beats per minute
Standard Deviation 10.37
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Change From Baseline in Heart Rate
Day 1, 2 hours post-dose, n= 16
|
5.0 Beats per minute
Standard Deviation 4.37
|
—
|
|
Period 2: Change From Baseline in Heart Rate
Day 1, 4 hours post-dose, n= 16
|
2.8 Beats per minute
Standard Deviation 6.62
|
—
|
|
Period 2: Change From Baseline in Heart Rate
Day 4, Pre-dose, n= 15
|
-0.5 Beats per minute
Standard Deviation 11.10
|
—
|
|
Period 2: Change From Baseline in Heart Rate
Day 4, 2 hours post-dose, n= 15
|
3.3 Beats per minute
Standard Deviation 5.86
|
—
|
|
Period 2: Change From Baseline in Heart Rate
Day 4, 4 hours post-dose, n= 15
|
-0.3 Beats per minute
Standard Deviation 5.13
|
—
|
|
Period 2: Change From Baseline in Heart Rate
Day 7, Pre-dose, n= 15
|
0.3 Beats per minute
Standard Deviation 11.18
|
—
|
|
Period 2: Change From Baseline in Heart Rate
Day 7, 2 hours post-dose, n= 15
|
1.8 Beats per minute
Standard Deviation 6.72
|
—
|
|
Period 2: Change From Baseline in Heart Rate
Day 7, 4 hours post-dose, n= 15
|
-2.3 Beats per minute
Standard Deviation 7.08
|
—
|
|
Period 2: Change From Baseline in Heart Rate
Day 9 post-dose, n= 15
|
2.1 Beats per minute
Standard Deviation 7.84
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dosePopulation: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Absolute Values of Heart Rate
Baseline
|
67.6 Beats per minute
Standard Deviation 8.72
|
—
|
|
Period 1: Absolute Values of Heart Rate
Day 1, 2 hours post-dose
|
69.1 Beats per minute
Standard Deviation 11.04
|
—
|
|
Period 1: Absolute Values of Heart Rate
Day 1, 4 hours post-dose
|
64.4 Beats per minute
Standard Deviation 11.87
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Absolute Values of Heart Rate
Day 4, 4 hours post-dose, n= 15
|
65.3 Beats per minute
Standard Deviation 8.97
|
—
|
|
Period 2: Absolute Values of Heart Rate
Baseline, n= 16
|
66.5 Beats per minute
Standard Deviation 8.06
|
—
|
|
Period 2: Absolute Values of Heart Rate
Day 1, 2 hours post-dose, n= 16
|
71.5 Beats per minute
Standard Deviation 9.95
|
—
|
|
Period 2: Absolute Values of Heart Rate
Day 1, 4 hours post-dose, n= 16
|
69.3 Beats per minute
Standard Deviation 11.38
|
—
|
|
Period 2: Absolute Values of Heart Rate
Day 4, Pre-dose, n= 15
|
65.1 Beats per minute
Standard Deviation 10.48
|
—
|
|
Period 2: Absolute Values of Heart Rate
Day 4, 2 hours post-dose, n= 15
|
68.9 Beats per minute
Standard Deviation 8.00
|
—
|
|
Period 2: Absolute Values of Heart Rate
Day 7, Pre-dose, n= 15
|
65.9 Beats per minute
Standard Deviation 10.25
|
—
|
|
Period 2: Absolute Values of Heart Rate
Day 7, 2 hours post-dose, n= 15
|
67.4 Beats per minute
Standard Deviation 6.39
|
—
|
|
Period 2: Absolute Values of Heart Rate
Day 7, 4 hours post-dose, n= 15
|
63.3 Beats per minute
Standard Deviation 8.31
|
—
|
|
Period 2: Absolute Values of Heart Rate
Day 9 post-dose, n= 15
|
67.7 Beats per minute
Standard Deviation 9.23
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dosePopulation: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
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
PR Interval, Day 1, 2 hours post-dose
|
1.5 Milliseconds
Standard Deviation 9.67
|
—
|
|
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
PR Interval, Day 1, 4 hours post-dose
|
-1.9 Milliseconds
Standard Deviation 8.64
|
—
|
|
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
QRS Duration, Day 1, 2 hours post-dose
|
-1.1 Milliseconds
Standard Deviation 3.68
|
—
|
|
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
QRS Duration, Day 1, 4 hours post-dose
|
0.3 Milliseconds
Standard Deviation 4.96
|
—
|
|
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
QT Interval, Day 1, 2 hours post-dose
|
-7.5 Milliseconds
Standard Deviation 14.12
|
—
|
|
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
QT Interval, Day 1, 4 hours post-dose
|
5.8 Milliseconds
Standard Deviation 23.18
|
—
|
|
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
QTcF Interval, Day 1, 2 hours post-dose
|
-4.9 Milliseconds
Standard Deviation 10.63
|
—
|
|
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
QTcF Interval, Day 1, 4 hours post-dose
|
-1.3 Milliseconds
Standard Deviation 10.56
|
—
|
|
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
QTcB Interval, Day 1, 2 hours post-dose
|
-4.1 Milliseconds
Standard Deviation 12.70
|
—
|
|
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
QTcB Interval, Day 1, 4 hours post-dose
|
-5.4 Milliseconds
Standard Deviation 12.39
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
PR Interval, Day 1, 2 hours post-dose, n= 16
|
-6.8 Milliseconds
Standard Deviation 6.77
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
PR Interval, Day 1, 4 hours post-dose, n= 16
|
-3.7 Milliseconds
Standard Deviation 5.99
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
PR Interval, Day 4, Pre-dose, n= 15
|
-0.5 Milliseconds
Standard Deviation 4.56
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
PR Interval, Day 4, 2 hours post-dose, n= 15
|
-6.9 Milliseconds
Standard Deviation 6.67
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
PR Interval, Day 4, 4 hours post-dose, n= 15
