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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03836729
Recruitment Status : Completed
First Posted : February 11, 2019
Results First Posted : April 2, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Tenofovir alafenamide/emtricitabine
Drug: GSK3640254
Enrollment 16
Recruitment Details 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).
Pre-assignment Details A total of 16 participants were enrolled in the study.
Arm/Group Title TAF/FTC Followed by TAF/FTC+GSK3640254
Hide Arm/Group Description 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.
Period Title: Treatment Period 1 (Up to Day 14)
Started 16
Completed 16
Not Completed 0
Period Title: Treatment Period 2 (Up to Day 7)
Started 16
Completed 15
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title TAF/FTC Followed by TAF/FTC+GSK3640254
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
33.9  (9.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
0
   0.0%
Male
16
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants
American Indian or Alaska Native 1
Asian: East Asian Heritage 1
Black or African American 7
Native Hawaiian or other pacific islander 1
White:White/Caucasian/European Heritage 6
1.Primary Outcome
Title 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
Hide Description Blood samples were collected at indicated time-points for analysis of AUC (0-tau). Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. PK Parameter Population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated.
Time Frame Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*nanogram per milliliter
250.4
(58.2%)
2.Primary Outcome
Title Period 2: AUC (0-tau) of TAF
Hide Description Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.
Time Frame Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*nanogram per milliliter
215.4
(36.3%)
3.Primary Outcome
Title Period 1: Maximum Observed Concentration (Cmax) of TAF
Hide Description Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
Time Frame Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram per milliliter
203.4
(56.1%)
4.Primary Outcome
Title Period 2: Cmax of TAF
Hide Description Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
Time Frame Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram per milliliter
175.1
(44.4%)
5.Primary Outcome
Title Period 1: AUC (0-tau) of FTC
Hide Description Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.
Time Frame Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*nanogram per milliliter
9787.5
(15.5%)
6.Primary Outcome
Title Period 2: AUC (0-tau) of FTC
Hide Description Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.
Time Frame Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*nanogram per milliliter
9421.0
(14.4%)
7.Primary Outcome
Title Period 1:Cmax of FTC
Hide Description Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
Time Frame Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram per milliliter
1811
(15.9%)
8.Primary Outcome
Title Period 2:Cmax of FTC
Hide Description Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
Time Frame Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram per milliliter
1701
(20.9%)
9.Primary Outcome
Title Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of FTC
Hide Description Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.
Time Frame Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram per milliliter
71.81
(25.5%)
10.Primary Outcome
Title Period 2: Ctau of FTC
Hide Description Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.
Time Frame Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram per milliliter
82.92
(29.1%)
11.Primary Outcome
Title Period 1: AUC (0-tau) of Tenofovir (TFV)
Hide Description Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.
Time Frame Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*nanogram per milliliter
221.9
(18.3%)
12.Primary Outcome
Title Period 2: AUC (0-tau) of TFV
Hide Description Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.
Time Frame Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*nanogram per milliliter
229.1
(21.5%)
13.Primary Outcome
Title Period 1: Cmax of TFV
Hide Description Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
Time Frame Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram per milliliter
13.14
(17.8%)
14.Primary Outcome
Title Period 2: Cmax of TFV
Hide Description Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
Time Frame Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram per milliliter
13.30
(20.8%)
15.Primary Outcome
Title Period 1: Ctau of TFV
Hide Description Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.
Time Frame Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram per milliliter
7.688
(20.4%)
16.Primary Outcome
Title Period 2: Ctau of TFV
Hide Description Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.
Time Frame Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram per milliliter
8.244
(22.9%)
17.Secondary Outcome
Title Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE)
Hide Description An adverse events (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before
Time Frame Up to Day 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who received at least 1 dose of study medication.
Arm/Group Title TAF/FTC TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 16 15
Measure Type: Number
Unit of Measure: Participants
Non-SAEs 9 3
SAEs 0 0
18.Secondary Outcome
Title Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Hide Description Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 7, and 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Giga cells per liter
Basophils, Period 1 Day 7 -0.005  (0.0167)
Basophils, Period 1 Day 14 -0.006  (0.0260)
Eosinophils, Period 1 Day 7 -0.021  (0.0795)
Eosinophils, Period 1 Day 14 -0.020  (0.1531)
Monocytes, Period 1 Day 7 0.014  (0.1808)
Monocytes, Period 1 Day 14 0.049  (0.2718)
Leukocytes, Period 1 Day 7 -0.08  (1.795)
Leukocytes, Period 1 Day 14 0.27  (2.191)
Lymphocytes, Period 1 Day 7 -0.246  (0.3089)
Lymphocytes, Period 1 Day 14 -0.262  (0.4138)
Neutrophils, Period 1 Day 7 0.188  (1.5473)
Neutrophils, Period 1 Day 14 0.513  (1.7986)
Platelets, Period 1 Day 7 3.3  (21.23)
Platelets, Period 1 Day 14 21.8  (35.37)
19.Secondary Outcome
Title Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Hide Description Blood samples were collected at indicated timepoints for analysis for hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Giga cells per liter
Basophils, Period 2 Day 3, n= 15 Number Analyzed 15 participants
-0.004  (0.0196)
Basophils, Period 2 Day 7, n= 15 Number Analyzed 15 participants
-0.002  (0.0204)
Basophils, Period 2 Day 9, n= 15 Number Analyzed 15 participants
0.003  (0.0150)
Eosinophils, Period 2 Day 3, n=15 Number Analyzed 15 participants
-0.023  (0.0811)
Eosinophils, Period 2 Day 7, n=15 Number Analyzed 15 participants
-0.039  (0.1058)
Eosinophils, Period 2 Day 9, n=16 Number Analyzed 16 participants
-0.043  (0.1093)
Monocytes, Period 2 Day 3, n= 16 Number Analyzed 16 participants
-0.053  (0.1895)
Monocytes, Period 2 Day 7, n= 15 Number Analyzed 15 participants
-0.077  (0.1709)
Monocytes, Period 2 Day 9, n= 15 Number Analyzed 15 participants
-0.104  (0.1672)
Leukocytes, Period 2 Day 3, n= 16 Number Analyzed 16 participants
-1.06  (1.188)
Leukocytes, Period 2 Day 7, n= 15 Number Analyzed 15 participants
-0.61  (1.050)
Leukocytes, Period 2 Day 9, n= 15 Number Analyzed 15 participants
-0.49  (1.193)
Lymphocytes, Period 2 Day 3, n= 16 Number Analyzed 16 participants
-0.158  (0.2296)
Lymphocytes, Period 2 Day 7, n= 15 Number Analyzed 15 participants
-0.105  (0.2306)
Lymphocytes, Period 2 Day 9, n= 15 Number Analyzed 15 participants
-0.111  (0.2728)
Neutrophils, Period 2 Day 3, n= 16 Number Analyzed 16 participants
-0.868  (0.9597)
Neutrophils, Period 2 Day 7, n= 15 Number Analyzed 15 participants
-0.417  (0.9069)
Neutrophils, Period 2 Day 9, n= 15 Number Analyzed 15 participants
-0.282  (1.0161)
Platelets, Period 2 Day 3, n= 16 Number Analyzed 16 participants
9.2  (20.41)
Platelets, Period 2 Day 7, n= 15 Number Analyzed 15 participants
19.8  (43.02)
Platelets, Period 2 Day 9, n= 15 Number Analyzed 15 participants
16.2  (38.11)
20.Secondary Outcome
Title Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Hide Description Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Day -1 for Period 1.