|
-3.9 Milliseconds
Standard Deviation 7.83
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
PR Interval, Day 7, Pre-dose, n= 15
|
-2.7 Milliseconds
Standard Deviation 8.57
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
PR Interval, Day 7, 2 hours post-dose, n= 15
|
-3.3 Milliseconds
Standard Deviation 7.06
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
PR Interval, Day 7, 4 hours post-dose, n= 15
|
-3.7 Milliseconds
Standard Deviation 8.53
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
PR Interval, Day 9 post-dose, n= 15
|
1.2 Milliseconds
Standard Deviation 6.42
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QRS Duration, Day 1, 2 hours post-dose, n= 16
|
-2.5 Milliseconds
Standard Deviation 4.40
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QRS Duration, Day 1, 4 hours post-dose, n= 16
|
-1.4 Milliseconds
Standard Deviation 4.69
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QRS Duration, Day 4, Pre-dose, n= 15
|
0.5 Milliseconds
Standard Deviation 3.44
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QRS Duration, Day 4, 2 hours post-dose, n= 15
|
0.5 Milliseconds
Standard Deviation 5.72
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QRS Duration, Day 4, 4 hours post-dose, n= 15
|
-0.2 Milliseconds
Standard Deviation 2.70
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QRS Duration, Day 7, Pre-dose, n= 15
|
3.3 Milliseconds
Standard Deviation 4.53
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QRS Duration, Day 7, 2 hours post-dose, n= 15
|
1.5 Milliseconds
Standard Deviation 5.15
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QRS Duration, Day 7, 4 hours post-dose, n= 15
|
0.3 Milliseconds
Standard Deviation 3.72
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QRS Duration, Day 9 post-dose, n= 15
|
3.0 Milliseconds
Standard Deviation 5.36
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QT Interval, Day 1, 2 hours post-dose, n= 16
|
-12.6 Milliseconds
Standard Deviation 9.11
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QT Interval, Day 1, 4 hours post-dose, n= 16
|
-1.8 Milliseconds
Standard Deviation 14.72
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QT Interval, Day 4, Pre-dose, n= 15
|
7.3 Milliseconds
Standard Deviation 18.27
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QT Interval, Day 4, 2 hours post-dose, n= 15
|
-6.8 Milliseconds
Standard Deviation 15.72
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QT Interval, Day 4, 4 hours post-dose, n= 15
|
5.6 Milliseconds
Standard Deviation 14.64
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QT Interval, Day 7, Pre-dose, n= 15
|
3.5 Milliseconds
Standard Deviation 18.31
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QT Interval, Day 7, 2 hours post-dose, n= 15
|
-8.4 Milliseconds
Standard Deviation 16.15
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QT Interval, Day 7, 4 hours post-dose, n= 15
|
5.8 Milliseconds
Standard Deviation 17.37
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QT Interval, Day 9 post-dose, n= 15
|
4.1 Milliseconds
Standard Deviation 16.46
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcF Interval, Day 1, 2 hours post-dose, n= 16
|
-4.4 Milliseconds
Standard Deviation 7.29
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcF Interval, Day 1, 4 hours post-dose, n= 16
|
2.4 Milliseconds
Standard Deviation 7.77
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcF Interval, Day 4, Pre-dose, n= 15
|
6.1 Milliseconds
Standard Deviation 11.17
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcF Interval, Day 4, 2 hours post-dose, n= 15
|
-0.6 Milliseconds
Standard Deviation 10.91
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcF Interval, Day 4, 4 hours post-dose, n= 15
|
4.5 Milliseconds
Standard Deviation 8.22
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcF Interval, Day 7, Pre-dose, n= 15
|
4.1 Milliseconds
Standard Deviation 8.71
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcF Interval, Day 7, 2 hours post-dose, n= 15
|
-5.1 Milliseconds
Standard Deviation 9.34
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcF Interval, Day 7, 4 hours post-dose, n= 15
|
0.6 Milliseconds
Standard Deviation 9.03
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcF Interval, Day 9 post-dose, n= 15
|
7.9 Milliseconds
Standard Deviation 8.53
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcB Interval, Day 1, 2 hours post-dose, n= 16
|
0.7 Milliseconds
Standard Deviation 8.83
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcB Interval, Day 1, 4 hours post-dose, n= 16
|
4.7 Milliseconds
Standard Deviation 8.49
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcB Interval, Day 4, Pre-dose, n= 15
|
5.5 Milliseconds
Standard Deviation 18.50
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcB Interval, Day 4, 2 hours post-dose, n= 15
|
2.5 Milliseconds
Standard Deviation 12.37
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcB Interval, Day 4, 4 hours post-dose, n= 15
|
4.3 Milliseconds
Standard Deviation 8.52
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcB Interval, Day 7, Pre-dose, n= 15
|
4.6 Milliseconds
Standard Deviation 16.31
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcB Interval, Day 7, 2 hours post-dose, n= 15
|
-3.2 Milliseconds
Standard Deviation 11.64
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcB Interval, Day 7, 4 hours post-dose, n= 15
|
-1.7 Milliseconds
Standard Deviation 12.06
|
—
|
|
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcB Interval, Day 9 post-dose, n= 15
|
10.3 Milliseconds
Standard Deviation 12.19
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dosePopulation: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
PR Interval, Baseline
|
161.3 Milliseconds
Standard Deviation 16.53
|
—
|
|
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
PR Interval, Day 1, 2 hours post-dose
|
162.8 Milliseconds
Standard Deviation 19.01
|
—
|
|
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
PR Interval, Day 1, 4 hours post-dose
|
159.4 Milliseconds
Standard Deviation 19.47
|
—
|
|
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QRS Duration, Baseline
|
91.0 Milliseconds
Standard Deviation 8.22
|
—
|
|
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QRS Duration, Day 1, 2 hours post-dose
|
89.9 Milliseconds
Standard Deviation 7.54
|
—
|
|
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QRS Duration, Day 1, 4 hours post-dose
|
91.3 Milliseconds
Standard Deviation 8.14
|
—
|
|
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QT Interval, Baseline
|
377.8 Milliseconds
Standard Deviation 24.84
|
—
|
|
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QT Interval, Day 1, 2 hours post-dose
|
370.3 Milliseconds
Standard Deviation 24.74
|
—
|
|
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QT Interval, Day 1, 4 hours post-dose
|
383.6 Milliseconds
Standard Deviation 32.12
|
—
|
|
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcF Interval, Baseline
|
391.6 Milliseconds
Standard Deviation 12.92
|
—
|
|
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcF Interval, Day 1, 2 hours post-dose
|
386.7 Milliseconds
Standard Deviation 14.33
|
—
|
|
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcF Interval, Day 1, 4 hours post-dose
|
390.3 Milliseconds
Standard Deviation 18.27
|
—
|
|
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcB Interval, Baseline
|
398.8 Milliseconds
Standard Deviation 11.28
|
—
|
|
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcB Interval, Day 1, 2 hours post-dose
|
394.6 Milliseconds
Standard Deviation 15.14
|
—
|
|
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcB Interval, Day 1, 4 hours post-dose
|
393.3 Milliseconds
Standard Deviation 18.26
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
PR Interval, Baseline, n= 16
|
167.3 Milliseconds
Standard Deviation 19.46
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
PR Interval, Day 1, 2 hours post-dose, n= 16
|
160.4 Milliseconds
Standard Deviation 19.73
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
PR Interval, Day 1, 4 hours post-dose, n= 16
|
163.6 Milliseconds
Standard Deviation 19.04
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
PR Interval, Day 4, Pre-dose, n= 15
|
167.1 Milliseconds
Standard Deviation 22.20
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
PR Interval, Day 4, 2 hours post-dose, n= 15
|
160.7 Milliseconds
Standard Deviation 19.59
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
PR Interval, Day 4, 4 hours post-dose, n= 15
|
163.7 Milliseconds
Standard Deviation 19.29
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
PR Interval, Day 7, Pre-dose, n= 15
|
164.9 Milliseconds
Standard Deviation 21.11
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
PR Interval, Day 7, 2 hours post-dose, n= 15
|
164.3 Milliseconds
Standard Deviation 20.95
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
PR Interval, Day 7, 4 hours post-dose, n= 15
|
163.9 Milliseconds
Standard Deviation 22.05
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
PR Interval, Day 9 post-dose, n= 15
|
168.8 Milliseconds
Standard Deviation 23.70
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QRS Duration, Baseline, n= 16
|
91.4 Milliseconds
Standard Deviation 7.87
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QRS Duration, Day 1, 2 hours post-dose, n= 16
|
88.9 Milliseconds
Standard Deviation 8.20
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QRS Duration, Day 1, 4 hours post-dose, n= 16
|
90.1 Milliseconds
Standard Deviation 7.66
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QRS Duration, Day 4, Pre-dose, n= 15
|
91.8 Milliseconds
Standard Deviation 8.37
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QRS Duration, Day 4, 2 hours post-dose, n= 15
|
91.8 Milliseconds
Standard Deviation 9.12
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QRS Duration, Day 4, 4 hours post-dose, n= 15
|
91.1 Milliseconds
Standard Deviation 8.51
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QRS Duration, Day 7, Pre-dose, n= 15
|
94.5 Milliseconds
Standard Deviation 8.25
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QRS Duration, Day 7, 2 hours post-dose, n= 15
|
92.7 Milliseconds
Standard Deviation 7.49
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QRS Duration, Day 7, 4 hours post-dose, n= 15