Time Frame Baseline and at Days 7, and 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Giga cells per liter
Basophils, Period 1 Baseline 0.046  (0.0216)
Basophils, Period 1 Day 7 0.041  (0.0189)
Basophils, Period 1 Day 14 0.040  (0.0256)
Eosinophils, Period 1 Baseline 0.225  (0.1918)
Eosinophils, Period 1 Day 7 0.204  (0.1737)
Eosinophils, Period 1 Day 14 0.205  (0.1766)
Monocytes, Period 1 Baseline 0.522  (0.1147)
Monocytes, Period 1 Day 7 0.536  (0.2063)
Monocytes, Period 1 Day 14 0.571  (0.2830)
Leukocytes, Period 1 Baseline 6.18  (1.336)
Leukocytes, Period 1 Day 7 6.10  (2.024)
Leukocytes, Period 1 Day 14 6.45  (2.231)
Lymphocytes, Period 1 Baseline 1.945  (0.7419)
Lymphocytes, Period 1 Day 7 1.699  (0.5822)
Lymphocytes, Period 1 Day 14 1.683  (0.4988)
Neutrophils, Period 1 Baseline 3.441  (0.9719)
Neutrophils, Period 1 Day 7 3.628  (1.9503)
Neutrophils, Period 1 Day 14 3.954  (1.9141)
Platelets, Period 1 Baseline 253.3  (49.81)
Platelets, Period 1 Day 7 256.6  (49.72)
Platelets, Period 1 Day 14 275.1  (53.39)
21.Secondary Outcome
Title Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Hide Description Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Giga cells per liter
Basophils, Period 2 Baseline, n= 16 Number Analyzed 16 participants
0.040  (0.0256)
Basophils, Period 2 Day 3, n= 15 Number Analyzed 15 participants
0.036  (0.0182)
Basophils, Period 2 Day 7, n= 15 Number Analyzed 15 participants
0.038  (0.0152)
Basophils, Period 2 Day 9, n= 15 Number Analyzed 15 participants
0.043  (0.0232)
Eosinophils, Period 2 Baseline, n= 16 Number Analyzed 16 participants
0.208  (0.1764)
Eosinophils, Period 2 Day 3, n= 15 Number Analyzed 15 participants
0.185  (0.1533)
Eosinophils, Period 2 Day 7, n= 15 Number Analyzed 15 participants
0.157  (0.1405)
Eosinophils, Period 2 Day 9, n= 16 Number Analyzed 16 participants
0.153  (0.1384)
Monocytes, Period 2 Baseline, n= 16 Number Analyzed 16 participants
0.545  (0.2127)
Monocytes, Period 2 Day 3, n= 16 Number Analyzed 16 participants
0.492  (0.1975)
Monocytes, Period 2 Day 7, n= 15 Number Analyzed 15 participants
0.448  (0.1472)
Monocytes, Period 2 Day 9, n= 15 Number Analyzed 15 participants
0.421  (0.1212)
Leukocytes, Period 2 Baseline, n= 16 Number Analyzed 16 participants
6.20  (1.752)
Leukocytes, Period 2 Day 3, n= 16 Number Analyzed 16 participants
5.14  (1.035)
Leukocytes, Period 2 Day 7, n= 15 Number Analyzed 15 participants
5.39  (1.311)
Leukocytes, Period 2 Day 9, n= 15 Number Analyzed 15 participants
5.51  (1.415)
Lymphocytes, Period 2 Baseline, n= 16 Number Analyzed 16 participants
1.718  (0.4814)
Lymphocytes, Period 2 Day 3, n= 16 Number Analyzed 16 participants
1.560  (0.3786)
Lymphocytes, Period 2 Day 7, n= 15 Number Analyzed 15 participants
1.570  (0.4116)
Lymphocytes, Period 2 Day 9, n= 15 Number Analyzed 15 participants
1.563  (0.4236)
Neutrophils, Period 2 Baseline, n= 16 Number Analyzed 16 participants
3.724  (1.3787)
Neutrophils, Period 2 Day 3, n= 16 Number Analyzed 16 participants
2.857  (0.8106)
Neutrophils, Period 2 Day 7, n= 15 Number Analyzed 15 participants
3.189  (1.0515)
Neutrophils, Period 2 Day 9, n= 15 Number Analyzed 15 participants
3.324  (1.1988)
Platelets, Period 2 Baseline, n= 16 Number Analyzed 16 participants
274.3  (51.10)
Platelets, Period 2 Day 3, n= 16 Number Analyzed 16 participants
283.4  (54.62)
Platelets, Period 2 Day 7, n= 15 Number Analyzed 15 participants
294.0  (54.62)
Platelets, Period 2 Day 9, n= 15 Number Analyzed 15 participants
290.4  (73.92)
22.Secondary Outcome
Title Period 1: Change From Baseline in Hematology Parameter of Hematocrit
Hide Description Blood samples were collected at indicated timepoints for analysis of hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Proportion of red blood cells in blood
Day 7 0.0121  (0.01389)
Day 14 0.0189  (0.01304)
23.Secondary Outcome
Title Period 2: Change From Baseline in Hematology Parameter of Hematocrit
Hide Description Blood samples were collected at indicated time-points for analysis for hematology parameter like hematocrit. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Proportion of red blood cells in blood
Day 3, n= 16 Number Analyzed 16 participants
-0.0147  (0.00982)
Day 7, n= 15 Number Analyzed 15 participants
-0.0007  (0.01369)
Day 9, n= 15 Number Analyzed 15 participants
-0.0204  (0.01371)
24.Secondary Outcome
Title Period 1: Absolute Values of the Hematology Parameter: Hematocrit
Hide Description Blood samples were collected at indicated time points for analysis for hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Proportion of red blood cells in blood
Baseline 0.4264  (0.01891)
Day 7 0.4384  (0.02358)
Day 14 0.4453  (0.01997)
25.Secondary Outcome
Title Period 2: Absolute Values of the Hematology Parameter: Hematocrit
Hide Description Blood samples were collected at indicated time-points for analysis for hematology parameter like hematocrit. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Proportion of red blood cells in blood
Baseline, n= 16 Number Analyzed 16 participants
0.4453  (0.01997)
Day 3, n= 16 Number Analyzed 16 participants
0.4306  (0.01780)
Day 7, n= 15 Number Analyzed 15 participants
0.4444  (0.02234)
Day 9, n= 15 Number Analyzed 15 participants
0.4247  (0.01518)
26.Secondary Outcome
Title Period 1: Change From Baseline in Hematology Parameter of Hemoglobin
Hide Description Blood samples were collected at indicated timepoints for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Grams per liter
Day 7 6.1  (4.51)
Day 14 8.4  (3.98)
27.Secondary Outcome
Title Period 2: Change From Baseline in Hematology Parameter of Hemoglobin
Hide Description Blood samples were collected at indicated timepoints for analysis of hematology parameter like hemoglobin. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Grams per liter
Day 3, n= 16 Number Analyzed 16 participants
-3.9  (3.51)
Day 7, n= 15 Number Analyzed 15 participants
-1.1  (4.58)
Day 9, n= 15 Number Analyzed 15 participants
-6.4  (5.55)
28.Secondary Outcome
Title Period 1: Absolute Values of the Hematology Parameter: Hemoglobin
Hide Description Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Grams per liter
Baseline 142.0  (6.70)
Day 7 148.1  (8.11)
Day 14 150.4  (7.45)
29.Secondary Outcome
Title Period 2: Absolute Values of the Hematology Parameter: Hemoglobin
Hide Description Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Grams per liter
Baseline, n= 16 Number Analyzed 16 participants
150.4  (7.45)
Day 3, n= 16 Number Analyzed 16 participants
146.4  (6.37)
Day 7, n= 15 Number Analyzed 15 participants
149.1  (7.26)
Day 9, n= 15 Number Analyzed 15 participants
143.9  (5.19)
30.Secondary Outcome
Title Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH)
Hide Description Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCH. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Picograms
Day 7 0.13  (0.272)
Day 14 0.36  (0.276)
31.Secondary Outcome
Title Period 2: Change From Baseline in Hematology Parameter of MCH
Hide Description Blood samples were collected at indicated timepoints for analysis for hematology parameter like MCH. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Picograms
Day 3, n= 16 Number Analyzed 16 participants
-0.11  (0.205)
Day 7, n= 15 Number Analyzed 15 participants
-0.21  (0.203)
Day 9, n= 15 Number Analyzed 15 participants
-0.17  (0.253)
32.Secondary Outcome
Title Period 1: Absolute Values of the Hematology Parameter: MCH
Hide Description Blood samples were collected at indicated time-points for analysis for hematology parameter like MCH. Baseline was defined as Day -1 for Period 1.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Picograms
Baseline 28.63  (1.780)
Day 7 28.75  (1.687)
Day 14 28.98  (1.690)
33.Secondary Outcome
Title Period 2: Absolute Values of the Hematology Parameter: MCH
Hide Description Blood samples were collected at indicated time-points for analysis of hematology parameter like MCH. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Picograms
Baseline, n= 16 Number Analyzed 16 participants
28.98  (1.690)
Day 3, n= 16 Number Analyzed 16 participants
28.88  (1.699)
Day 7, n= 15 Number Analyzed 15 participants
28.83  (1.630)
Day 9, n= 15 Number Analyzed 15 participants
28.87  (1.702)
34.Secondary Outcome
Title Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV)
Hide Description Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Femtoliters
Day 7 -0.83  (0.620)
Day 14 -0.07  (0.712)
35.Secondary Outcome
Title Period 2: Change From Baseline in Hematology Parameter of MCV
Hide Description Blood samples were collected at indicated timepoints for analysis for hematology parameter like MCV. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Femtoliters
Day 3, n= 16 Number Analyzed 16 participants
-1.02  (0.483)
Day 7, n= 15 Number Analyzed 15 participants
-0.17  (0.472)
Day 9, n= 15 Number Analyzed 15 participants
-0.82  (0.499)
36.Secondary Outcome
Title Period 1: Absolute Values of the Hematology Parameter: MCV
Hide Description Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Femtoliters
Baseline 85.92  (4.690)
Day 7 85.09  (4.504)
Day 14 85.85  (4.492)
37.Secondary Outcome
Title Period 2: Absolute Values of the Hematology Parameter: MCV
Hide Description Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Femtoliters
Baseline, n= 16 Number Analyzed 16 participants
85.85  (4.492)
Day 3, n= 16 Number Analyzed 16 participants
84.83  (4.490)
Day 7, n= 15 Number Analyzed 15 participants
85.85  (4.491)
Day 9, n= 15 Number Analyzed 15 participants
85.20  (4.601)
38.Secondary Outcome
Title Period 1: Change From Baseline in Hematology Parameter of Erythrocytes
Hide Description Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Trillion cells per liter
Day 7 0.189  (0.1485)
Day 14 0.226  (0.1360)
39.Secondary Outcome
Title Period 2: Change From Baseline in Hematology Parameter of Erythrocytes
Hide Description Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Trillion cells per liter
Day 3, n= 16 Number Analyzed 16 participants
-0.113  (0.1123)
Day 7, n= 15 Number Analyzed 15 participants
0.000  (0.1466)
Day 9, n= 15 Number Analyzed 15 participants
-0.189  (0.1697)
40.Secondary Outcome
Title Period 1: Absolute Values of the Hematology Parameter: Erythrocytes
Hide Description Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Trillion cells per liter
Baseline 4.977  (0.3351)
Day 7 5.166  (0.3679)
Day 14 5.203  (0.3604)
41.Secondary Outcome
Title Period 2: Absolute Values of the Hematology Parameter: Erythrocytes
Hide Description Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Trillion cells per liter
Baseline, n= 16 Number Analyzed 16 participants
5.203  (0.3604)
Day 3, n= 16 Number Analyzed 16 participants
5.090  (0.3395)
Day 7, n= 15 Number Analyzed 15 participants
5.190  (0.4087)
Day 9, n= 15 Number Analyzed 15 participants
5.001  (0.3446)
42.Secondary Outcome
Title 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
Hide Description Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Millimoles per Liter
Glucose, Day 7 -0.160  (0.3793)
Glucose, Day 14 -0.320  (0.3432)
Cholesterol, Day 7 -0.004  (0.3735)
Cholesterol, Day 14 -0.389  (0.3533)
Anion gap, Day 7 1.9  (2.08)
Anion gap, Day 14 2.2  (1.42)
Calcium, Day 7 0.028  (0.0780)
Calcium, Day 14 0.028  (0.0556)
CO2, Day 7 -1.6  (1.93)
CO2, Day 14 -0.9  (1.20)
Chloride, Day 7 -1.1  (1.06)
Chloride, Day 14 -2.0  (1.46)
Phosphate, Day 7 0.017  (0.0960)
Phosphate, Day 14 0.026  (0.1330)
Potassium, Day 7 0.03  (0.304)
Potassium, Day 14 -0.03  (0.328)
Sodium, Day 7 -0.6  (1.45)
Sodium, Day 14 -0.6  (1.59)
Triglycerides, Day 7 0.092  (0.4841)
Triglycerides, Day 14 -0.044  (0.4569)
BUN, Day 7 -0.018  (1.2157)
BUN, Day 14 -0.195  (1.0640)
43.Secondary Outcome
Title Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Hide Description Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Millimoles per Liter
Glucose, Day 3, n= 15 Number Analyzed 15 participants
0.236  (0.2463)
Glucose, Day 7, n= 15 Number Analyzed 15 participants
0.315  (0.3282)
Glucose, Day 9, n= 15 Number Analyzed 15 participants
0.136  (0.2433)
Cholesterol, Day 3, n=15 Number Analyzed 15 participants
0.011  (0.2372)
Cholesterol, Day 7, n= 15 Number Analyzed 15 participants
0.102  (0.3899)
Cholesterol, Day 9, n= 16 Number Analyzed 16 participants
0.030  (0.4594)
Anion gap, Day 3, n= 16 Number Analyzed 16 participants
-0.4  (1.82)
Anion gap, Day 7, n= 15 Number Analyzed 15 participants
-0.5  (1.73)
Anion gap, Day 9, n= 15 Number Analyzed 15 participants
-0.3  (1.67)
Calcium, Day 3, n= 16 Number Analyzed 16 participants
0.013  (0.0478)
Calcium, Day 7, n= 15 Number Analyzed 15 participants
0.037  (0.0568)
Calcium, Day 9, n= 15 Number Analyzed 15 participants
0.033  (0.0628)
CO2, Day 3, n= 16 Number Analyzed 16 participants
-0.5  (1.26)
CO2, Day 7, n= 15 Number Analyzed 15 participants
-0.1  (1.36)
CO2, Day 9, n= 15 Number Analyzed 15 participants
-0.4  (1.18)
Chloride, Day 3, n= 16 Number Analyzed 16 participants
2.3  (1.20)
Chloride, Day 7, n= 15 Number Analyzed 15 participants
0.6  (1.35)
Chloride, Day 9, n= 15 Number Analyzed 15 participants
1.3  (1.72)
Phosphate, Day 3, n= 16 Number Analyzed 16 participants
0.062  (0.0683)
Phosphate, Day 7, n= 15 Number Analyzed 15 participants
0.002  (0.0800)
Phosphate, Day 9, n= 15 Number Analyzed 15 participants
0.007  (0.0584)
Potassium, Day 3, n= 16 Number Analyzed 16 participants
0.01  (0.284)
Potassium, Day 7, n= 15 Number Analyzed 15 participants
-0.03  (0.213)
Potassium, Day 9, n= 15 Number Analyzed 15 participants
0.10  (0.344)
Sodium, Day 3, n= 16 Number Analyzed 16 participants
1.4  (1.36)
Sodium, Day 7, n= 15 Number Analyzed 15 participants
0.1  (1.53)
Sodium, Day 9, n= 15 Number Analyzed 15 participants
0.6  (1.06)
Triglycerides, Day 3, n= 16 Number Analyzed 16 participants
-0.003  (0.1753)
Triglycerides, Day 7, n= 15 Number Analyzed 15 participants
0.111  (0.2414)
Triglycerides, Day 9, n= 15 Number Analyzed 15 participants
-0.049  (0.2747)
BUN, Day 3, n= 16 Number Analyzed 16 participants
0.312  (0.5567)
BUN, Day 7, n= 15 Number Analyzed 15 participants
-0.031  (0.5038)
BUN, Day 9, n= 15 Number Analyzed 15 participants
-0.028  (0.4521)
44.Secondary Outcome
Title Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Hide Description Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Day -1 for Period 1.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Millimoles per Liter
Glucose, Baseline 5.111  (0.3747)
Glucose, Day 7 4.951  (0.2587)
Glucose, Day 14 4.791  (0.2662)
Cholesterol, Baseline 4.253  (0.7938)
Cholesterol, Day 7 4.249  (0.8494)