|
91.6 Milliseconds
Standard Deviation 7.23
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QRS Duration, Day 9 post-dose, n= 15
|
94.3 Milliseconds
Standard Deviation 8.17
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QT Interval, Baseline, n= 16
|
377.7 Milliseconds
Standard Deviation 22.66
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QT Interval, Day 1, 2 hours post-dose, n= 16
|
365.1 Milliseconds
Standard Deviation 23.71
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QT Interval, Day 1, 4 hours post-dose, n= 16
|
375.9 Milliseconds
Standard Deviation 30.14
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QT Interval, Day 4, Pre-dose, n= 15
|
385.6 Milliseconds
Standard Deviation 26.65
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QT Interval, Day 4, 2 hours post-dose, n= 15
|
371.5 Milliseconds
Standard Deviation 27.31
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QT Interval, Day 4, 4 hours post-dose, n= 15
|
383.9 Milliseconds
Standard Deviation 31.05
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QT Interval, Day 7, Pre-dose, n= 15
|
381.7 Milliseconds
Standard Deviation 22.25
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QT Interval, Day 7, 2 hours post-dose, n= 15
|
369.9 Milliseconds
Standard Deviation 25.66
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QT Interval, Day 7, 4 hours post-dose, n= 15
|
384.1 Milliseconds
Standard Deviation 30.53
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QT Interval, Day 9 post-dose, n= 15
|
382.4 Milliseconds
Standard Deviation 26.55
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcF Interval, Baseline, n= 16
|
390.0 Milliseconds
Standard Deviation 13.48
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcF Interval, Day 1, 2 hours, n= 16
|
385.6 Milliseconds
Standard Deviation 15.44
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcF Interval, Day 1, 4 hours post-dose, n= 16
|
392.4 Milliseconds
Standard Deviation 15.95
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcF Interval, Day 4, Pre-dose, n= 15
|
395.0 Milliseconds
Standard Deviation 21.88
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcF Interval, Day 4, 2 hours post-dose, n= 15
|
388.3 Milliseconds
Standard Deviation 17.56
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcF Interval, Day 4, 4 hours post-dose, n= 15
|
393.4 Milliseconds
Standard Deviation 18.97
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcF Interval, Day 7, Pre-dose, n= 15
|
393.0 Milliseconds
Standard Deviation 18.42
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcF Interval, Day 7, 2 hours post-dose, n= 15
|
383.8 Milliseconds
Standard Deviation 16.19
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcF Interval, Day 7, 4 hours post-dose, n= 15
|
389.5 Milliseconds
Standard Deviation 18.06
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcF Interval, Day 9 post-dose, n= 15
|
396.8 Milliseconds
Standard Deviation 18.51
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcB Interval, Baseline, n= 16
|
395.7 Milliseconds
Standard Deviation 14.19
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcB Interval, Day 1, 2 hours post-dose, n= 16
|
396.4 Milliseconds
Standard Deviation 17.29
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcB Interval, Day 1, 4 hours post-dose, n= 16
|
400.4 Milliseconds
Standard Deviation 16.20
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcB Interval, Day 4, Pre-dose, n= 15
|
399.2 Milliseconds
Standard Deviation 25.96
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcB Interval, Day 4, 2 hours post-dose, n= 15
|
396.2 Milliseconds
Standard Deviation 16.01
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcB Interval, Day 4, 4 hours post-dose, n= 15
|
398.0 Milliseconds
Standard Deviation 17.53
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcB Interval, Day 7, Pre-dose, n= 15
|
398.3 Milliseconds
Standard Deviation 23.83
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcB Interval, Day 7, 2 hours post-dose, n= 15
|
390.5 Milliseconds
Standard Deviation 13.31
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcB Interval, Day 7, 4 hours post-dose, n= 15
|
391.9 Milliseconds
Standard Deviation 16.35
|
—
|
|
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
QTcB Interval, Day 9 post-dose, n= 15
|
404.0 Milliseconds
Standard Deviation 20.62
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Change From Baseline in Temperature
Day 2
|
-0.16 Degree Celsius
Standard Deviation 0.400
|
—
|
|
Period 1: Change From Baseline in Temperature
Day 3
|
-0.15 Degree Celsius
Standard Deviation 0.576
|
—
|
|
Period 1: Change From Baseline in Temperature
Day 4
|
-0.09 Degree Celsius
Standard Deviation 0.406
|
—
|
|
Period 1: Change From Baseline in Temperature
Day 5
|
-0.15 Degree Celsius
Standard Deviation 0.371
|
—
|
|
Period 1: Change From Baseline in Temperature
Day 7
|
-0.24 Degree Celsius
Standard Deviation 0.491
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 4, 7, 9, and 10Population: Safety Population. Only those participants with data available at the specified time points
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.