Cholesterol, Day 14 3.864  (0.6087)
Anion gap, Baseline 8.7  (1.08)
Anion gap, Day 7 10.6  (2.25)
Anion gap, Day 14 10.9  (1.45)
Calcium, Baseline 2.359  (0.0697)
Calcium, Day 7 2.387  (0.0663)
Calcium, Day 14 2.387  (0.0637)
CO2, Baseline 31.7  (1.49)
CO2, Day 7 30.1  (1.86)
CO2, Day 14 30.8  (1.38)
Chloride, Baseline 103.3  (1.84)
Chloride, Day 7 102.2  (1.72)
Chloride, Day 14 101.3  (2.32)
Phosphate, Baseline 1.078  (0.1301)
Phosphate, Day 7 1.094  (0.1202)
Phosphate, Day 14 1.103  (0.0807)
Potassium, Baseline 4.25  (0.225)
Potassium, Day 7 4.28  (0.161)
Potassium, Day 14 4.22  (0.279)
Sodium, Baseline 139.4  (1.45)
Sodium, Day 7 138.8  (1.77)
Sodium, Day 14 138.8  (1.69)
Triglycerides, Baseline 1.076  (0.5825)
Triglycerides, Day 7 1.168  (0.3759)
Triglycerides, Day 14 1.033  (0.3034)
BUN, Baseline 4.441  (1.2792)
BUN, Day 7 4.423  (0.9623)
BUN, Day 14 4.246  (0.7820)
45.Secondary Outcome
Title Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Hide Description Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Millimoles per Liter
Glucose, Baseline, n= 16 Number Analyzed 16 participants
4.791  (0.2662)
Glucose, Day 3, n= 15 Number Analyzed 15 participants
5.027  (0.2894)
Glucose, Day 7, n= 15 Number Analyzed 15 participants
5.129  (0.3388)
Glucose, Day 9, n= 15 Number Analyzed 15 participants
4.950  (0.3360)
Cholesterol, Baseline, n= 16 Number Analyzed 16 participants
3.864  (0.6087)
Cholesterol, Day 3, n=15 Number Analyzed 15 participants
3.875  (0.6509)
Cholesterol, Day 7, n= 15 Number Analyzed 15 participants
3.894  (0.7575)
Cholesterol, Day 9, n= 16 Number Analyzed 16 participants
3.822  (0.7838)
Anion gap, Baseline, n= 16 Number Analyzed 16 participants
10.9  (1.45)
Anion gap, Day 3, n= 16 Number Analyzed 16 participants
10.5  (1.37)
Anion gap, Day 7, n= 15 Number Analyzed 15 participants
10.3  (1.28)
Anion gap, Day 9, n= 15 Number Analyzed 15 participants
10.5  (0.74)
Calcium, Baseline, n= 16 Number Analyzed 16 participants
2.387  (0.0637)
Calcium, Day 3, n= 16 Number Analyzed 16 participants
2.399  (0.0682)
Calcium, Day 7, n= 15 Number Analyzed 15 participants
2.424  (0.0693)
Calcium, Day 9, n= 15 Number Analyzed 15 participants
2.421  (0.0670)
CO2, Baseline, n= 16 Number Analyzed 16 participants
30.8  (1.38)
CO2, Day 3, n= 16 Number Analyzed 16 participants
30.3  (1.96)
CO2, Day 7, n= 15 Number Analyzed 15 participants
30.7  (1.91)
CO2, Day 9, n= 15 Number Analyzed 15 participants
30.5  (1.30)
Chloride, Baseline, n= 16 Number Analyzed 16 participants
101.3  (2.32)
Chloride, Day 3, n= 16 Number Analyzed 16 participants
103.6  (1.50)
Chloride, Day 7, n= 15 Number Analyzed 15 participants
101.9  (1.62)
Chloride, Day 9, n= 15 Number Analyzed 15 participants
102.7  (1.50)
Phosphate, Baseline, n= 16 Number Analyzed 16 participants
1.103  (0.0807)
Phosphate, Day 3, n= 16 Number Analyzed 16 participants
1.165  (0.1007)
Phosphate, Day 7, n= 15 Number Analyzed 15 participants
1.112  (0.1097)
Phosphate, Day 9, n= 15 Number Analyzed 15 participants
1.117  (0.0952)
Potassium, Baseline, n= 16 Number Analyzed 16 participants
4.22  (0.279)
Potassium, Day 3, n= 16 Number Analyzed 16 participants
4.23  (0.241)
Potassium, Day 7, n= 15 Number Analyzed 15 participants
4.21  (0.236)
Potassium, Day 9, n= 15 Number Analyzed 15 participants
4.35  (0.226)
Sodium, Baseline, n= 16 Number Analyzed 16 participants
138.8  (1.69)
Sodium, Day 3, n= 16 Number Analyzed 16 participants
140.2  (1.56)
Sodium, Day 7, n= 15 Number Analyzed 15 participants
138.8  (1.42)
Sodium, Day 9, n=15 Number Analyzed 15 participants
139.3  (1.18)
Triglycerides, Baseline, n= 16 Number Analyzed 16 participants
1.033  (0.3034)
Triglycerides, Day 3, n= 16 Number Analyzed 16 participants
1.029  (0.3440)
Triglycerides, Day 7, n= 15 Number Analyzed 15 participants
1.120  (0.4358)
Triglycerides, Day 9, n= 15 Number Analyzed 15 participants
0.961  (0.4320)
BUN, Baseline, n= 16 Number Analyzed 16 participants
4.246  (0.7820)
BUN, Day 3, n= 16 Number Analyzed 16 participants
4.558  (0.8267)
BUN, Day 7, n= 15 Number Analyzed 15 participants
4.260  (0.8705)
BUN Day 9, n= 15 Number Analyzed 15 participants
4.263  (0.6977)
46.Secondary Outcome
Title 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)
Hide Description Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter like alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: International units per Liter
Alkaline phosphatase, Day 7 -2.6  (5.10)
Alkaline phosphatase, Day 14 2.4  (6.91)
AST, Day 7 -6.2  (4.59)
AST, Day 14 -6.9  (4.95)
ALT, Day 7 -2.1  (7.26)
ALT, Day 14 -6.2  (6.98)
GGT Day 7 0.2  (2.32)
GGT Day 14 -1.7  (3.63)
LDH, Day 7 -14.6  (13.07)
LDH, Day 14 -12.0  (16.25)
CK, Day 7 -103.0  (127.10)
CK, Day 14 -99.2  (135.80)
47.Secondary Outcome
Title Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
Hide Description Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: International units per Liter
Alkaline phosphatase, Day 3, n= 16 Number Analyzed 16 participants
3.7  (3.48)
Alkaline phosphatase, Day 7, n= 15 Number Analyzed 15 participants
2.6  (3.64)
Alkaline phosphatase, Day 9, n= 15 Number Analyzed 15 participants
-1.0  (3.98)
AST, Day 3, n= 16 Number Analyzed 16 participants
-1.4  (1.31)
AST, Day 7, n= 15 Number Analyzed 15 participants
-0.5  (2.45)
AST, Day 9, n= 15 Number Analyzed 15 participants
-0.1  (2.13)
ALT, Day 3, n= 16 Number Analyzed 16 participants
-2.0  (1.63)
ALT, Day 7, n= 15 Number Analyzed 15 participants
-1.9  (2.76)
ALT, Day 9, n= 15 Number Analyzed 15 participants
-0.7  (4.56)
GGT, Day 3, n= 16 Number Analyzed 16 participants
-0.9  (1.18)
GGT, Day 7, n= 15 Number Analyzed 15 participants
-1.4  (1.50)
GGT, Day 9, n= 15 Number Analyzed 15 participants
-1.9  (2.55)
LDH, Day 3, n= 16 Number Analyzed 16 participants
-7.0  (11.98)
LDH, Day 7, n= 15 Number Analyzed 15 participants
-8.2  (12.73)
LDH, Day 9, n= 15 Number Analyzed 15 participants
-7.0  (11.98)
CK, Day 3, n= 16 Number Analyzed 16 participants
3.4  (29.12)
CK, Day 7, n= 15 Number Analyzed 15 participants
11.3  (33.83)
CK, Day 9, n= 15 Number Analyzed 15 participants
-2.3  (22.65)
48.Secondary Outcome
Title Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
Hide Description Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Day -1 for Period 1.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: International units per Liter
Alkaline phosphatase, Baseline 60.9  (9.33)
Alkaline phosphatase, Day 7 58.3  (8.36)
Alkaline phosphatase, Day 14 63.4  (8.82)
AST, Baseline 24.6  (6.16)
AST, Day 7 18.4  (4.79)
AST, Day 14 17.6  (3.46)
ALT, Baseline 26.6  (10.44)
ALT, Day 7 24.4  (13.28)
ALT, Day 14 20.4  (8.59)
GGT Baseline 1.76  (1.016)
GGT Day 7 1.91  (0.752)
GGT Day 14 2.40  (1.035)
LDH, Baseline 138.0  (19.77)
LDH, Day 7 123.4  (19.67)
LDH, Day 9 126.0  (19.50)
CK, Baseline 219.6  (150.90)
CK, Day 7 116.6  (49.16)
CK, Day 14 120.4  (62.41)
49.Secondary Outcome
Title Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
Hide Description Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: International units per Liter
Alkaline phosphatase, Baseline Day 3, n= 16 Number Analyzed 16 participants
63.4  (8.82)
Alkaline phosphatase, Day 3, n= 16 Number Analyzed 16 participants
67.1  (10.45)
Alkaline phosphatase, Day 7, n= 15 Number Analyzed 15 participants
65.4  (9.81)
Alkaline phosphatase, Day 9, n= 15 Number Analyzed 15 participants
61.8  (9.65)
AST, Baseline, n= 16 Number Analyzed 16 participants
17.6  (3.46)
AST, Day 3, n= 16 Number Analyzed 16 participants
16.2  (3.04)
AST, Day 7, n= 15 Number Analyzed 15 participants
17.2  (3.38)
AST, Day 9, n= 15 Number Analyzed 15 participants
17.6  (3.83)
ALT, Baseline, n= 16 Number Analyzed 16 participants
20.4  (8.59)
ALT, Day 3, n= 16 Number Analyzed 16 participants
18.4  (7.87)
ALT, Day 7, n= 15 Number Analyzed 15 participants
18.5  (8.31)
ALT, Day 9, n= 15 Number Analyzed 15 participants
19.7  (9.43)
GGT, Baseline, n= 16 Number Analyzed 16 participants
2.40  (1.035)
GGT, Day 3, n= 16 Number Analyzed 16 participants
2.14  (1.065)
GGT, Day 7, n= 15 Number Analyzed 15 participants
2.41  (0.828)
GGT, Day 9, n= 15 Number Analyzed 15 participants
1.95  (0.673)
LDH, Baseline, n= 16 Number Analyzed 16 participants
126.0  (19.50)
LDH, Day 3, n= 16 Number Analyzed 16 participants
119.0  (19.37)
LDH, Day 7, n= 15 Number Analyzed 15 participants
118.0  (13.93)
LDH, Day 9, n= 15 Number Analyzed 15 participants
119.2  (17.70)
CK, Baseline, n= 16 Number Analyzed 16 participants
120.4  (62.41)
CK, Day 3, n= 16 Number Analyzed 16 participants
123.8  (51.53)
CK, Day 7, n= 15 Number Analyzed 15 participants
135.8  (66.33)
CK, Day 9, n= 15 Number Analyzed 15 participants
122.2  (54.94)
50.Secondary Outcome
Title Period 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase
Hide Description Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Units per Liter
Amylase, Day 7 -2.3  (9.68)
Amylase, Day 14 -2.8  (10.48)
Lipase, Day 7 -4.0  (8.93)
Lipase, Day 14 -5.3  (12.69)
51.Secondary Outcome
Title Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase
Hide Description Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Units per Liter
Amylase, Day 3, n= 16 Number Analyzed 16 participants
3.3  (8.93)
Amylase, Day 7, n= 15 Number Analyzed 15 participants
-1.9  (6.77)
Amylase, Day 9, n= 15 Number Analyzed 15 participants
1.1  (6.32)
Lipase, Day 3, n= 16 Number Analyzed 16 participants
7.7  (21.62)
Lipase, Day 7, n= 15 Number Analyzed 15 participants
0.0  (8.20)
Lipase, Day 9, n= 15 Number Analyzed 15 participants
3.5  (3.89)
52.Secondary Outcome
Title Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase
Hide Description Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Day -1 for Period 1.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Units per Liter
Amylase, Baseline 56.4  (14.66)
Amylase, Day 7 54.1  (13.15)
Amylase, Day 14 53.6  (14.48)
Lipase, Baseline 22.2  (14.00)
Lipase, Day 7 18.2  (9.72)
Lipase, Day 14 16.9  (14.65)
53.Secondary Outcome
Title Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase
Hide Description Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Units per Liter
Amylase, Baseline, n= 16 Number Analyzed 16 participants
53.6  (14.48)
Amylase, Day 3, n= 16 Number Analyzed 16 participants
56.8  (19.32)
Amylase, Day 7, n= 15 Number Analyzed 15 participants
52.7  (12.97)
Amylase, Day 9, n= 15 Number Analyzed 15 participants
55.7  (13.39)
Lipase, Baseline, n= 16 Number Analyzed 16 participants
16.9  (14.65)
Lipase, Day 3, n= 16 Number Analyzed 16 participants
24.6  (34.82)
Lipase, Day 7, n= 15 Number Analyzed 15 participants
17.5  (10.69)
Lipase, Day 9, n= 15 Number Analyzed 15 participants
21.0  (14.16)
54.Secondary Outcome
Title Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Hide Description Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter
Creatinine, Day 7 5.69  (3.508)
Creatinine, Day 14 7.36  (4.833)
Total bilirubin, Day 7 2.25  (4.756)
Total bilirubin, Day 14 2.10  (5.109)
Direct bilirubin, Day 7 0.15  (0.634)
Direct bilirubin, Day 14 0.64  (0.699)
55.Secondary Outcome
Title Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Hide Description Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter
Creatinine, Day 3, n= 16 Number Analyzed 16 participants
-2.34  (3.755)
Creatinine, Day 7, n= 15 Number Analyzed 15 participants
3.53  (3.802)
Creatinine, Day 9, n= 15 Number Analyzed 15 participants
0.28  (3.569)
Total bilirubin, Day 3, n= 16 Number Analyzed 16 participants
-0.82  (3.475)
Total bilirubin, Day 7, n= 15 Number Analyzed 15 participants
-0.26  (2.466)
Total bilirubin, Day 9, n= 15 Number Analyzed 15 participants
-1.91  (2.252)
Direct bilirubin, Day 3, n= 16 Number Analyzed 16 participants
-0.26  (0.534)
Direct bilirubin, Day 7, n= 15 Number Analyzed 15 participants
-0.03  (0.547)
Direct bilirubin, Day 9, n= 15 Number Analyzed 15 participants
-0.49  (0.501)
56.Secondary Outcome
Title Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Hide Description Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Day -1 for Period 1.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter
Creatinine, Baseline 80.16  (10.103)
Creatinine, Day 7 85.85  (9.586)
Creatinine, Day 14 87.52  (10.058)
Total bilirubin, Baseline 9.64  (6.143)
Total bilirubin, Day 7 11.89  (6.781)
Total bilirubin, Day 14 11.74  (7.046)
Direct bilirubin, Baseline 1.76  (1.016)
Direct bilirubin, Day 7 1.91  (0.752)
Direct bilirubin, Day 14 2.40  (1.035)
57.Secondary Outcome
Title Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Hide Description Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, creatinine and uric acid. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter
Creatinine, Baseline, n= 16 Number Analyzed 16 participants
87.52  (10.058)
Creatinine, Day 3, n= 16 Number Analyzed 16 participants
85.18  (10.314)
Creatinine, Day 7, n= 15 Number Analyzed 15 participants
91.53  (9.504)
Creatinine, Day 9, n= 15 Number Analyzed 15 participants
88.27  (9.916)
Total bilirubin, Baseline, n= 16 Number Analyzed 16 participants
11.44  (6.022)
Total bilirubin, Day 3, n= 16 Number Analyzed 16 participants
10.62  (7.886)
Total bilirubin, Day 7, n= 15 Number Analyzed 15 participants
11.33  (5.487)
Total bilirubin, Day 9, n= 15 Number Analyzed 15 participants
9.68  (4.603)
Direct bilirubin, Baseline, n= 16 Number Analyzed 16 participants
2.40  (1.035)
Direct bilirubin, Day 3, n= 16 Number Analyzed 16 participants
2.14  (1.065)
Direct bilirubin, Day 7, n= 15 Number Analyzed 15 participants
2.41  (0.828)
Direct bilirubin, Day 9, n= 15 Number Analyzed 15 participants
1.95  (0.673)
58.Secondary Outcome
Title Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Hide Description Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of of total protein, albumin and globulin. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Grams per Liter
Total Protein, Day 7 2.6  (3.20)
Total Protein, Day 14 2.9  (2.66)
Globulin, Day 7 2.5  (1.37)
Globulin, Day 14 2.8  (1.91)
Albumin, Day 7 0.1  (2.22)
Albumin, Day 14 0.1  (2.05)
59.Secondary Outcome
Title Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Hide Description Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total protein, albumin and globulin. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Grams per Liter
Total Protein, Day 3, n= 16 Number Analyzed 16 participants
0.1  (2.68)
Total Protein, Day 7, n= 15 Number Analyzed 15 participants
3.1  (2.85)
Total Protein, Day 9, n= 15 Number Analyzed 15 participants
0.8  (3.28)
Globulin, Day 3, n= 16 Number Analyzed 16 participants
0.2  (1.17)
Globulin, Day 7, n= 15 Number Analyzed 15 participants
2.3  (0.96)