Outcome measures
| Measure |
TAF/FTC
n=15 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Change From Baseline in Temperature
Day 4
|
-0.10 Degree Celsius
Standard Deviation 0.344
|
—
|
|
Period 2: Change From Baseline in Temperature
Day 7
|
-0.07 Degree Celsius
Standard Deviation 0.337
|
—
|
|
Period 2: Change From Baseline in Temperature
Day 9
|
-0.01 Degree Celsius
Standard Deviation 0.386
|
—
|
|
Period 2: Change From Baseline in Temperature
Day 10
|
0.07 Degree Celsius
Standard Deviation 0.320
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7Population: Safety Population
Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Absolute Values of Temperature
Baseline
|
36.49 Degree Celsius
Standard Deviation 0.298
|
—
|
|
Period 1: Absolute Values of Temperature
Day 2
|
36.33 Degree Celsius
Standard Deviation 0.342
|
—
|
|
Period 1: Absolute Values of Temperature
Day 3
|
36.34 Degree Celsius
Standard Deviation 0.456
|
—
|
|
Period 1: Absolute Values of Temperature
Day 4
|
36.41 Degree Celsius
Standard Deviation 0.431
|
—
|
|
Period 1: Absolute Values of Temperature
Day 5
|
36.34 Degree Celsius
Standard Deviation 0.360
|
—
|
|
Period 1: Absolute Values of Temperature
Day 7
|
36.25 Degree Celsius
Standard Deviation 0.407
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 4, 7, 9, and 10Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Absolute Values of Temperature
Baseline, n= 16
|
36.49 Degree Celsius
Standard Deviation 0.257
|
—
|
|
Period 2: Absolute Values of Temperature
Day 4, n=15
|
36.37 Degree Celsius
Standard Deviation 0.348
|
—
|
|
Period 2: Absolute Values of Temperature
Day 7, n=15
|
36.40 Degree Celsius
Standard Deviation 0.421
|
—
|
|
Period 2: Absolute Values of Temperature
Day 9, n=15
|
36.46 Degree Celsius
Standard Deviation 0.378
|
—
|
|
Period 2: Absolute Values of Temperature
Day 10, n=15
|
36.53 Degree Celsius
Standard Deviation 0.282
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Change From Baseline in Pulse Rate
Day 2
|
-1.2 Beats per minute
Standard Deviation 9.77
|
—
|
|
Period 1: Change From Baseline in Pulse Rate
Day 3
|
-3.8 Beats per minute
Standard Deviation 9.94
|
—
|
|
Period 1: Change From Baseline in Pulse Rate
Day 4
|
-4.0 Beats per minute
Standard Deviation 9.67
|
—
|
|
Period 1: Change From Baseline in Pulse Rate
Day 5
|
-1.6 Beats per minute
Standard Deviation 10.47
|
—
|
|
Period 1: Change From Baseline in Pulse Rate
Day 7
|
-7.6 Beats per minute
Standard Deviation 7.83
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 4, 7, 9, and 10Population: Safety Population. Only those participants with data available at the specified time points
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.
Outcome measures
| Measure |
TAF/FTC
n=15 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Change From Baseline in Pulse Rate
Day 4
|
2.4 Beats per minute
Standard Deviation 18.62
|
—
|
|
Period 2: Change From Baseline in Pulse Rate
Day 7
|
1.9 Beats per minute
Standard Deviation 15.62
|
—
|
|
Period 2: Change From Baseline in Pulse Rate
Day 9
|
-0.3 Beats per minute
Standard Deviation 10.20
|
—
|
|
Period 2: Change From Baseline in Pulse Rate
Day 10
|
9.5 Beats per minute
Standard Deviation 11.12
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Absolute Values of Pulse Rate
Baseline
|
73.9 Beats per minute
Standard Deviation 9.24
|
—
|
|
Period 1: Absolute Values of Pulse Rate
Day 2
|
72.8 Beats per minute
Standard Deviation 10.14
|
—
|
|
Period 1: Absolute Values of Pulse Rate
Day 3
|
70.1 Beats per minute
Standard Deviation 11.18
|
—
|
|
Period 1: Absolute Values of Pulse Rate
Day 4
|
69.9 Beats per minute
Standard Deviation 10.81
|
—
|
|
Period 1: Absolute Values of Pulse Rate
Day 5
|
72.3 Beats per minute
Standard Deviation 12.38
|
—
|
|
Period 1: Absolute Values of Pulse Rate
Day 7
|
66.3 Beats per minute
Standard Deviation 10.20
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 4, 7, 9, and 10Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Absolute Values of Pulse Rate
Baseline, n= 16
|
70.5 Beats per minute
Standard Deviation 11.33
|
—
|
|
Period 2: Absolute Values of Pulse Rate
Day 4, n=15
|
71.9 Beats per minute
Standard Deviation 18.39
|
—
|
|
Period 2: Absolute Values of Pulse Rate
Day 7, n=15
|
71.4 Beats per minute
Standard Deviation 14.73
|
—
|
|
Period 2: Absolute Values of Pulse Rate
Day 9, n=15
|
69.2 Beats per minute
Standard Deviation 10.73
|
—
|
|
Period 2: Absolute Values of Pulse Rate
Day 10, n=15
|
79.0 Beats per minute
Standard Deviation 12.45
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Change From Baseline in Respiratory Rate
Day 2
|
-1.5 Breaths per minute
Standard Deviation 2.00
|
—
|
|
Period 1: Change From Baseline in Respiratory Rate
Day 3
|
-0.5 Breaths per minute
Standard Deviation 3.14
|
—
|
|
Period 1: Change From Baseline in Respiratory Rate
Day 4
|
-0.5 Breaths per minute
Standard Deviation 2.37
|
—
|
|
Period 1: Change From Baseline in Respiratory Rate
Day 5
|
1.3 Breaths per minute
Standard Deviation 2.52
|
—
|
|
Period 1: Change From Baseline in Respiratory Rate
Day 7
|
0.6 Breaths per minute
Standard Deviation 3.24
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 4, 7, 9, and 10Population: Safety Population. Only those participants with data available at the specified time points
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.
Outcome measures
| Measure |
TAF/FTC
n=15 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Change From Baseline in Respiratory Rate
Day 4
|
-3.2 Breaths per minute
Standard Deviation 3.61
|
—
|
|
Period 2: Change From Baseline in Respiratory Rate
Day 7
|
-2.4 Breaths per minute
Standard Deviation 2.85
|
—
|
|
Period 2: Change From Baseline in Respiratory Rate
Day 9
|
-0.8 Breaths per minute
Standard Deviation 2.11
|
—
|
|
Period 2: Change From Baseline in Respiratory Rate
Day 10
|
-1.5 Breaths per minute
Standard Deviation 2.33
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7Population: Safety Population
Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Absolute Values of Respiratory Rate
Baseline
|
14.0 Breaths per minute
Standard Deviation 1.63
|
—
|
|
Period 1: Absolute Values of Respiratory Rate
Day 2
|
12.5 Breaths per minute
Standard Deviation 1.37
|
—
|
|
Period 1: Absolute Values of Respiratory Rate
Day 3
|
13.5 Breaths per minute
Standard Deviation 2.48
|
—
|
|
Period 1: Absolute Values of Respiratory Rate
Day 4
|
13.5 Breaths per minute
Standard Deviation 2.00
|
—
|
|
Period 1: Absolute Values of Respiratory Rate
Day 5
|
15.3 Breaths per minute
Standard Deviation 2.05
|
—
|
|
Period 1: Absolute Values of Respiratory Rate
Day 7
|
14.6 Breaths per minute
Standard Deviation 2.70
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 4, 7, 9, and 10Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Absolute Values of Respiratory Rate
Day 9, n=15
|
14.9 Breaths per minute
Standard Deviation 1.49
|
—
|
|
Period 2: Absolute Values of Respiratory Rate
Baseline, n= 16
|
15.6 Breaths per minute
Standard Deviation 2.22
|
—
|
|
Period 2: Absolute Values of Respiratory Rate
Day 4, n=15
|
12.5 Breaths per minute
Standard Deviation 2.67
|
—
|
|
Period 2: Absolute Values of Respiratory Rate
Day 7, n=15
|
13.3 Breaths per minute