Globulin, Day 9, n= 15 Number Analyzed 15 participants
0.2  (1.08)
Albumin, Day 3, n= 16 Number Analyzed 16 participants
-0.1  (1.95)
Albumin, Day 7, n= 15 Number Analyzed 15 participants
0.9  (2.20)
Albumin, Day 9, n= 15 Number Analyzed 15 participants
0.6  (2.50)
60.Secondary Outcome
Title Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Hide Description Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total protein, albumin and globulin. Baseline was defined as Day -1 for Period 1.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Grams per Liter
Total Protein, Baseline 69.8  (3.64)
Total Protein, Day 7 72.4  (3.70)
Total Protein, Day 14 72.6  (3.10)
Globulin, Baseline 25.9  (2.50)
Globulin, Day 7 28.4  (2.60)
Globulin, Day 14 28.7  (1.99)
Albumin, Baseline 43.9  (2.36)
Albumin, Day 7 44.0  (1.90)
Albumin, Day 14 43.9  (2.41)
61.Secondary Outcome
Title Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Hide Description Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, creatinine and uric acid. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Grams per Liter
Total Protein, Baseline, n= 16 Number Analyzed 16 participants
72.6  (3.10)
Total Protein, Day 3, n= 16 Number Analyzed 16 participants
72.8  (2.96)
Total Protein, Day 7, n= 15 Number Analyzed 15 participants
75.7  (2.89)
Total Protein, Day 9, n= 15 Number Analyzed 15 participants
73.3  (2.61)
Globulin, Baseline, n= 16 Number Analyzed 16 participants
28.7  (1.99)
Globulin, Day 3, n= 16 Number Analyzed 16 participants
28.9  (2.31)
Globulin, Day 7, n= 15 Number Analyzed 15 participants
30.9  (1.96)
Globulin, Day 9, n= 15 Number Analyzed 15 participants
28.8  (1.90)
Albumin, Baseline, n= 16 Number Analyzed 16 participants
43.9  (2.41)
Albumin, Day 3, n= 16 Number Analyzed 16 participants
43.9  (1.89)
Albumin, Day 7, n= 15 Number Analyzed 15 participants
44.8  (2.08)
Albumin, Day 9, n= 15 Number Analyzed 15 participants
44.5  (1.73)
62.Secondary Outcome
Title Period 1: Change From Baseline in Specific Gravity of Urine
Hide Description Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Ratio
Day 7 0.0007  (0.01085)
Day 14 0.0011  (0.00941)
63.Secondary Outcome
Title Period 2: Change From Baseline in Specific Gravity of Urine
Hide Description Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Ratio
Day 3, n= 16 Number Analyzed 16 participants
0.0031  (0.00666)
Day 7, n= 15 Number Analyzed 15 participants
0.0024  (0.00608)
Day 9, n= 15 Number Analyzed 15 participants
0.0005  (0.00872)
64.Secondary Outcome
Title Period 1: Absolute Values of Specific Gravity of Urine
Hide Description Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Day -1 for Period 1.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Ratio
Baseline 1.0136  (0.01095)
Day 7 1.0143  (0.00556)
Day 14 1.0147  (0.00789)
65.Secondary Outcome
Title Period 2: Absolute Values of Specific Gravity of Urine
Hide Description Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Ratio
Baseline, n= 16 Number Analyzed 16 participants
1.0147  (0.00789)
Day 3, n= 16 Number Analyzed 16 participants
1.0178  (0.00584)
Day 7, n= 15 Number Analyzed 15 participants
1.0170  (0.00655)
Day 9, n= 15 Number Analyzed 15 participants
1.0151  (0.00788)
66.Secondary Outcome
Title Period 1: Change From Baseline in Potential of Hydrogen (pH) of Urine
Hide Description Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: pH
Day 7 -0.34  (0.397)
Day 14 -0.19  (0.544)
67.Secondary Outcome
Title Period 2: Change From Baseline in pH of Urine
Hide Description Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: pH
Day 3, n= 16 Number Analyzed 16 participants
0.19  (0.479)
Day 7, n= 15 Number Analyzed 15 participants
0.10  (0.471)
Day 9, n= 15 Number Analyzed 15 participants
0.10  (0.507)
68.Secondary Outcome
Title Period 1: Absolute Values of pH of Urine
Hide Description Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Day -1 for Period 1.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: pH
Baseline 6.22  (0.446)
Day 7 5.88  (0.289)
Day 14 6.03  (0.531)
69.Secondary Outcome
Title Period 2: Absolute Values of pH of Urine
Hide Description Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: pH
Baseline, n= 16 Number Analyzed 16 participants
6.03  (0.531)
Day 3, n= 16 Number Analyzed 16 participants
6.22  (0.482)
Day 7, n= 15 Number Analyzed 15 participants
6.07  (0.320)
Day 9, n= 15 Number Analyzed 15 participants
6.07  (0.320)
70.Secondary Outcome
Title Period 1: Change From Baseline in Urine Urobilinogen
Hide Description Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter
Day 7 -2.5395  (5.45976)
Day 14 -2.5395  (5.45976)
71.Secondary Outcome
Title Period 2: Change From Baseline in Urine Urobilinogen
Hide Description Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter
Day 3, n= 16 Number Analyzed 16 participants
0.0000  (0.00000)
Day 7, n= 15 Number Analyzed 15 participants
0.0000  (0.00000)
Day 9, n= 15 Number Analyzed 15 participants
0.0000  (0.00000)
72.Secondary Outcome
Title Period 1: Absolute Values of Urine Urobilinogen
Hide Description Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1.
Time Frame Baseline and at Days 7, 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter
Baseline 5.9255  (5.45976)
Day 7 3.3860  (0.0000)
Day 14 3.3860  (0.0000)
73.Secondary Outcome
Title Period 2: Absolute Values of Urine Urobilinogen
Hide Description Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame Baseline and at Days 3, 7, 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter
Baseline, n= 16 Number Analyzed 16 participants
3.3860  (0.0000)
Day 3, n= 16 Number Analyzed 16 participants
3.3860  (0.0000)
Day 7, n= 15 Number Analyzed 15 participants
3.3860  (0.0000)
Day 9, n= 15 Number Analyzed 15 participants
3.3860  (0.0000)
74.Secondary Outcome
Title Period 1: Change From Baseline in Heart Rate
Hide Description Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Day 1, 2 and 4 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Day 1, 2 hours post-dose 1.5  (6.87)
Day 1, 4 hours post-dose -3.3  (10.37)
75.Secondary Outcome
Title Period 2: Change From Baseline in Heart Rate
Hide Description Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Day 1, 2 hours post-dose, n= 16 Number Analyzed 16 participants
5.0  (4.37)
Day 1, 4 hours post-dose, n= 16 Number Analyzed 16 participants
2.8  (6.62)
Day 4, Pre-dose, n= 15 Number Analyzed 15 participants
-0.5  (11.10)
Day 4, 2 hours post-dose, n= 15 Number Analyzed 15 participants
3.3  (5.86)
Day 4, 4 hours post-dose, n= 15 Number Analyzed 15 participants
-0.3  (5.13)
Day 7, Pre-dose, n= 15 Number Analyzed 15 participants
0.3  (11.18)
Day 7, 2 hours post-dose, n= 15 Number Analyzed 15 participants
1.8  (6.72)
Day 7, 4 hours post-dose, n= 15 Number Analyzed 15 participants
-2.3  (7.08)
Day 9 post-dose, n= 15 Number Analyzed 15 participants
2.1  (7.84)
76.Secondary Outcome
Title Period 1: Absolute Values of Heart Rate
Hide Description Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Day 1, 2 and 4 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Baseline 67.6  (8.72)
Day 1, 2 hours post-dose 69.1  (11.04)
Day 1, 4 hours post-dose 64.4  (11.87)
77.Secondary Outcome
Title Period 2: Absolute Values of Heart Rate
Hide Description Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period.
Time Frame Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Baseline, n= 16 Number Analyzed 16 participants
66.5  (8.06)
Day 1, 2 hours post-dose, n= 16 Number Analyzed 16 participants
71.5  (9.95)
Day 1, 4 hours post-dose, n= 16 Number Analyzed 16 participants
69.3  (11.38)
Day 4, Pre-dose, n= 15 Number Analyzed 15 participants
65.1  (10.48)
Day 4, 2 hours post-dose, n= 15 Number Analyzed 15 participants
68.9  (8.00)
Day 4, 4 hours post-dose, n= 15 Number Analyzed 15 participants
65.3  (8.97)
Day 7, Pre-dose, n= 15 Number Analyzed 15 participants
65.9  (10.25)
Day 7, 2 hours post-dose, n= 15 Number Analyzed 15 participants
67.4  (6.39)
Day 7, 4 hours post-dose, n= 15 Number Analyzed 15 participants
63.3  (8.31)
Day 9 post-dose, n= 15 Number Analyzed 15 participants
67.7  (9.23)
78.Secondary Outcome
Title 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
Hide Description Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interal, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Day 1, 2 and 4 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Milliseconds
PR Interval, Day 1, 2 hours post-dose 1.5  (9.67)
PR Interval, Day 1, 4 hours post-dose -1.9  (8.64)
QRS Duration, Day 1, 2 hours post-dose -1.1  (3.68)
QRS Duration, Day 1, 4 hours post-dose 0.3  (4.96)
QT Interval, Day 1, 2 hours post-dose -7.5  (14.12)
QT Interval, Day 1, 4 hours post-dose 5.8  (23.18)
QTcF Interval, Day 1, 2 hours post-dose -4.9  (10.63)
QTcF Interval, Day 1, 4 hours post-dose -1.3  (10.56)
QTcB Interval, Day 1, 2 hours post-dose -4.1  (12.70)
QTcB Interval, Day 1, 4 hours post-dose -5.4  (12.39)
79.Secondary Outcome
Title Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
Hide Description Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interal, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Milliseconds
PR Interval, Day 1, 2 hours post-dose, n= 16 Number Analyzed 16 participants
-6.8  (6.77)
PR Interval, Day 1, 4 hours post-dose, n= 16 Number Analyzed 16 participants
-3.7  (5.99)
PR Interval, Day 4, Pre-dose, n= 15 Number Analyzed 15 participants
-0.5  (4.56)
PR Interval, Day 4, 2 hours post-dose, n= 15 Number Analyzed 15 participants
-6.9  (6.67)
PR Interval, Day 4, 4 hours post-dose, n= 15 Number Analyzed 15 participants
-3.9  (7.83)
PR Interval, Day 7, Pre-dose, n= 15 Number Analyzed 15 participants
-2.7  (8.57)
PR Interval, Day 7, 2 hours post-dose, n= 15 Number Analyzed 15 participants
-3.3  (7.06)
PR Interval, Day 7, 4 hours post-dose, n= 15 Number Analyzed 15 participants
-3.7  (8.53)
PR Interval, Day 9 post-dose, n= 15 Number Analyzed 15 participants
1.2  (6.42)
QRS Duration, Day 1, 2 hours post-dose, n= 16 Number Analyzed 16 participants
-2.5  (4.40)
QRS Duration, Day 1, 4 hours post-dose, n= 16 Number Analyzed 16 participants
-1.4  (4.69)
QRS Duration, Day 4, Pre-dose, n= 15 Number Analyzed 15 participants
0.5  (3.44)
QRS Duration, Day 4, 2 hours post-dose, n= 15 Number Analyzed 15 participants
0.5  (5.72)
QRS Duration, Day 4, 4 hours post-dose, n= 15 Number Analyzed 15 participants
-0.2  (2.70)
QRS Duration, Day 7, Pre-dose, n= 15 Number Analyzed 15 participants
3.3  (4.53)
QRS Duration, Day 7, 2 hours post-dose, n= 15 Number Analyzed 15 participants
1.5  (5.15)
QRS Duration, Day 7, 4 hours post-dose, n= 15 Number Analyzed 15 participants
0.3  (3.72)
QRS Duration, Day 9 post-dose, n= 15 Number Analyzed 15 participants
3.0  (5.36)
QT Interval, Day 1, 2 hours post-dose, n= 16 Number Analyzed 16 participants
-12.6  (9.11)
QT Interval, Day 1, 4 hours post-dose, n= 16 Number Analyzed 16 participants
-1.8  (14.72)
QT Interval, Day 4, Pre-dose, n= 15 Number Analyzed 15 participants
7.3  (18.27)
QT Interval, Day 4, 2 hours post-dose, n= 15 Number Analyzed 15 participants
-6.8  (15.72)
QT Interval, Day 4, 4 hours post-dose, n= 15 Number Analyzed 15 participants
5.6  (14.64)
QT Interval, Day 7, Pre-dose, n= 15 Number Analyzed 15 participants
3.5  (18.31)
QT Interval, Day 7, 2 hours post-dose, n= 15 Number Analyzed 15 participants
-8.4  (16.15)
QT Interval, Day 7, 4 hours post-dose, n= 15 Number Analyzed 15 participants
5.8  (17.37)
QT Interval, Day 9 post-dose, n= 15 Number Analyzed 15 participants
4.1  (16.46)
QTcF Interval, Day 1, 2 hours post-dose, n= 16 Number Analyzed 16 participants
-4.4  (7.29)
QTcF Interval, Day 1, 4 hours post-dose, n= 16 Number Analyzed 16 participants
2.4  (7.77)
QTcF Interval, Day 4, Pre-dose, n= 15 Number Analyzed 15 participants
6.1  (11.17)
QTcF Interval, Day 4, 2 hours post-dose, n= 15 Number Analyzed 15 participants
-0.6  (10.91)
QTcF Interval, Day 4, 4 hours post-dose, n= 15 Number Analyzed 15 participants
4.5  (8.22)
QTcF Interval, Day 7, Pre-dose, n= 15 Number Analyzed 15 participants
4.1  (8.71)
QTcF Interval, Day 7, 2 hours post-dose, n= 15 Number Analyzed 15 participants
-5.1  (9.34)
QTcF Interval, Day 7, 4 hours post-dose, n= 15 Number Analyzed 15 participants
0.6  (9.03)
QTcF Interval, Day 9 post-dose, n= 15 Number Analyzed 15 participants
7.9  (8.53)
QTcB Interval, Day 1, 2 hours post-dose, n= 16 Number Analyzed 16 participants
0.7  (8.83)
QTcB Interval, Day 1, 4 hours post-dose, n= 16 Number Analyzed 16 participants
4.7  (8.49)
QTcB Interval, Day 4, Pre-dose, n= 15 Number Analyzed 15 participants
5.5  (18.50)
QTcB Interval, Day 4, 2 hours post-dose, n= 15 Number Analyzed 15 participants
2.5  (12.37)
QTcB Interval, Day 4, 4 hours post-dose, n= 15 Number Analyzed 15 participants
4.3  (8.52)
QTcB Interval, Day 7, Pre-dose, n= 15 Number Analyzed 15 participants
4.6  (16.31)
QTcB Interval, Day 7, 2 hours post-dose, n= 15 Number Analyzed 15 participants
-3.2  (11.64)
QTcB Interval, Day 7, 4 hours post-dose, n= 15 Number Analyzed 15 participants
-1.7  (12.06)
QTcB Interval, Day 9 post-dose, n= 15 Number Analyzed 15 participants
10.3  (12.19)
80.Secondary Outcome
Title Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
Hide Description Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period.
Time Frame Baseline and at Day 1, 2 and 4 hours post-dose
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Safety Population
Arm/Group Title TAF/FTC
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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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Milliseconds
PR Interval, Baseline 161.3  (16.53)
PR Interval, Day 1, 2 hours post-dose 162.8  (19.01)
PR Interval, Day 1, 4 hours post-dose 159.4  (19.47)
QRS Duration, Baseline 91.0  (8.22)
QRS Duration, Day 1, 2 hours post-dose 89.9  (7.54)
QRS Duration, Day 1, 4 hours post-dose 91.3  (8.14)
QT Interval, Baseline 377.8  (24.84)
QT Interval, Day 1, 2 hours post-dose 370.3  (24.74)
QT Interval, Day 1, 4 hours post-dose 383.6  (32.12)
QTcF Interval, Baseline 391.6  (12.92)
QTcF Interval, Day 1, 2 hours post-dose 386.7  (14.33)
QTcF Interval, Day 1, 4 hours post-dose 390.3  (18.27)
QTcB Interval, Baseline 398.8  (11.28)
QTcB Interval, Day 1, 2 hours post-dose 394.6  (15.14)
QTcB Interval, Day 1, 4 hours post-dose 393.3  (18.26)
81.Secondary Outcome
Title Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
Hide Description Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period.
Time Frame Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Milliseconds
PR Interval, Baseline, n= 16 Number Analyzed 16 participants
167.3  (19.46)
PR Interval, Day 1, 2 hours post-dose, n= 16 Number Analyzed 16 participants
160.4  (19.73)
PR Interval, Day 1, 4 hours post-dose, n= 16 Number Analyzed 16 participants
163.6  (19.04)
PR Interval, Day 4, Pre-dose, n= 15 Number Analyzed 15 participants
167.1  (22.20)
PR Interval, Day 4, 2 hours post-dose, n= 15 Number Analyzed 15 participants
160.7  (19.59)
PR Interval, Day 4, 4 hours post-dose, n= 15 Number Analyzed 15 participants
163.7  (19.29)
PR Interval, Day 7, Pre-dose, n= 15 Number Analyzed 15 participants
164.9  (21.11)
PR Interval, Day 7, 2 hours post-dose, n= 15 Number Analyzed 15 participants
164.3  (20.95)
PR Interval, Day 7, 4 hours post-dose, n= 15 Number Analyzed 15 participants
163.9  (22.05)
PR Interval, Day 9 post-dose, n= 15 Number Analyzed 15 participants
168.8  (23.70)
QRS Duration, Baseline, n= 16 Number Analyzed 16 participants
91.4  (7.87)
QRS Duration, Day 1, 2 hours post-dose, n= 16 Number Analyzed 16 participants
88.9  (8.20)
QRS Duration, Day 1, 4 hours post-dose, n= 16 Number Analyzed 16 participants
90.1  (7.66)
QRS Duration, Day 4, Pre-dose, n= 15 Number Analyzed 15 participants
91.8  (8.37)
QRS Duration, Day 4, 2 hours post-dose, n= 15 Number Analyzed 15 participants
91.8  (9.12)
QRS Duration, Day 4, 4 hours post-dose, n= 15 Number Analyzed 15 participants
91.1  (8.51)
QRS Duration, Day 7, Pre-dose, n= 15 Number Analyzed 15 participants
94.5  (8.25)
QRS Duration, Day 7, 2 hours post-dose, n= 15 Number Analyzed 15 participants
92.7  (7.49)
QRS Duration, Day 7, 4 hours post-dose, n= 15 Number Analyzed 15 participants
91.6  (7.23)
QRS Duration, Day 9 post-dose, n= 15 Number Analyzed 15 participants
94.3  (8.17)
QT Interval, Baseline, n= 16 Number Analyzed 16 participants
377.7  (22.66)
QT Interval, Day 1, 2 hours post-dose, n= 16 Number Analyzed 16 participants
365.1  (23.71)
QT Interval, Day 1, 4 hours post-dose, n= 16 Number Analyzed 16 participants
375.9  (30.14)
QT Interval, Day 4, Pre-dose, n= 15 Number Analyzed 15 participants
385.6  (26.65)
QT Interval, Day 4, 2 hours post-dose, n= 15 Number Analyzed 15 participants
371.5  (27.31)
QT Interval, Day 4, 4 hours post-dose, n= 15 Number Analyzed 15 participants
383.9  (31.05)
QT Interval, Day 7, Pre-dose, n= 15 Number Analyzed 15 participants
381.7  (22.25)
QT Interval, Day 7, 2 hours post-dose, n= 15 Number Analyzed 15 participants
369.9  (25.66)
QT Interval, Day 7, 4 hours post-dose, n= 15 Number Analyzed 15 participants
384.1  (30.53)
QT Interval, Day 9 post-dose, n= 15 Number Analyzed 15 participants
382.4  (26.55)
QTcF Interval, Baseline, n= 16 Number Analyzed 16 participants
390.0  (13.48)
QTcF Interval, Day 1, 2 hours, n= 16 Number Analyzed 16 participants
385.6  (15.44)
QTcF Interval, Day 1, 4 hours post-dose, n= 16 Number Analyzed 16 participants
392.4  (15.95)
QTcF Interval, Day 4, Pre-dose, n= 15 Number Analyzed 15 participants
395.0  (21.88)
QTcF Interval, Day 4, 2 hours post-dose, n= 15 Number Analyzed 15 participants
388.3  (17.56)
QTcF Interval, Day 4, 4 hours post-dose, n= 15 Number Analyzed 15 participants
393.4  (18.97)
QTcF Interval, Day 7, Pre-dose, n= 15 Number Analyzed 15 participants
393.0  (18.42)
QTcF Interval, Day 7, 2 hours post-dose, n= 15 Number Analyzed 15 participants
383.8  (16.19)
QTcF Interval, Day 7, 4 hours post-dose, n= 15 Number Analyzed 15 participants
389.5  (18.06)
QTcF Interval, Day 9 post-dose, n= 15 Number Analyzed 15 participants
396.8  (18.51)
QTcB Interval, Baseline, n= 16 Number Analyzed 16 participants
395.7  (14.19)
QTcB Interval, Day 1, 2 hours post-dose, n= 16 Number Analyzed 16 participants
396.4  (17.29)
QTcB Interval, Day 1, 4 hours post-dose, n= 16 Number Analyzed 16 participants
400.4  (16.20)
QTcB Interval, Day 4, Pre-dose, n= 15 Number Analyzed 15 participants
399.2  (25.96)
QTcB Interval, Day 4, 2 hours post-dose, n= 15 Number Analyzed 15 participants
396.2  (16.01)
QTcB Interval, Day 4, 4 hours post-dose, n= 15 Number Analyzed 15 participants
398.0  (17.53)
QTcB Interval, Day 7, Pre-dose, n= 15 Number Analyzed 15 participants
398.3  (23.83)
QTcB Interval, Day 7, 2 hours post-dose, n= 15 Number Analyzed 15 participants
390.5  (13.31)
QTcB Interval, Day 7, 4 hours post-dose, n= 15 Number Analyzed 15 participants
391.9  (16.35)
QTcB Interval, Day 9 post-dose, n= 15 Number Analyzed 15 participants
404.0  (20.62)
82.Secondary Outcome
Title Period 1: Change From Baseline in Temperature
Hide Description Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 2, 3, 4, 5 and 7
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Safety Population
Arm/Group Title TAF/FTC
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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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Degree Celsius
Day 2 -0.16  (0.400)
Day 3 -0.15  (0.576)
Day 4 -0.09  (0.406)
Day 5 -0.15  (0.371)
Day 7 -0.24  (0.491)
83.Secondary Outcome
Title Period 2: Change From Baseline in Temperature
Hide Description Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 4, 7, 9, and 10
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Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points
Arm/Group Title TAF/FTC+GSK3640254
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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.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: Degree Celsius
Day 4 -0.10  (0.344)
Day 7 -0.07  (0.337)
Day 9 -0.01  (0.386)
Day 10 0.07  (0.320)
84.Secondary Outcome
Title Period 1: Absolute Values of Temperature
Hide Description Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.
Time Frame Baseline and at Days 2, 3, 4, 5 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Degree Celsius
Baseline 36.49  (0.298)
Day 2 36.33  (0.342)
Day 3 36.34  (0.456)
Day 4 36.41  (0.431)
Day 5 36.34  (0.360)
Day 7 36.25  (0.407)
85.Secondary Outcome
Title Period 2: Absolute Values of Temperature
Hide Description Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.
Time Frame Baseline and at Days 4, 7, 9, and 10
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Degree Celsius
Baseline, n= 16 Number Analyzed 16 participants
36.49  (0.257)
Day 4, n=15 Number Analyzed 15 participants
36.37  (0.348)
Day 7, n=15 Number Analyzed 15 participants
36.40  (0.421)
Day 9, n=15 Number Analyzed 15 participants
36.46  (0.378)
Day 10, n=15 Number Analyzed 15 participants
36.53  (0.282)
86.Secondary Outcome
Title Period 1: Change From Baseline in Pulse Rate
Hide Description Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 2, 3, 4, 5 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Day 2 -1.2  (9.77)
Day 3 -3.8  (9.94)
Day 4 -4.0  (9.67)
Day 5 -1.6  (10.47)
Day 7 -7.6  (7.83)
87.Secondary Outcome
Title Period 2: Change From Baseline in Pulse Rate
Hide Description Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline and at Days 4, 7, 9, and 10
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points
Arm/Group Title TAF/FTC+GSK3640254
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Day 4 2.4  (18.62)
Day 7 1.9  (15.62)
Day 9 -0.3  (10.20)
Day 10 9.5  (11.12)
88.Secondary Outcome
Title Period 1: Absolute Values of Pulse Rate
Hide Description Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.
Time Frame Baseline and at Days 2, 3, 4, 5 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title TAF/FTC
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Baseline 73.9  (9.24)
Day 2 72.8  (10.14)
Day 3 70.1  (11.18)
Day 4 69.9  (10.81)
Day 5 72.3  (12.38)
Day 7 66.3  (10.20)
89.Secondary Outcome