Standard Deviation 2.35
|
—
|
|
Period 2: Absolute Values of Respiratory Rate
Day 10, n=15
|
14.3 Breaths per minute
Standard Deviation 1.49
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Change From Baseline in Blood Pressure
SBP, Day 2
|
1.4 Millimeters of mercury
Standard Deviation 8.96
|
—
|
|
Period 1: Change From Baseline in Blood Pressure
SBP, Day 3
|
-1.8 Millimeters of mercury
Standard Deviation 8.54
|
—
|
|
Period 1: Change From Baseline in Blood Pressure
SBP, Day 4
|
-2.7 Millimeters of mercury
Standard Deviation 6.16
|
—
|
|
Period 1: Change From Baseline in Blood Pressure
SBP, Day 5
|
-2.3 Millimeters of mercury
Standard Deviation 8.81
|
—
|
|
Period 1: Change From Baseline in Blood Pressure
SBP, Day 7
|
0.8 Millimeters of mercury
Standard Deviation 9.47
|
—
|
|
Period 1: Change From Baseline in Blood Pressure
DBP, Day 2
|
0.1 Millimeters of mercury
Standard Deviation 8.33
|
—
|
|
Period 1: Change From Baseline in Blood Pressure
DBP, Day 3
|
-1.6 Millimeters of mercury
Standard Deviation 7.20
|
—
|
|
Period 1: Change From Baseline in Blood Pressure
DBP, Day 4
|
0.1 Millimeters of mercury
Standard Deviation 7.89
|
—
|
|
Period 1: Change From Baseline in Blood Pressure
DBP, Day 5
|
-1.4 Millimeters of mercury
Standard Deviation 6.20
|
—
|
|
Period 1: Change From Baseline in Blood Pressure
DBP, Day 7
|
2.9 Millimeters of mercury
Standard Deviation 7.58
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 4, 7, 9, and 10Population: Safety Population. Only those participants with data available at the specified time points
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.
Outcome measures
| Measure |
TAF/FTC
n=15 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Change From Baseline in Blood Pressure
SBP, Day 4
|
-0.3 Millimeters of mercury
Standard Deviation 5.07
|
—
|
|
Period 2: Change From Baseline in Blood Pressure
SBP, Day 7
|
1.1 Millimeters of mercury
Standard Deviation 8.95
|
—
|
|
Period 2: Change From Baseline in Blood Pressure
SBP, Day 9
|
-1.7 Millimeters of mercury
Standard Deviation 6.91
|
—
|
|
Period 2: Change From Baseline in Blood Pressure
SBP, Day 10
|
4.1 Millimeters of mercury
Standard Deviation 7.79
|
—
|
|
Period 2: Change From Baseline in Blood Pressure
DBP, Day 4
|
0.1 Millimeters of mercury
Standard Deviation 4.96
|
—
|
|
Period 2: Change From Baseline in Blood Pressure
DBP, Day 7
|
3.7 Millimeters of mercury
Standard Deviation 5.70
|
—
|
|
Period 2: Change From Baseline in Blood Pressure
DBP, Day 9
|
-4.0 Millimeters of mercury
Standard Deviation 5.26
|
—
|
|
Period 2: Change From Baseline in Blood Pressure
DBP, Day 10
|
-2.1 Millimeters of mercury
Standard Deviation 8.18
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7Population: Safety Population
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Absolute Values of Blood Pressure
SBP, Baseline
|
123.3 Millimeters of mercury
Standard Deviation 8.27
|
—
|
|
Period 1: Absolute Values of Blood Pressure
SBP, Day 2
|
124.7 Millimeters of mercury
Standard Deviation 9.60
|
—
|
|
Period 1: Absolute Values of Blood Pressure
SBP, Day 3
|
121.5 Millimeters of mercury
Standard Deviation 7.70
|
—
|
|
Period 1: Absolute Values of Blood Pressure
SBP, Day 4
|
120.6 Millimeters of mercury
Standard Deviation 8.47
|
—
|
|
Period 1: Absolute Values of Blood Pressure
SBP, Day 5
|
121.0 Millimeters of mercury
Standard Deviation 6.95
|
—
|
|
Period 1: Absolute Values of Blood Pressure
SBP, Day 7
|
124.1 Millimeters of mercury
Standard Deviation 10.56
|
—
|
|
Period 1: Absolute Values of Blood Pressure
DBP, Baseline
|
75.3 Millimeters of mercury
Standard Deviation 5.22
|
—
|
|
Period 1: Absolute Values of Blood Pressure
DBP, Day 2
|
75.4 Millimeters of mercury
Standard Deviation 9.08
|
—
|
|
Period 1: Absolute Values of Blood Pressure
DBP, Day 3
|
73.8 Millimeters of mercury
Standard Deviation 5.69
|
—
|
|
Period 1: Absolute Values of Blood Pressure
DBP, Day 4
|
75.4 Millimeters of mercury
Standard Deviation 10.42
|
—
|
|
Period 1: Absolute Values of Blood Pressure
DBP, Day 5
|
73.9 Millimeters of mercury
Standard Deviation 5.46
|
—
|
|
Period 1: Absolute Values of Blood Pressure
DBP, Day 7
|
78.2 Millimeters of mercury
Standard Deviation 7.57
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 4, 7, 9, and 10Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Absolute Values of Blood Pressure
SBP, Baseline, n= 16
|
120.4 Millimeters of mercury
Standard Deviation 7.27
|
—
|
|
Period 2: Absolute Values of Blood Pressure
SBP, Day 4, n=15
|
119.3 Millimeters of mercury
Standard Deviation 7.03
|
—
|
|
Period 2: Absolute Values of Blood Pressure
SBP, Day 7, n=15
|
120.8 Millimeters of mercury
Standard Deviation 10.58
|
—
|
|
Period 2: Absolute Values of Blood Pressure
SBP, Day 9, n=15
|
117.9 Millimeters of mercury
Standard Deviation 7.42
|
—
|
|
Period 2: Absolute Values of Blood Pressure
SBP, Day 10, n=15
|
123.7 Millimeters of mercury
Standard Deviation 8.52
|
—
|
|
Period 2: Absolute Values of Blood Pressure
DBP, Baseline, n= 16
|
74.4 Millimeters of mercury
Standard Deviation 6.14
|
—
|
|
Period 2: Absolute Values of Blood Pressure
DBP, Day 4, n= 15
|
74.3 Millimeters of mercury
Standard Deviation 5.16
|
—
|
|
Period 2: Absolute Values of Blood Pressure
DBP, Day 7, n= 15
|
77.9 Millimeters of mercury
Standard Deviation 8.98
|
—
|
|
Period 2: Absolute Values of Blood Pressure
DBP, Day 9, n= 15
|
70.3 Millimeters of mercury
Standard Deviation 7.36
|
—
|
|
Period 2: Absolute Values of Blood Pressure
DBP, Day 10, n= 15
|
72.1 Millimeters of mercury
Standard Deviation 6.41
|
—
|
SECONDARY outcome
Timeframe: 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 7Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=15 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: AUC (0-tau) of GSK3640254
|
24.53 Hours*nanogram per milliliter
Geometric Coefficient of Variation 26.5
|
—
|
SECONDARY outcome
Timeframe: 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 7Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=15 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Cmax of GSK3640254
|
1.411 Nanogram per milliliter
Geometric Coefficient of Variation 26.4
|
—
|
SECONDARY outcome
Timeframe: 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 7Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=15 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Ctau of GSK3640254
|
0.7883 Nanogram per milliliter
Geometric Coefficient of Variation 30.3
|
—
|
SECONDARY outcome
Timeframe: 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 7Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=15 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254
|
5.000 Hours
Interval 2.5 to 8.0
|
—
|
SECONDARY outcome
Timeframe: 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 14Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Tmax of TAF
|
1.00 Hours
Interval 0.5 to 2.0
|
—
|
SECONDARY outcome
Timeframe: 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 7Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=15 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Tmax of TAF
|
1.000 Hours
Interval 0.5 to 2.0
|
—
|
SECONDARY outcome
Timeframe: 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 14Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Tmax of FTC
|
1.500 Hours
Interval 1.0 to 3.0
|
—
|
SECONDARY outcome
Timeframe: 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 7Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=15 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Tmax of FTC
|
1.500 Hours
Interval 1.0 to 3.08
|
—
|
SECONDARY outcome
Timeframe: 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 14Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=16 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 1: Tmax of TFV
|
3.000 Hours
Interval 1.5 to 4.0
|
—
|
SECONDARY outcome
Timeframe: 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 7Population: PK Parameter Population
Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
TAF/FTC
n=15 Participants
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Period 2: Tmax of TFV
|
3.000 Hours
Interval 1.0 to 5.0
|
—
|
Adverse Events
TAF/FTC
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
TAF/FTC+GSK3640254
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TAF/FTC
n=16 participants at risk
Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
|
TAF/FTC+GSK3640254
n=16 participants at risk
In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
18.8%
3/16 • Number of events 3 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Rash pustular
|
12.5%
2/16 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Conjunctivitis
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
2/16 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/16 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/16 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
|
Immune system disorders
Seasonal allergy
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Abnormal dreams
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER