Trial Outcomes & Findings for Study to Evaluate the Pharmacokinetic (PK) Interactions Between GSK3640254 and Dolutegravir (DTG) (NCT NCT03816696)

NCT ID: NCT03816696

Last Updated: 2020-03-19

Results Overview

Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Pharmacokinetic Parameter Population consisted of all participants who underwent plasma pharmacokinetic sampling and had evaluable pharmacokinetic parameters estimated.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

16 participants

Primary outcome timeframe

Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Results posted on

2020-03-19

Participant Flow

This was an open-label, fixed-sequence, two-way drug interaction and 3-period study. Participants received treatment A- dolutegravir 50 milligram (mg) in Period 1; treatment B- GSK3640254 200 mg in Period 2 and treatment C- dolutegravir 50 mg and GSK3640254 200 mg in Period 3.

A total of 30 participants were screened, of which 14 were screening failures. Hence, 16 participants were enrolled in this study. This study was conducted at a single center in the United States.

Participant milestones

Participant milestones
Measure
Dolutegravir/GSK3640254/Dolutegravir+GSK3640254
Participants received treatment A- dolutegravir 50 mg, tablets, orally, once daily on Days 1 to 5 in Period 1; followed by washout period of 4 days between last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2; followed by treatment B- GSK3640254 200 mg, capsules, orally, once daily on Days 1 to 7 in Period 2; further followed by treatment C- dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally, once daily on Days 1 to 7 in Period 3.
Period 1 (Up to Day 5)
STARTED
16
Period 1 (Up to Day 5)
COMPLETED
16
Period 1 (Up to Day 5)
NOT COMPLETED
0
Wash Out Period (Days 6 to 9)
STARTED
16
Wash Out Period (Days 6 to 9)
COMPLETED
16
Wash Out Period (Days 6 to 9)
NOT COMPLETED
0
Period 2 (Up to Day 7)
STARTED
16
Period 2 (Up to Day 7)
COMPLETED
16
Period 2 (Up to Day 7)
NOT COMPLETED
0
Period 3 (Up to Day 11)
STARTED
16
Period 3 (Up to Day 11)
COMPLETED
16
Period 3 (Up to Day 11)
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate the Pharmacokinetic (PK) Interactions Between GSK3640254 and Dolutegravir (DTG)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Dolutegravir/GSK3640254/Dolutegravir+GSK3640254
n=16 Participants
Participants received treatment A- dolutegravir 50 mg, tablets, orally, once daily on Days 1 to 5 in Period 1; followed by washout period of 4 days between last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2; followed by treatment B- GSK3640254 200 mg, capsules, orally, once daily on Days 1 to 7 in Period 2; further followed by treatment C- dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally, once daily on Days 1 to 7 in Period 3.
Age, Continuous
36.7 Years
STANDARD_DEVIATION 10.66 • n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
Sex: Female, Male
Male
15 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian - East Asian Heritage
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian - South East Asian Heritage
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Black or African American
3 Participants
n=5 Participants
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
11 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Population: Pharmacokinetic Parameter Population.

Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Pharmacokinetic Parameter Population consisted of all participants who underwent plasma pharmacokinetic sampling and had evaluable pharmacokinetic parameters estimated.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing (AUC[0 to Tau]) of Dolutegravir for Dolutegravir Arm
64627.8 Hours* nanogram per milliliter
Geometric Coefficient of Variation 20.1

PRIMARY outcome

Timeframe: Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Population: Pharmacokinetic Parameter Population.

Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: AUC(0 to Tau) of Dolutegravir for Dolutegravir + GSK3640254 Arm
75860.5 Hours* nanogram per milliliter
Geometric Coefficient of Variation 22.7

PRIMARY outcome

Timeframe: Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Population: Pharmacokinetic Parameter Population.

Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Maximum Observed Concentration (Cmax) of Dolutegravir for Dolutegravir Arm
4962 Nanogram per milliliter
Geometric Coefficient of Variation 16.5

PRIMARY outcome

Timeframe: Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Population: Pharmacokinetic Parameter Population.

Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Cmax of Dolutegravir for Dolutegravir + GSK3640254 Arm
5408 Nanogram per milliliter
Geometric Coefficient of Variation 17.2

PRIMARY outcome

Timeframe: Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Population: Pharmacokinetic Parameter Population.

Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of Dolutegravir for Dolutegravir Arm
1373 Nanogram per milliliter
Geometric Coefficient of Variation 30.6

PRIMARY outcome

Timeframe: Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Population: Pharmacokinetic Parameter Population.

Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Ctau of Dolutegravir for Dolutegravir + GSK3640254 Arm
1696 Nanogram per milliliter
Geometric Coefficient of Variation 31.1

PRIMARY outcome

Timeframe: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Population: Pharmacokinetic Parameter Population.

Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: AUC(0 to Tau) of GSK3640254 for GSK3640254 Arm
26.72 Hours* microgram per milliliter
Geometric Coefficient of Variation 32.3

PRIMARY outcome

Timeframe: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Population: Pharmacokinetic Parameter Population.

Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: AUC(0 to Tau) of GSK3640254 for Dolutegravir + GSK3640254 Arm
27.84 Hours* microgram per milliliter
Geometric Coefficient of Variation 30.1

PRIMARY outcome

Timeframe: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Population: Pharmacokinetic Parameter Population.

Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Cmax of GSK3640254 for GSK3640254 Arm
1.676 Microgram per milliliter
Geometric Coefficient of Variation 26.4

PRIMARY outcome

Timeframe: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Population: Pharmacokinetic Parameter Population.

Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Cmax of GSK3640254 for Dolutegravir + GSK3640254 Arm
1.662 Microgram per milliliter
Geometric Coefficient of Variation 26.8

PRIMARY outcome

Timeframe: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Population: Pharmacokinetic Parameter Population.

Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Ctau of GSK3640254 for GSK3640254 Arm
0.8583 Microgram per milliliter
Geometric Coefficient of Variation 38.3

PRIMARY outcome

Timeframe: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Population: Pharmacokinetic Parameter Population.

Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Ctau of GSK3640254 for Dolutegravir + GSK3640254 Arm
0.8549 Microgram per milliliter
Geometric Coefficient of Variation 34.1

SECONDARY outcome

Timeframe: Up to Day 27

Population: Safety Population.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; and other important medical events which may require medical or surgical intervention. Safety Population consisted of all participants who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
n=16 Participants
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
n=16 Participants
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
Non-SAEs
1 Participants
3 Participants
2 Participants
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
SAEs
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Baseline (Day -1) and at Day 9

Population: Safety Population.

Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Basophils
-0.003 10^9 cells per liter
Standard Deviation 0.0124
Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Eosinophils
0.046 10^9 cells per liter
Standard Deviation 0.1198
Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Lymphocytes
0.013 10^9 cells per liter
Standard Deviation 0.3793
Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Monocytes
-0.020 10^9 cells per liter
Standard Deviation 0.0829
Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Neutrophils
-0.217 10^9 cells per liter
Standard Deviation 0.6421
Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Platelet count
-6.5 10^9 cells per liter
Standard Deviation 21.73

SECONDARY outcome

Timeframe: Baseline (Period 1 Day 9) and at Day 7

Population: Safety Population.

Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Lymphocytes
-0.154 10^9 cells per liter
Standard Deviation 0.2718
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Monocytes
-0.024 10^9 cells per liter
Standard Deviation 0.0701
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Neutrophils
-0.160 10^9 cells per liter
Standard Deviation 0.3762
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Platelet count
-6.0 10^9 cells per liter
Standard Deviation 30.58
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Basophils
-0.006 10^9 cells per liter
Standard Deviation 0.0089
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Eosinophils
-0.026 10^9 cells per liter
Standard Deviation 0.0810

SECONDARY outcome

Timeframe: Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).

Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 7: Basophils, n=16
0.007 10^9 cells per liter
Standard Deviation 0.0135
Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 4: Eosinophils, n=16
-0.001 10^9 cells per liter
Standard Deviation 0.0448
Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 10: Lymphocytes, n=16
-0.117 10^9 cells per liter
Standard Deviation 0.2628
Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 4: Monocytes, n=16
0.049 10^9 cells per liter
Standard Deviation 0.1627
Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 10: Monocytes, n=16
-0.018 10^9 cells per liter
Standard Deviation 0.0693
Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 7: Neutrophils, n=16
0.076 10^9 cells per liter
Standard Deviation 0.5969
Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 10: Neutrophils, n=16
0.204 10^9 cells per liter
Standard Deviation 0.5116
Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 4: Basophils, n=16
0.003 10^9 cells per liter
Standard Deviation 0.0101
Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 10: Basophils, n=16
0.003 10^9 cells per liter
Standard Deviation 0.0144
Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 7: Eosinophils, n=16
0.004 10^9 cells per liter
Standard Deviation 0.0846
Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 10: Eosinophils, n=16
-0.036 10^9 cells per liter
Standard Deviation 0.0468
Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 4: Lymphocytes, n=16
-0.130 10^9 cells per liter
Standard Deviation 0.2931
Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 7: Lymphocytes, n=16
-0.033 10^9 cells per liter
Standard Deviation 0.3260
Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 7: Monocytes, n=16
0.003 10^9 cells per liter
Standard Deviation 0.0850
Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 4: Neutrophils, n=16
0.443 10^9 cells per liter
Standard Deviation 1.5098
Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 4: Platelet count, n=16
-4.9 10^9 cells per liter
Standard Deviation 11.08
Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 7: Platelet count, n=15
-11.5 10^9 cells per liter
Standard Deviation 12.03
Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 10: Platelet count, n=16
-5.9 10^9 cells per liter
Standard Deviation 16.50

SECONDARY outcome

Timeframe: Baseline (Day -1) and at Day 9

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Change From Baseline in Hematology Parameter: Hemoglobin
4.4 Grams per liter
Standard Deviation 5.97

SECONDARY outcome

Timeframe: Baseline (Period 1 Day 9) and at Day 7

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Change From Baseline in Hematology Parameter: Hemoglobin
0.1 Grams per liter
Standard Deviation 2.53

SECONDARY outcome

Timeframe: Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Change From Baseline in Hematology Parameter: Hemoglobin
Day 4
3.3 Grams per liter
Standard Deviation 3.00
Period 3: Change From Baseline in Hematology Parameter: Hemoglobin
Day 7
0.6 Grams per liter
Standard Deviation 3.50
Period 3: Change From Baseline in Hematology Parameter: Hemoglobin
Day 10
1.2 Grams per liter
Standard Deviation 3.69

SECONDARY outcome

Timeframe: Baseline (Day -1) and at Day 9

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Change From Baseline in Hematology Parameter: Hematocrit
0.0178 Proportion of red blood cells in blood
Standard Deviation 0.01988

SECONDARY outcome

Timeframe: Baseline (Period 1 Day 9) and at Day 7

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Change From Baseline in Hematology Parameter: Hematocrit
-0.0013 Proportion of red blood cells in blood
Standard Deviation 0.00948

SECONDARY outcome

Timeframe: Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Change From Baseline in Hematology Parameter: Hematocrit
Day 4
0.0035 Proportion of red blood cells in blood
Standard Deviation 0.00794
Period 3: Change From Baseline in Hematology Parameter: Hematocrit
Day 10
-0.0041 Proportion of red blood cells in blood
Standard Deviation 0.01402
Period 3: Change From Baseline in Hematology Parameter: Hematocrit
Day 7
-0.0049 Proportion of red blood cells in blood
Standard Deviation 0.01101

SECONDARY outcome

Timeframe: Baseline (Day -1) and at Day 9

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Change From Baseline in Hematology Parameter: Erythrocytes
0.170 Trillion cells per liter
Standard Deviation 0.2080

SECONDARY outcome

Timeframe: Baseline (Period 1 Day 9) and at Day 7

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Change From Baseline in Hematology Parameter: Erythrocytes
0.036 Trillion cells per liter
Standard Deviation 0.1020

SECONDARY outcome

Timeframe: Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Change From Baseline in Hematology Parameter: Erythrocytes
Day 7
-0.079 Trillion cells per liter
Standard Deviation 0.1038
Period 3: Change From Baseline in Hematology Parameter: Erythrocytes
Day 10
-0.054 Trillion cells per liter
Standard Deviation 0.1540
Period 3: Change From Baseline in Hematology Parameter: Erythrocytes
Day 4
0.016 Trillion cells per liter
Standard Deviation 0.0943

SECONDARY outcome

Timeframe: Baseline (Day -1) and at Day 9

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
0.63 Femtoliter
Standard Deviation 0.774

SECONDARY outcome

Timeframe: Baseline (Period 1 Day 9) and at Day 7

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
-0.86 Femtoliter
Standard Deviation 0.564

SECONDARY outcome

Timeframe: Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 7
0.36 Femtoliter
Standard Deviation 0.762
Period 3: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 10
0.05 Femtoliter
Standard Deviation 0.954
Period 3: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 4
0.40 Femtoliter
Standard Deviation 0.542

SECONDARY outcome

Timeframe: Baseline (Day -1) and at Day 9

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
-0.11 Picograms
Standard Deviation 0.279

SECONDARY outcome

Timeframe: Baseline (Period 1 Day 9) and at Day 7

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
-0.17 Picograms
Standard Deviation 0.218

SECONDARY outcome

Timeframe: Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Day 4
0.55 Picograms
Standard Deviation 0.225
Period 3: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Day 7
0.55 Picograms
Standard Deviation 0.329
Period 3: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Day 10
0.52 Picograms
Standard Deviation 0.315

SECONDARY outcome

Timeframe: Baseline (Day -1) and at Day 9

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Glucose
0.063 Millimoles per liter
Standard Deviation 0.4235
Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Anion gap
-1.2 Millimoles per liter
Standard Deviation 1.33
Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Calcium
0.025 Millimoles per liter
Standard Deviation 0.0599
Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Potassium
0.05 Millimoles per liter
Standard Deviation 0.356
Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Sodium
0.3 Millimoles per liter
Standard Deviation 2.15
Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood urea nitrogen
0.297 Millimoles per liter
Standard Deviation 0.9823
Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Cholesterol
0.088 Millimoles per liter
Standard Deviation 0.6858
Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Triglycerides
-0.084 Millimoles per liter
Standard Deviation 0.3983
Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Carbon dioxide
-0.1 Millimoles per liter
Standard Deviation 2.03
Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Chloride
1.6 Millimoles per liter
Standard Deviation 2.63
Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Phosphate
0.091 Millimoles per liter
Standard Deviation 0.1531

SECONDARY outcome

Timeframe: Baseline (Period 1 Day 9) and at Day 7

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Glucose
-0.249 Millimoles per liter
Standard Deviation 0.1748
Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Cholesterol
-0.269 Millimoles per liter
Standard Deviation 0.2363
Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Triglycerides
0.087 Millimoles per liter
Standard Deviation 0.2374
Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Anion gap
2.2 Millimoles per liter
Standard Deviation 1.52
Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Calcium
0.014 Millimoles per liter
Standard Deviation 0.0245
Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Carbon dioxide
-1.3 Millimoles per liter
Standard Deviation 1.53
Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Chloride
-0.7 Millimoles per liter
Standard Deviation 1.78
Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Phosphate
0.037 Millimoles per liter
Standard Deviation 0.0955
Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Potassium
-0.03 Millimoles per liter
Standard Deviation 0.272
Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Sodium
0.3 Millimoles per liter
Standard Deviation 1.74
Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood urea nitrogen
-0.341 Millimoles per liter
Standard Deviation 0.3937

SECONDARY outcome

Timeframe: Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 10: Glucose
-0.066 Millimoles per liter
Standard Deviation 0.2205
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 4: Triglycerides
0.034 Millimoles per liter
Standard Deviation 0.2316
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 7: Triglycerides
-0.094 Millimoles per liter
Standard Deviation 0.2578
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 7: Anion gap
0.1 Millimoles per liter
Standard Deviation 1.69
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 7: Chloride
-0.3 Millimoles per liter
Standard Deviation 1.39
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 4: Glucose
0.062 Millimoles per liter
Standard Deviation 0.1638
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 7: Glucose
0.103 Millimoles per liter
Standard Deviation 0.1806
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 4: Cholesterol
0.096 Millimoles per liter
Standard Deviation 0.2400
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 7: Cholesterol
-0.008 Millimoles per liter
Standard Deviation 0.2693
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 10: Cholesterol
-0.030 Millimoles per liter
Standard Deviation 0.2366
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 10: Triglycerides
0.095 Millimoles per liter
Standard Deviation 0.2178
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 4: Anion gap
-4.1 Millimoles per liter
Standard Deviation 1.24
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 10: Anion gap
0.8 Millimoles per liter
Standard Deviation 1.65
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 4: Calcium
-0.003 Millimoles per liter
Standard Deviation 0.0416
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 7: Calcium
0.026 Millimoles per liter
Standard Deviation 0.0413
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 10: Calcium:
0.035 Millimoles per liter
Standard Deviation 0.0561
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 4: Carbon dioxide
0.9 Millimoles per liter
Standard Deviation 1.65
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 7: Carbon dioxide
0.1 Millimoles per liter
Standard Deviation 1.59
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 10: Carbon dioxide
1.0 Millimoles per liter
Standard Deviation 2.16
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 4: Chloride
0.7 Millimoles per liter
Standard Deviation 1.92
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 10: Chloride
-1.1 Millimoles per liter
Standard Deviation 1.86
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 4: Phosphate
-0.004 Millimoles per liter
Standard Deviation 0.0808
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 7: Phosphate
-0.013 Millimoles per liter
Standard Deviation 0.1151
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 10: Phosphate
-0.051 Millimoles per liter
Standard Deviation 0.1115
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 4: Potassium
-0.04 Millimoles per liter
Standard Deviation 0.239
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 7: Potassium
-0.03 Millimoles per liter
Standard Deviation 0.218
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 10: Potassium
0.06 Millimoles per liter
Standard Deviation 0.189
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 4: Sodium
-2.0 Millimoles per liter
Standard Deviation 1.37
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 7: Sodium
-0.1 Millimoles per liter
Standard Deviation 1.65
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 10: Sodium
0.5 Millimoles per liter
Standard Deviation 1.90
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 4: Blood urea nitrogen
0.054 Millimoles per liter
Standard Deviation 0.5287
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 7: Blood urea nitrogen
-0.178 Millimoles per liter
Standard Deviation 0.3542
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 10: Blood urea nitrogen
-0.026 Millimoles per liter
Standard Deviation 0.5156

SECONDARY outcome

Timeframe: Baseline (Day -1) and at Day 9

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase
Creatine kinase
-32.0 International units per liter
Standard Deviation 61.33
Period 1: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase
Lactate dehydrogenase
-21.9 International units per liter
Standard Deviation 14.16
Period 1: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase
ALT
-0.3 International units per liter
Standard Deviation 8.28
Period 1: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase
ALP
-0.1 International units per liter
Standard Deviation 7.67
Period 1: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase
AST
-0.7 International units per liter
Standard Deviation 3.36
Period 1: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase
Gamma-glutamyl transferase
-2.1 International units per liter
Standard Deviation 3.13

SECONDARY outcome

Timeframe: Baseline (Period 1 Day 9) and at Day 7

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Creatine kinase
22.6 International units per liter
Standard Deviation 58.21
Period 2: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Lactate dehydrogenase
9.1 International units per liter
Standard Deviation 5.76
Period 2: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
ALT
-0.6 International units per liter
Standard Deviation 2.80
Period 2: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
ALP
1.9 International units per liter
Standard Deviation 2.70
Period 2: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
AST
0.2 International units per liter
Standard Deviation 1.87
Period 2: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Gamma-glutamyl transferase
-0.8 International units per liter
Standard Deviation 1.28

SECONDARY outcome

Timeframe: Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 10: Gamma-glutamyl transferase
0.5 International units per liter
Standard Deviation 1.51
Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 4: Creatine kinase
-32.1 International units per liter
Standard Deviation 131.30
Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 7: Creatine kinase
-37.1 International units per liter
Standard Deviation 158.35
Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 10: Creatine kinase
-42.1 International units per liter
Standard Deviation 162.94
Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 4: Lactate dehydrogenase
5.9 International units per liter
Standard Deviation 7.38
Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 7: Lactate dehydrogenase
-0.9 International units per liter
Standard Deviation 7.02
Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 10: Lactate dehydrogenase
0.1 International units per liter
Standard Deviation 10.32
Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 4: ALT
1.1 International units per liter
Standard Deviation 4.36
Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 7: ALT
0.7 International units per liter
Standard Deviation 4.69
Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 10: ALT
1.9 International units per liter
Standard Deviation 4.11
Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 4: ALP
-1.6 International units per liter
Standard Deviation 2.00
Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 7: ALP
-0.6 International units per liter
Standard Deviation 2.39
Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 10: ALP
0.8 International units per liter
Standard Deviation 4.06
Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 4: AST
0.9 International units per liter
Standard Deviation 2.45
Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 7: AST
-0.5 International units per liter
Standard Deviation 2.68
Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 10: AST
0.3 International units per liter
Standard Deviation 2.29
Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 4: Gamma-glutamyl transferase
-0.8 International units per liter
Standard Deviation 0.75
Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 7: Gamma-glutamyl transferase
-0.3 International units per liter
Standard Deviation 1.06

SECONDARY outcome

Timeframe: Baseline (Day -1) and at Day 9

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Creatinine
5.41 Micromoles per liter
Standard Deviation 7.253
Period 1: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Bilirubin
0.01 Micromoles per liter
Standard Deviation 4.516
Period 1: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Urate
-32.3 Micromoles per liter
Standard Deviation 42.01
Period 1: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Direct bilirubin
0.03 Micromoles per liter
Standard Deviation 0.677

SECONDARY outcome

Timeframe: Baseline (Period 1 Day 9) and at Day 7

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Urate
-7.1 Micromoles per liter
Standard Deviation 14.52
Period 2: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Creatinine
-3.36 Micromoles per liter
Standard Deviation 4.219
Period 2: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Bilirubin
0.27 Micromoles per liter
Standard Deviation 1.299
Period 2: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Direct bilirubin
0.06 Micromoles per liter
Standard Deviation 0.328

SECONDARY outcome

Timeframe: Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Day 7: Direct bilirubin
-0.19 Micromoles per liter
Standard Deviation 0.436
Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Day 4: Urate
0.0 Micromoles per liter
Standard Deviation 16.23
Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Day 7: Urate
-15.6 Micromoles per liter
Standard Deviation 26.39
Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Day 10: Urate
-1.4 Micromoles per liter
Standard Deviation 24.69
Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Day 4: Creatinine
7.90 Micromoles per liter
Standard Deviation 4.239
Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Day 7: Creatinine
9.89 Micromoles per liter
Standard Deviation 4.014
Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Day 10: Creatinine
1.99 Micromoles per liter
Standard Deviation 4.739
Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Day 4: Bilirubin
2.24 Micromoles per liter
Standard Deviation 2.659
Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Day 7: Bilirubin
-0.21 Micromoles per liter
Standard Deviation 1.455
Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Day 10: Bilirubin
1.43 Micromoles per liter
Standard Deviation 2.011
Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Day 4: Direct bilirubin
0.33 Micromoles per liter
Standard Deviation 0.425
Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Day 10: Direct bilirubin
0.22 Micromoles per liter
Standard Deviation 0.248

SECONDARY outcome

Timeframe: Baseline (Day -1) and at Day 9

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
Albumin
0.4 Grams per liter
Standard Deviation 2.45
Period 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
Globulin
0.8 Grams per liter
Standard Deviation 1.11
Period 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
Protein
1.2 Grams per liter
Standard Deviation 3.06

SECONDARY outcome

Timeframe: Baseline (Period 1 Day 9) and at Day 7

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
Albumin
0.9 Grams per liter
Standard Deviation 1.45
Period 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
Globulin
-1.1 Grams per liter
Standard Deviation 0.77
Period 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
Protein
-0.2 Grams per liter
Standard Deviation 1.76

SECONDARY outcome

Timeframe: Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
Day 10: Albumin
0.4 Grams per liter
Standard Deviation 2.06
Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
Day 4: Globulin
-0.9 Grams per liter
Standard Deviation 1.29
Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
Day 4: Albumin
0.9 Grams per liter
Standard Deviation 1.00
Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
Day 7: Albumin
0.2 Grams per liter
Standard Deviation 1.22
Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
Day 7: Globulin
1.0 Grams per liter
Standard Deviation 1.10
Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
Day 10: Globulin
0.5 Grams per liter
Standard Deviation 1.32
Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
Day 4: Protein
0.0 Grams per liter
Standard Deviation 1.75
Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
Day 7: Protein
1.2 Grams per liter
Standard Deviation 1.80
Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
Day 10: Protein
0.9 Grams per liter
Standard Deviation 2.90

SECONDARY outcome

Timeframe: Baseline (Day -1) and at Day 9

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Amylase
3.1 Units per liter
Standard Deviation 9.63
Period 1: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Lipase
-3.4 Units per liter
Standard Deviation 8.97

SECONDARY outcome

Timeframe: Baseline (Period 1 Day 9) and at Day 7

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Amylase
-2.8 Units per liter
Standard Deviation 4.65
Period 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Lipase
-0.7 Units per liter
Standard Deviation 3.79

SECONDARY outcome

Timeframe: Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Day 4: Amylase
-1.6 Units per liter
Standard Deviation 3.18
Period 3: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Day 7: Amylase
0.1 Units per liter
Standard Deviation 4.25
Period 3: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Day 10: Amylase
-0.9 Units per liter
Standard Deviation 6.08
Period 3: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Day 4: Lipase
4.7 Units per liter
Standard Deviation 6.10
Period 3: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Day 7: Lipase
-0.8 Units per liter
Standard Deviation 4.76
Period 3: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Day 10: Lipase
0.1 Units per liter
Standard Deviation 5.24

SECONDARY outcome

Timeframe: Baseline (Day -1) and at Day 9

Population: Safety Population.

Urine samples were collected to analyze the urinalysis parameter: 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. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Change From Baseline in Urinalysis Parameter: Specific Gravity
0.0053 Ratio
Standard Deviation 0.00865

SECONDARY outcome

Timeframe: Baseline (Period 1 Day 9) and at Day 7

Population: Safety Population.

Urine samples were collected to analyze the urinalysis parameter: 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. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Change From Baseline in Urinalysis Parameter: Specific Gravity
-0.0004 Ratio
Standard Deviation 0.00645

SECONDARY outcome

Timeframe: Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Population: Safety Population.

Urine samples were collected to analyze the urinalysis parameter: 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. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Change From Baseline in Urinalysis Parameter: Specific Gravity
Day 4
0.0003 Ratio
Standard Deviation 0.00652
Period 3: Change From Baseline in Urinalysis Parameter: Specific Gravity
Day 7
-0.0007 Ratio
Standard Deviation 0.00545
Period 3: Change From Baseline in Urinalysis Parameter: Specific Gravity
Day 10
-0.0016 Ratio
Standard Deviation 0.00901

SECONDARY outcome

Timeframe: Baseline (Day -1) and at Day 9

Population: Safety Population.

Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Change From Baseline in Urinalysis Parameter: Urobilinogen
0.0000 Micromoles per liter
Standard Deviation 0.00000

SECONDARY outcome

Timeframe: Baseline (Period 1 Day 9) and at Day 7

Population: Safety Population.

Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Change From Baseline in Urinalysis Parameter: Urobilinogen
0.0000 Micromoles per liter
Standard Deviation 0.00000

SECONDARY outcome

Timeframe: Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Population: Safety Population.

Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Change From Baseline in Urinalysis Parameter: Urobilinogen
Day 4
0.0000 Micromoles per liter
Standard Deviation 0.00000
Period 3: Change From Baseline in Urinalysis Parameter: Urobilinogen
Day 7
0.0000 Micromoles per liter
Standard Deviation 0.00000
Period 3: Change From Baseline in Urinalysis Parameter: Urobilinogen
Day 10
0.0000 Micromoles per liter
Standard Deviation 0.00000

SECONDARY outcome

Timeframe: Baseline (Day -1) and at Day 9

Population: Safety Population.

Urine samples were collected to analyze the urinalysis parameter: 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 the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH)
-0.22 pH
Standard Deviation 0.730

SECONDARY outcome

Timeframe: Baseline (Period 1 Day 9) and at Day 7

Population: Safety Population.

Urine samples were collected to analyze the urinalysis parameter: 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 the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Change From Baseline in Urinalysis Parameter: pH
0.13 pH
Standard Deviation 0.428

SECONDARY outcome

Timeframe: Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Population: Safety Population.

Urine samples were collected to analyze the urinalysis parameter: 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 the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Change From Baseline in Urinalysis Parameter: pH
Day 4
0.03 pH
Standard Deviation 0.531
Period 3: Change From Baseline in Urinalysis Parameter: pH
Day 7
-0.13 pH
Standard Deviation 0.500
Period 3: Change From Baseline in Urinalysis Parameter: pH
Day 10
0.16 pH
Standard Deviation 0.569

SECONDARY outcome

Timeframe: Day 9

Population: Safety Population.

Urine samples were collected at indicated time points to analyze parameters including glucose, protein, occult blood, ketones, nitrite, bilirubin and leukocyte esterase levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace, 1+ (low concentrations present) and 2+ (moderate concentrations present) indicating proportional concentrations in the urine sample.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Number of Participants With Urinalysis Dipstick Results
Ketones: Negative
15 Participants
Period 1: Number of Participants With Urinalysis Dipstick Results
Bilirubin: Negative
16 Participants
Period 1: Number of Participants With Urinalysis Dipstick Results
Glucose: Negative
16 Participants
Period 1: Number of Participants With Urinalysis Dipstick Results
Ketones: Trace
1 Participants
Period 1: Number of Participants With Urinalysis Dipstick Results
Leukocyte Esterase: Negative
16 Participants
Period 1: Number of Participants With Urinalysis Dipstick Results
Nitrite: Negative
16 Participants
Period 1: Number of Participants With Urinalysis Dipstick Results
Occult Blood: Negative
15 Participants
Period 1: Number of Participants With Urinalysis Dipstick Results
Occult Blood: 2+
1 Participants
Period 1: Number of Participants With Urinalysis Dipstick Results
Protein: Negative
16 Participants

SECONDARY outcome

Timeframe: Day 7

Population: Safety Population.

Urine samples were collected at indicated time points to analyze parameters including glucose, protein, occult blood, ketones, nitrite, bilirubin and leukocyte esterase levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace, 1+ (low concentrations present), and 2+ (moderate concentrations present) indicating proportional concentrations in the urine sample.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Number of Participants With Urinalysis Dipstick Results
Bilirubin: Negative
16 Participants
Period 2: Number of Participants With Urinalysis Dipstick Results
Glucose: Negative
16 Participants
Period 2: Number of Participants With Urinalysis Dipstick Results
Ketones: Negative
15 Participants
Period 2: Number of Participants With Urinalysis Dipstick Results
Ketones: 1+
1 Participants
Period 2: Number of Participants With Urinalysis Dipstick Results
Leukocyte Esterase: Negative
15 Participants
Period 2: Number of Participants With Urinalysis Dipstick Results
Leukocyte Esterase: 1+
1 Participants
Period 2: Number of Participants With Urinalysis Dipstick Results
Nitrite: Negative
16 Participants
Period 2: Number of Participants With Urinalysis Dipstick Results
Occult Blood: Negative
16 Participants
Period 2: Number of Participants With Urinalysis Dipstick Results
Protein: Negative
16 Participants

SECONDARY outcome

Timeframe: Days 4, 7 and 10

Population: Safety Population.

Urine samples were collected at indicated time points to analyze parameters including glucose, protein, occult blood, ketones, nitrite, bilirubin and leukocyte esterase levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace, 1+ (low concentrations present), and 2+ (moderate concentrations present)indicating proportional concentrations in the urine sample.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Number of Participants With Urinalysis Dipstick Results
Ketones: Day 10, Negative
16 Participants
Period 3: Number of Participants With Urinalysis Dipstick Results
Protein: Day 4, Negative
16 Participants
Period 3: Number of Participants With Urinalysis Dipstick Results
Protein: Day 7, Negative
16 Participants
Period 3: Number of Participants With Urinalysis Dipstick Results
Bilirubin: Day 4, Negative
16 Participants
Period 3: Number of Participants With Urinalysis Dipstick Results
Bilirubin: Day 7, Negative
16 Participants
Period 3: Number of Participants With Urinalysis Dipstick Results
Bilirubin: Day 10, Negative
16 Participants
Period 3: Number of Participants With Urinalysis Dipstick Results
Glucose: Day 4, Negative
16 Participants
Period 3: Number of Participants With Urinalysis Dipstick Results
Glucose: Day 7, Negative
16 Participants
Period 3: Number of Participants With Urinalysis Dipstick Results
Glucose: Day 10, Negative
16 Participants
Period 3: Number of Participants With Urinalysis Dipstick Results
Ketones: Day 4, Negative
16 Participants
Period 3: Number of Participants With Urinalysis Dipstick Results
Ketones: Day 7, Negative
16 Participants
Period 3: Number of Participants With Urinalysis Dipstick Results
Leukocyte Esterase: Day 4, Negative
16 Participants
Period 3: Number of Participants With Urinalysis Dipstick Results
Leukocyte Esterase: Day 7, Negative
16 Participants
Period 3: Number of Participants With Urinalysis Dipstick Results
Leukocyte Esterase: Day 10, Negative
16 Participants
Period 3: Number of Participants With Urinalysis Dipstick Results
Nitrite: Day 4, Negative
16 Participants
Period 3: Number of Participants With Urinalysis Dipstick Results
Nitrite: Day 7, Negative
16 Participants
Period 3: Number of Participants With Urinalysis Dipstick Results
Nitrite: Day 10, Negative
16 Participants
Period 3: Number of Participants With Urinalysis Dipstick Results
Occult Blood: Day 4, Negative
16 Participants
Period 3: Number of Participants With Urinalysis Dipstick Results
Occult Blood: Day 7, Negative
16 Participants
Period 3: Number of Participants With Urinalysis Dipstick Results
Occult Blood: Day 10, Negative
16 Participants
Period 3: Number of Participants With Urinalysis Dipstick Results
Protein: Day 10, Negative
16 Participants

SECONDARY outcome

Timeframe: Baseline, Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours

Population: Safety Population.

Twelve-lead electrocardiograms (ECG) were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments on Day 1 of Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
PR Interval: Day 5, 2 hours
1.3 Milliseconds
Standard Deviation 8.52
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
PR Interval: Day 5, 4 hours
1.9 Milliseconds
Standard Deviation 12.94
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
QRS Duration: Day 5, 2 hours
0.8 Milliseconds
Standard Deviation 3.99
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
QRS Duration: Day 5, 4 hours
0.6 Milliseconds
Standard Deviation 2.78
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
QT Interval: Day 1, 2 hours
-5.5 Milliseconds
Standard Deviation 8.21
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
QT Interval: Day 1, 4 hours
9.9 Milliseconds
Standard Deviation 12.91
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
QT Interval: Day 5, 2 hours
-16.3 Milliseconds
Standard Deviation 16.64
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
QT Interval: Day 5, 4 hours
1.2 Milliseconds
Standard Deviation 16.07
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
QTcF Interval: Day 5, Pre-dose
-7.1 Milliseconds
Standard Deviation 8.53
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
QTcB Interval: Day 1, 2 hours
-4.5 Milliseconds
Standard Deviation 10.26
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
QTcB Interval: Day 1, 4 hours
-7.4 Milliseconds
Standard Deviation 9.16
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
QTcB Interval: Day 5, Pre-dose
-6.7 Milliseconds
Standard Deviation 8.16
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
QTcB Interval: Day 5, 2 hours
-3.4 Milliseconds
Standard Deviation 10.84
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
PR Interval: Day 1, 2 hours
-0.5 Milliseconds
Standard Deviation 9.33
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
PR Interval: Day 1, 4 hours
1.7 Milliseconds
Standard Deviation 8.34
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
PR Interval: Day 5, Pre-dose
4.7 Milliseconds
Standard Deviation 6.32
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
QRS Duration: Day 1, 2 hours
1.8 Milliseconds
Standard Deviation 3.04
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
QRS Duration: Day 1, 4 hours
1.3 Milliseconds
Standard Deviation 3.32
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
QRS Duration: Day 5, Pre-dose
-0.8 Milliseconds
Standard Deviation 3.21
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
QT Interval: Day 5, Pre-dose
-6.8 Milliseconds
Standard Deviation 11.74
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
QTcF Interval: Day 1, 2 hours
-5.0 Milliseconds
Standard Deviation 8.42
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
QTcF Interval: Day 1, 4 hours
-1.6 Milliseconds
Standard Deviation 8.52
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
QTcF Interval: Day 5, 2 hours
-7.9 Milliseconds
Standard Deviation 9.92
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
QTcF Interval: Day 5, 4 hours
-3.9 Milliseconds
Standard Deviation 7.56
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
QTcB Interval: Day 5, 4 hours
-5.9 Milliseconds
Standard Deviation 11.62

SECONDARY outcome

Timeframe: Baseline; Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours

Population: Safety Population.

Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments on Day 1 of Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 5, 2 hours
3.7 Milliseconds
Standard Deviation 9.36
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 5, 4 hours
10.2 Milliseconds
Standard Deviation 10.44
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 1, 2 hours
2.4 Milliseconds
Standard Deviation 13.45
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 1, 4 hours
2.6 Milliseconds
Standard Deviation 12.62
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 5, Pre-dose
8.4 Milliseconds
Standard Deviation 5.92
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 5, 2 hours
9.9 Milliseconds
Standard Deviation 11.93
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 5, 4 hours
0.6 Milliseconds
Standard Deviation 2.70
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 1, 2 hours
-7.9 Milliseconds
Standard Deviation 11.47
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 5, Pre-dose
2.8 Milliseconds
Standard Deviation 17.38
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 5, 2 hours
-7.1 Milliseconds
Standard Deviation 16.13
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 1, 4 hours
3.1 Milliseconds
Standard Deviation 6.44
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 5, Pre-dose
6.6 Milliseconds
Standard Deviation 6.79
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 1, 2 hours
-3.3 Milliseconds
Standard Deviation 6.31
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 1, 4 hours
-3.0 Milliseconds
Standard Deviation 5.55
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 5, Pre-dose
-2.1 Milliseconds
Standard Deviation 6.15
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 5, 2 hours
-3.4 Milliseconds
Standard Deviation 7.81
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 5, 4 hours
-6.4 Milliseconds
Standard Deviation 6.77
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 1, 2 hours
0.1 Milliseconds
Standard Deviation 2.54
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 1, 4 hours
-1.1 Milliseconds
Standard Deviation 4.08
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 5, Pre-dose
0.3 Milliseconds
Standard Deviation 3.89
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 5, 2 hours
-0.2 Milliseconds
Standard Deviation 3.85
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 1, 4 hours
4.6 Milliseconds
Standard Deviation 13.48
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 5, 4 hours
6.3 Milliseconds
Standard Deviation 20.51
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 1, 2 hours
-1.3 Milliseconds
Standard Deviation 8.74
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 5, 4 hours
12.4 Milliseconds
Standard Deviation 8.57

SECONDARY outcome

Timeframe: Baseline; Day 1: 2 hours, 4 hours; Days 4, 5 and 7: Pre-dose, 2 hours and 4 hours; Day 10

Population: Safety Population.

Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 1, 4 hours
-2.1 Milliseconds
Standard Deviation 3.80
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 1, 4 hours
-1.9 Milliseconds
Standard Deviation 8.19
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 5, 4 hours
-2.7 Milliseconds
Standard Deviation 7.77
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 1, 2 hours
-7.8 Milliseconds
Standard Deviation 8.68
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 5, 2 hours
1.1 Milliseconds
Standard Deviation 9.42
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 7, 4 hours
3.6 Milliseconds
Standard Deviation 7.28
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 10
1.6 Milliseconds
Standard Deviation 7.36
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 1, 2 hours
3.8 Milliseconds
Standard Deviation 9.50
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 1, 4 hours
7.4 Milliseconds
Standard Deviation 10.78
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 4, Pre-dose
3.8 Milliseconds
Standard Deviation 13.72
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 4, 2 hours
-0.6 Milliseconds
Standard Deviation 17.78
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 4, 4 hours
8.6 Milliseconds
Standard Deviation 12.83
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 5, Pre-dose
10.6 Milliseconds
Standard Deviation 13.25
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 5, 2 hours
5.5 Milliseconds
Standard Deviation 12.47
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 5, 4 hours
11.3 Milliseconds
Standard Deviation 9.50
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 7, Pre-dose
2.1 Milliseconds
Standard Deviation 14.09
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 7, 2 hours
4.4 Milliseconds
Standard Deviation 14.43
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 7, 4 hours
1.4 Milliseconds
Standard Deviation 10.35
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 10
0.2 Milliseconds
Standard Deviation 10.89
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 1, 2 hours
1.9 Milliseconds
Standard Deviation 7.47
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 4, Pre-dose
-0.4 Milliseconds
Standard Deviation 6.97
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 4, 2 hours
0.9 Milliseconds
Standard Deviation 8.48
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 4, 4 hours
-2.9 Milliseconds
Standard Deviation 9.53
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 5, Pre-dose
-1.4 Milliseconds
Standard Deviation 10.59
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 5, 2 hours
-3.2 Milliseconds
Standard Deviation 9.13
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 7, Pre-dose
3.6 Milliseconds
Standard Deviation 7.61
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 7, 2 hours
-1.0 Milliseconds
Standard Deviation 9.47
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 7, 4 hours
-0.4 Milliseconds
Standard Deviation 7.61
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 10
2.3 Milliseconds
Standard Deviation 8.60
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 1, 2 hours
1.1 Milliseconds
Standard Deviation 5.47
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 4, Pre-dose
2.0 Milliseconds
Standard Deviation 5.61
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 4, 2 hours
-1.3 Milliseconds
Standard Deviation 3.09
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 4, 4 hours
0.5 Milliseconds
Standard Deviation 6.63
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 5, Pre-dose
1.8 Milliseconds
Standard Deviation 6.18
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 5, 2 hours
1.3 Milliseconds
Standard Deviation 5.11
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 5, 4 hours
-0.5 Milliseconds
Standard Deviation 3.31
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 7, Pre-dose
0.6 Milliseconds
Standard Deviation 3.58
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 7, 2 hours
0.3 Milliseconds
Standard Deviation 4.93
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 7, 4 hours
-0.4 Milliseconds
Standard Deviation 3.72
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 10
1.7 Milliseconds
Standard Deviation 5.45
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 1, 4 hours
4.4 Milliseconds
Standard Deviation 13.15
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 4, Pre-dose
1.4 Milliseconds
Standard Deviation 14.28
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 4, 2 hours
-11.2 Milliseconds
Standard Deviation 14.53
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 4, 4 hours
7.4 Milliseconds
Standard Deviation 13.68
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 5, Pre-dose
-1.4 Milliseconds
Standard Deviation 13.57
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 5, 2 hours
-6.9 Milliseconds
Standard Deviation 10.65
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 5, 4 hours
3.9 Milliseconds
Standard Deviation 14.59
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 7, Pre-dose
3.2 Milliseconds
Standard Deviation 17.34
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 7, 2 hours
-5.6 Milliseconds
Standard Deviation 14.01
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 7, 4 hours
8.0 Milliseconds
Standard Deviation 15.38
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 10
5.1 Milliseconds
Standard Deviation 10.39
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 1, 2 hours
-0.4 Milliseconds
Standard Deviation 5.63
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 1, 4 hours
6.6 Milliseconds
Standard Deviation 4.97
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 4, Pre-dose
2.7 Milliseconds
Standard Deviation 8.21
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 4, 2 hours
-2.5 Milliseconds
Standard Deviation 8.41
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 4, 4 hours
8.1 Milliseconds
Standard Deviation 9.10
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 5, Pre-dose
6.1 Milliseconds
Standard Deviation 8.14
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 5, 4 hours
8.6 Milliseconds
Standard Deviation 6.26
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 7, Pre-dose
2.0 Milliseconds
Standard Deviation 9.21
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 7, 2 hours
0.6 Milliseconds
Standard Deviation 7.46

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5

Population: Safety Population.

SBP and DBP were measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Day 2
3.5 Millimeters of mercury
Standard Deviation 9.97
Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Day 3
-0.4 Millimeters of mercury
Standard Deviation 8.88
Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Day 4
3.7 Millimeters of mercury
Standard Deviation 11.97
Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Day 5
-6.2 Millimeters of mercury
Standard Deviation 8.88
Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Day 2
4.3 Millimeters of mercury
Standard Deviation 6.70
Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Day 3
0.9 Millimeters of mercury
Standard Deviation 9.89
Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Day 4
2.3 Millimeters of mercury
Standard Deviation 8.50
Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Day 5
-2.6 Millimeters of mercury
Standard Deviation 10.70

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7

Population: Safety Population.

SBP and DBP were measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Change From Baseline in SBP and DBP
SBP: Day 6
-0.1 Millimeters of mercury
Standard Deviation 8.01
Period 2: Change From Baseline in SBP and DBP
SBP: Day 7
0.6 Millimeters of mercury
Standard Deviation 4.57
Period 2: Change From Baseline in SBP and DBP
DBP: Day 2
-0.4 Millimeters of mercury
Standard Deviation 7.03
Period 2: Change From Baseline in SBP and DBP
DBP: Day 3
1.1 Millimeters of mercury
Standard Deviation 4.46
Period 2: Change From Baseline in SBP and DBP
DBP: Day 4
-0.4 Millimeters of mercury
Standard Deviation 4.67
Period 2: Change From Baseline in SBP and DBP
DBP: Day 5
-1.3 Millimeters of mercury
Standard Deviation 4.85
Period 2: Change From Baseline in SBP and DBP
DBP: Day 6
0.3 Millimeters of mercury
Standard Deviation 6.37
Period 2: Change From Baseline in SBP and DBP
SBP: Day 2
1.7 Millimeters of mercury
Standard Deviation 5.19
Period 2: Change From Baseline in SBP and DBP
SBP: Day 3
1.3 Millimeters of mercury
Standard Deviation 6.83
Period 2: Change From Baseline in SBP and DBP
SBP: Day 4
3.0 Millimeters of mercury
Standard Deviation 7.73
Period 2: Change From Baseline in SBP and DBP
SBP: Day 5
-0.5 Millimeters of mercury
Standard Deviation 5.40
Period 2: Change From Baseline in SBP and DBP
DBP: Day 7
0.4 Millimeters of mercury
Standard Deviation 5.62

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11

Population: Safety Population.

SBP and DBP were measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Change From Baseline in SBP and DBP
DBP: Day 4
1.2 Millimeters of mercury
Standard Deviation 4.51
Period 3: Change From Baseline in SBP and DBP
SBP: Day 2
-0.1 Millimeters of mercury
Standard Deviation 7.66
Period 3: Change From Baseline in SBP and DBP
SBP: Day 3
-3.4 Millimeters of mercury
Standard Deviation 6.54
Period 3: Change From Baseline in SBP and DBP
SBP: Day 4
-3.3 Millimeters of mercury
Standard Deviation 6.63
Period 3: Change From Baseline in SBP and DBP
SBP: Day 5
3.6 Millimeters of mercury
Standard Deviation 17.17
Period 3: Change From Baseline in SBP and DBP
SBP: Day 6
-1.4 Millimeters of mercury
Standard Deviation 7.08
Period 3: Change From Baseline in SBP and DBP
SBP: Day 7
-2.1 Millimeters of mercury
Standard Deviation 7.76
Period 3: Change From Baseline in SBP and DBP
SBP: Day 8
-2.0 Millimeters of mercury
Standard Deviation 9.36
Period 3: Change From Baseline in SBP and DBP
SBP: Day 9
-2.3 Millimeters of mercury
Standard Deviation 8.00
Period 3: Change From Baseline in SBP and DBP
SBP: Day 10
-4.3 Millimeters of mercury
Standard Deviation 8.35
Period 3: Change From Baseline in SBP and DBP
SBP: Day 11
-3.4 Millimeters of mercury
Standard Deviation 7.69
Period 3: Change From Baseline in SBP and DBP
DBP: Day 2
1.3 Millimeters of mercury
Standard Deviation 3.32
Period 3: Change From Baseline in SBP and DBP
DBP: Day 3
-0.1 Millimeters of mercury
Standard Deviation 5.73
Period 3: Change From Baseline in SBP and DBP
DBP: Day 5
6.7 Millimeters of mercury
Standard Deviation 22.20
Period 3: Change From Baseline in SBP and DBP
DBP: Day 6
1.4 Millimeters of mercury
Standard Deviation 6.99
Period 3: Change From Baseline in SBP and DBP
DBP: Day 7
2.9 Millimeters of mercury
Standard Deviation 5.88
Period 3: Change From Baseline in SBP and DBP
DBP: Day 8
1.8 Millimeters of mercury
Standard Deviation 9.89
Period 3: Change From Baseline in SBP and DBP
DBP: Day 9
2.1 Millimeters of mercury
Standard Deviation 5.87
Period 3: Change From Baseline in SBP and DBP
DBP: Day 10
2.3 Millimeters of mercury
Standard Deviation 4.91
Period 3: Change From Baseline in SBP and DBP
DBP: Day 11
-0.1 Millimeters of mercury
Standard Deviation 5.43

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5

Population: Safety Population.

Pulse rate was measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Change From Baseline in Pulse Rate
Day 4
2.0 Beats per minute
Standard Deviation 8.46
Period 1: Change From Baseline in Pulse Rate
Day 5
-1.6 Beats per minute
Standard Deviation 5.08
Period 1: Change From Baseline in Pulse Rate
Day 2
-0.3 Beats per minute
Standard Deviation 4.30
Period 1: Change From Baseline in Pulse Rate
Day 3
-1.3 Beats per minute
Standard Deviation 4.63

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7

Population: Safety Population.

Pulse rate was measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Change From Baseline in Pulse Rate
Day 2
3.9 Beats per minute
Standard Deviation 8.54
Period 2: Change From Baseline in Pulse Rate
Day 3
5.4 Beats per minute
Standard Deviation 7.19
Period 2: Change From Baseline in Pulse Rate
Day 4
4.8 Beats per minute
Standard Deviation 7.50
Period 2: Change From Baseline in Pulse Rate
Day 5
4.2 Beats per minute
Standard Deviation 8.73
Period 2: Change From Baseline in Pulse Rate
Day 6
3.8 Beats per minute
Standard Deviation 6.51
Period 2: Change From Baseline in Pulse Rate
Day 7
2.7 Beats per minute
Standard Deviation 5.78

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11

Population: Safety Population.

Pulse rate was measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Change From Baseline in Pulse Rate
Day 4
0.3 Beats per minute
Standard Deviation 7.63
Period 3: Change From Baseline in Pulse Rate
Day 5
3.1 Beats per minute
Standard Deviation 7.79
Period 3: Change From Baseline in Pulse Rate
Day 8
2.3 Beats per minute
Standard Deviation 9.34
Period 3: Change From Baseline in Pulse Rate
Day 9
-0.8 Beats per minute
Standard Deviation 7.90
Period 3: Change From Baseline in Pulse Rate
Day 2
1.8 Beats per minute
Standard Deviation 5.65
Period 3: Change From Baseline in Pulse Rate
Day 3
2.2 Beats per minute
Standard Deviation 6.88
Period 3: Change From Baseline in Pulse Rate
Day 6
1.3 Beats per minute
Standard Deviation 6.97
Period 3: Change From Baseline in Pulse Rate
Day 7
-2.1 Beats per minute
Standard Deviation 5.94
Period 3: Change From Baseline in Pulse Rate
Day 10
-2.9 Beats per minute
Standard Deviation 5.34
Period 3: Change From Baseline in Pulse Rate
Day 11
1.7 Beats per minute
Standard Deviation 10.56

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5

Population: Safety Population.

Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Change From Baseline in Respiratory Rate
Day 2
-0.9 Breaths per minute
Standard Deviation 3.18
Period 1: Change From Baseline in Respiratory Rate
Day 3
0.3 Breaths per minute
Standard Deviation 2.05
Period 1: Change From Baseline in Respiratory Rate
Day 4
-1.5 Breaths per minute
Standard Deviation 3.06
Period 1: Change From Baseline in Respiratory Rate
Day 5
-0.8 Breaths per minute
Standard Deviation 2.29

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7

Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).

Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Change From Baseline in Respiratory Rate
Day 2, n=16
-0.5 Breaths per minute
Standard Deviation 2.58
Period 2: Change From Baseline in Respiratory Rate
Day 3, n=16
0.4 Breaths per minute
Standard Deviation 3.03
Period 2: Change From Baseline in Respiratory Rate
Day 4, n=16
-0.6 Breaths per minute
Standard Deviation 3.07
Period 2: Change From Baseline in Respiratory Rate
Day 5, n=15
1.3 Breaths per minute
Standard Deviation 2.47
Period 2: Change From Baseline in Respiratory Rate
Day 6, n=16
-0.4 Breaths per minute
Standard Deviation 2.55
Period 2: Change From Baseline in Respiratory Rate
Day 7, n=16
0.1 Breaths per minute
Standard Deviation 3.30

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11

Population: Safety Population.

Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Change From Baseline in Respiratory Rate
Day 6
0.6 Breaths per minute
Standard Deviation 3.24
Period 3: Change From Baseline in Respiratory Rate
Day 2
1.4 Breaths per minute
Standard Deviation 3.07
Period 3: Change From Baseline in Respiratory Rate
Day 3
0.5 Breaths per minute
Standard Deviation 3.39
Period 3: Change From Baseline in Respiratory Rate
Day 4
0.3 Breaths per minute
Standard Deviation 3.34
Period 3: Change From Baseline in Respiratory Rate
Day 5
-0.5 Breaths per minute
Standard Deviation 2.97
Period 3: Change From Baseline in Respiratory Rate
Day 7
0.3 Breaths per minute
Standard Deviation 3.09
Period 3: Change From Baseline in Respiratory Rate
Day 8
1.4 Breaths per minute
Standard Deviation 2.80
Period 3: Change From Baseline in Respiratory Rate
Day 9
-0.4 Breaths per minute
Standard Deviation 3.36
Period 3: Change From Baseline in Respiratory Rate
Day 10
1.4 Breaths per minute
Standard Deviation 2.80
Period 3: Change From Baseline in Respiratory Rate
Day 11
2.8 Breaths per minute
Standard Deviation 2.41

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5

Population: Safety Population.

Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Change From Baseline in Body Temperature
Day 2
-0.04 Degrees Celsius
Standard Deviation 0.326
Period 1: Change From Baseline in Body Temperature
Day 3
-0.14 Degrees Celsius
Standard Deviation 0.287
Period 1: Change From Baseline in Body Temperature
Day 4
-0.19 Degrees Celsius
Standard Deviation 0.370
Period 1: Change From Baseline in Body Temperature
Day 5
0.03 Degrees Celsius
Standard Deviation 0.275

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7

Population: Safety Population.

Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Change From Baseline in Body Temperature
Day 2
-0.14 Degrees Celsius
Standard Deviation 0.299
Period 2: Change From Baseline in Body Temperature
Day 3
-0.25 Degrees Celsius
Standard Deviation 0.415
Period 2: Change From Baseline in Body Temperature
Day 4
-0.19 Degrees Celsius
Standard Deviation 0.294
Period 2: Change From Baseline in Body Temperature
Day 5
-0.05 Degrees Celsius
Standard Deviation 0.363
Period 2: Change From Baseline in Body Temperature
Day 6
-0.13 Degrees Celsius
Standard Deviation 0.300
Period 2: Change From Baseline in Body Temperature
Day 7
-0.13 Degrees Celsius
Standard Deviation 0.373

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11

Population: Safety Population.

Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Change From Baseline in Body Temperature
Day 4
0.02 Degrees Celsius
Standard Deviation 0.229
Period 3: Change From Baseline in Body Temperature
Day 9
-0.10 Degrees Celsius
Standard Deviation 0.329
Period 3: Change From Baseline in Body Temperature
Day 10
-0.03 Degrees Celsius
Standard Deviation 0.291
Period 3: Change From Baseline in Body Temperature
Day 2
-0.08 Degrees Celsius
Standard Deviation 0.286
Period 3: Change From Baseline in Body Temperature
Day 3
-0.18 Degrees Celsius
Standard Deviation 0.423
Period 3: Change From Baseline in Body Temperature
Day 5
0.00 Degrees Celsius
Standard Deviation 0.175
Period 3: Change From Baseline in Body Temperature
Day 6
-0.03 Degrees Celsius
Standard Deviation 0.318
Period 3: Change From Baseline in Body Temperature
Day 7
0.06 Degrees Celsius
Standard Deviation 0.287
Period 3: Change From Baseline in Body Temperature
Day 8
-0.13 Degrees Celsius
Standard Deviation 0.458
Period 3: Change From Baseline in Body Temperature
Day 11
0.13 Degrees Celsius
Standard Deviation 0.302

SECONDARY outcome

Timeframe: Day 9

Population: Safety Population.

Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Basophils
0.045 10^9 cells per liter
Standard Deviation 0.0115
Period 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Eosinophils
0.232 10^9 cells per liter
Standard Deviation 0.1440
Period 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Lymphocytes
2.023 10^9 cells per liter
Standard Deviation 0.5931
Period 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Monocytes
0.512 10^9 cells per liter
Standard Deviation 0.1133
Period 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Neutrophils
3.038 10^9 cells per liter
Standard Deviation 0.7559
Period 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Platelet count
270.2 10^9 cells per liter
Standard Deviation 47.62

SECONDARY outcome

Timeframe: Day 7

Population: Safety Population.

Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Basophils
0.039 10^9 cells per liter
Standard Deviation 0.0134
Period 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Eosinophils
0.206 10^9 cells per liter
Standard Deviation 0.0960
Period 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Lymphocytes
1.869 10^9 cells per liter
Standard Deviation 0.4383
Period 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Monocytes
0.488 10^9 cells per liter
Standard Deviation 0.1081
Period 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Neutrophils
2.878 10^9 cells per liter
Standard Deviation 0.6859
Period 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Platelet count
264.2 10^9 cells per liter
Standard Deviation 48.37

SECONDARY outcome

Timeframe: Days 4, 7 and 10

Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).

Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 10: Lymphocytes, n=16
1.753 10^9 cells per liter
Standard Deviation 0.3450
Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 4: Monocytes, n=16
0.537 10^9 cells per liter
Standard Deviation 0.1821
Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 4: Basophils, n=16
0.043 10^9 cells per liter
Standard Deviation 0.0165
Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 7: Basophils, n=16
0.046 10^9 cells per liter
Standard Deviation 0.0196
Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 10: Basophils, n=16
0.042 10^9 cells per liter
Standard Deviation 0.0142
Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 4: Eosinophils, n=16
0.206 10^9 cells per liter
Standard Deviation 0.1120
Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 7: Eosinophils, n=16
0.211 10^9 cells per liter
Standard Deviation 0.1512
Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 10: Eosinophils, n=16
0.171 10^9 cells per liter
Standard Deviation 0.0874
Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 4: Lymphocytes, n=16
1.739 10^9 cells per liter
Standard Deviation 0.3701
Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 7: Lymphocytes, n=16
1.837 10^9 cells per liter
Standard Deviation 0.3916
Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 7: Monocytes, n=16
0.490 10^9 cells per liter
Standard Deviation 0.1157
Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 10: Monocytes, n=16
0.470 10^9 cells per liter
Standard Deviation 0.1128
Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 4: Neutrophils, n=16
3.321 10^9 cells per liter
Standard Deviation 1.4579
Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 7: Neutrophils, n=16
2.954 10^9 cells per liter
Standard Deviation 0.5600
Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 10: Neutrophils, n=16
3.082 10^9 cells per liter
Standard Deviation 0.6649
Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 4: Platelet count, n=16
259.3 10^9 cells per liter
Standard Deviation 46.03
Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 7: Platelet count, n=15
255.3 10^9 cells per liter
Standard Deviation 46.20
Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Day 10: Platelet count, n=16
258.3 10^9 cells per liter
Standard Deviation 42.92

SECONDARY outcome

Timeframe: Day 9

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: hemoglobin.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Absolute Values for Hematology Parameter: Hemoglobin
146.4 Grams per liter
Standard Deviation 8.02

SECONDARY outcome

Timeframe: Day 7

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: hemoglobin.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Absolute Values for Hematology Parameter: Hemoglobin
146.5 Grams per liter
Standard Deviation 8.68

SECONDARY outcome

Timeframe: Days 4, 7 and 10

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: hemoglobin.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Absolute Values for Hematology Parameter: Hemoglobin
Day 4
149.8 Grams per liter
Standard Deviation 8.74
Period 3: Absolute Values for Hematology Parameter: Hemoglobin
Day 7
147.1 Grams per liter
Standard Deviation 8.23
Period 3: Absolute Values for Hematology Parameter: Hemoglobin
Day 10
147.7 Grams per liter
Standard Deviation 9.17

SECONDARY outcome

Timeframe: Day 9

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: hematocrit.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Absolute Values for Hematology Parameter: Hematocrit
0.4419 Proportion of red blood cells in blood
Standard Deviation 0.01697

SECONDARY outcome

Timeframe: Day 7

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: hematocrit.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Absolute Values for Hematology Parameter: Hematocrit
0.4406 Proportion of red blood cells in blood
Standard Deviation 0.01887

SECONDARY outcome

Timeframe: Days 4, 7 and 10

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: hematocrit.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Absolute Values for Hematology Parameter: Hematocrit
Day 4
0.4441 Proportion of red blood cells in blood
Standard Deviation 0.01956
Period 3: Absolute Values for Hematology Parameter: Hematocrit
Day 7
0.4357 Proportion of red blood cells in blood
Standard Deviation 0.01924
Period 3: Absolute Values for Hematology Parameter: Hematocrit
Day 10
0.4364 Proportion of red blood cells in blood
Standard Deviation 0.02267

SECONDARY outcome

Timeframe: Day 9

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: erythrocytes.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Absolute Values for Hematology Parameter: Erythrocytes
5.143 Trillion cells per liter
Standard Deviation 0.3580

SECONDARY outcome

Timeframe: Day 7

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: erythrocytes.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Absolute Values for Hematology Parameter: Erythrocytes
5.179 Trillion cells per liter
Standard Deviation 0.3575

SECONDARY outcome

Timeframe: Days 4, 7 and 10

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: erythrocytes.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Absolute Values for Hematology Parameter: Erythrocytes
Day 4
5.194 Trillion cells per liter
Standard Deviation 0.3476
Period 3: Absolute Values for Hematology Parameter: Erythrocytes
Day 7
5.099 Trillion cells per liter
Standard Deviation 0.3798
Period 3: Absolute Values for Hematology Parameter: Erythrocytes
Day 10
5.124 Trillion cells per liter
Standard Deviation 0.3678

SECONDARY outcome

Timeframe: Day 9

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
86.22 Femtoliter
Standard Deviation 5.670

SECONDARY outcome

Timeframe: Day 7

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
85.36 Femtoliter
Standard Deviation 5.509

SECONDARY outcome

Timeframe: Days 4, 7 and 10

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 4
85.76 Femtoliter
Standard Deviation 5.323
Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 7
85.72 Femtoliter
Standard Deviation 5.117
Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 10
85.41 Femtoliter
Standard Deviation 5.030

SECONDARY outcome

Timeframe: Day 9

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
28.58 Picograms
Standard Deviation 2.446

SECONDARY outcome

Timeframe: Day 7

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
28.41 Picograms
Standard Deviation 2.385

SECONDARY outcome

Timeframe: Days 4, 7 and 10

Population: Safety Population.

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Day 4
28.96 Picograms
Standard Deviation 2.514
Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Day 7
28.96 Picograms
Standard Deviation 2.404
Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Day 10
28.93 Picograms
Standard Deviation 2.530

SECONDARY outcome

Timeframe: Day 9

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Glucose
5.165 Millimoles per liter
Standard Deviation 0.4788
Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Cholesterol
4.456 Millimoles per liter
Standard Deviation 0.6591
Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Triglycerides
1.107 Millimoles per liter
Standard Deviation 0.5362
Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Anion gap
9.2 Millimoles per liter
Standard Deviation 1.28
Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Calcium
2.393 Millimoles per liter
Standard Deviation 0.0781
Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Carbon dioxide
30.5 Millimoles per liter
Standard Deviation 1.15
Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Chloride
103.8 Millimoles per liter
Standard Deviation 2.32
Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Phosphate
1.244 Millimoles per liter
Standard Deviation 0.1658
Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Potassium
4.31 Millimoles per liter
Standard Deviation 0.427
Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Sodium
139.3 Millimoles per liter
Standard Deviation 2.52
Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood urea nitrogen
5.406 Millimoles per liter
Standard Deviation 0.7575

SECONDARY outcome

Timeframe: Day 7

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Sodium
139.6 Millimoles per liter
Standard Deviation 1.90
Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Glucose
4.916 Millimoles per liter
Standard Deviation 0.4825
Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Cholesterol
4.187 Millimoles per liter
Standard Deviation 0.6783
Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Triglycerides
1.194 Millimoles per liter
Standard Deviation 0.7294
Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Anion gap
11.4 Millimoles per liter
Standard Deviation 1.20
Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Calcium
2.406 Millimoles per liter
Standard Deviation 0.0772
Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Carbon dioxide
29.3 Millimoles per liter
Standard Deviation 1.57
Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Chloride
103.1 Millimoles per liter
Standard Deviation 2.35
Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Phosphate
1.281 Millimoles per liter
Standard Deviation 0.1510
Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Potassium
4.23 Millimoles per liter
Standard Deviation 0.249
Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood urea nitrogen
5.065 Millimoles per liter
Standard Deviation 0.6775

SECONDARY outcome

Timeframe: Days 4, 7 and 10

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 10: Glucose
4.849 Millimoles per liter
Standard Deviation 0.3858
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 4: Cholesterol
4.283 Millimoles per liter
Standard Deviation 0.8001
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 4: Calcium
2.404 Millimoles per liter
Standard Deviation 0.0855
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 10: Sodium
140.1 Millimoles per liter
Standard Deviation 2.11
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 10: Blood urea nitrogen
5.039 Millimoles per liter
Standard Deviation 0.8264
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 4: Glucose
4.978 Millimoles per liter
Standard Deviation 0.4655
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 7: Glucose
5.018 Millimoles per liter
Standard Deviation 0.3977
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 7: Cholesterol
4.179 Millimoles per liter
Standard Deviation 0.7438
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 10: Cholesterol
4.157 Millimoles per liter
Standard Deviation 0.8037
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 4: Triglycerides
1.228 Millimoles per liter
Standard Deviation 0.6403
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 7: Triglycerides
1.100 Millimoles per liter
Standard Deviation 0.5887
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 10: Triglycerides
1.289 Millimoles per liter
Standard Deviation 0.6625
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 4: Anion gap
7.3 Millimoles per liter
Standard Deviation 1.01
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 7: Anion gap
11.4 Millimoles per liter
Standard Deviation 1.75
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 10: Anion gap
12.1 Millimoles per liter
Standard Deviation 1.31
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 7: Calcium
2.433 Millimoles per liter
Standard Deviation 0.0827
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 10: Calcium
2.441 Millimoles per liter
Standard Deviation 0.0681
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 4: Carbon dioxide
30.2 Millimoles per liter
Standard Deviation 1.56
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 7: Carbon dioxide
29.4 Millimoles per liter
Standard Deviation 1.15
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 10: Carbon dioxide
30.3 Millimoles per liter
Standard Deviation 1.53
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 4: Chloride
103.8 Millimoles per liter
Standard Deviation 2.77
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 7: Chloride
102.8 Millimoles per liter
Standard Deviation 2.07
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 10: Chloride
101.9 Millimoles per liter
Standard Deviation 2.02
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 4: Phosphate
1.276 Millimoles per liter
Standard Deviation 0.1304
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 7: Phosphate
1.268 Millimoles per liter
Standard Deviation 0.1802
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 10: Phosphate
1.229 Millimoles per liter
Standard Deviation 0.1213
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 4: Potassium
4.19 Millimoles per liter
Standard Deviation 0.150
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 7: Potassium
4.19 Millimoles per liter
Standard Deviation 0.217
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 10: Potassium
4.29 Millimoles per liter
Standard Deviation 0.275
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 4: Sodium
137.6 Millimoles per liter
Standard Deviation 2.06
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 7: Sodium
139.5 Millimoles per liter
Standard Deviation 2.56
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 4: Blood urea nitrogen
5.119 Millimoles per liter
Standard Deviation 0.8548
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Day 7: Blood urea nitrogen
4.887 Millimoles per liter
Standard Deviation 0.6388

SECONDARY outcome

Timeframe: Day 9

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Creatine kinase
101.3 International units per liter
Standard Deviation 57.10
Period 1: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Lactate dehydrogenase
107.4 International units per liter
Standard Deviation 14.33
Period 1: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
ALT
21.0 International units per liter
Standard Deviation 10.71
Period 1: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
ALP
57.4 International units per liter
Standard Deviation 8.74
Period 1: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
AST
16.6 International units per liter
Standard Deviation 3.86
Period 1: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Gamma-glutamyl transferase
21.1 International units per liter
Standard Deviation 9.24

SECONDARY outcome

Timeframe: Day 7

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Creatine kinase
123.9 International units per liter
Standard Deviation 112.28
Period 2: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Lactate dehydrogenase
116.5 International units per liter
Standard Deviation 15.10
Period 2: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
ALT
20.4 International units per liter
Standard Deviation 9.88
Period 2: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
ALP
59.3 International units per liter
Standard Deviation 9.19
Period 2: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
AST
16.8 International units per liter
Standard Deviation 3.80
Period 2: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Gamma-glutamyl transferase
20.3 International units per liter
Standard Deviation 8.44

SECONDARY outcome

Timeframe: Days 4, 7 and 10

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 4: Gamma-glutamyl transferase
19.5 International units per liter
Standard Deviation 8.38
Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 4: Creatine kinase
110.3 International units per liter
Standard Deviation 67.02
Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 7: Creatine kinase
105.3 International units per liter
Standard Deviation 63.83
Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 10: Creatine kinase
100.3 International units per liter
Standard Deviation 50.51
Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 4: Lactate dehydrogenase
122.4 International units per liter
Standard Deviation 16.26
Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 7: Lactate dehydrogenase
115.6 International units per liter
Standard Deviation 15.47
Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 10: Lactate dehydrogenase
116.6 International units per liter
Standard Deviation 18.79
Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 4: ALT
21.4 International units per liter
Standard Deviation 11.98
Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 7: ALT
21.1 International units per liter
Standard Deviation 12.00
Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 10: ALT
22.3 International units per liter
Standard Deviation 12.93
Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 4: ALP
57.8 International units per liter
Standard Deviation 9.34
Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 7: ALP
58.8 International units per liter
Standard Deviation 9.63
Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 10: ALP
60.1 International units per liter
Standard Deviation 9.07
Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 4: AST
17.7 International units per liter
Standard Deviation 5.12
Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 7: AST
16.3 International units per liter
Standard Deviation 4.78
Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 10: AST
17.1 International units per liter
Standard Deviation 4.55
Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 7: Gamma-glutamyl transferase
20.1 International units per liter
Standard Deviation 8.35
Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Day 10: Gamma-glutamyl transferase
20.8 International units per liter
Standard Deviation 9.13

SECONDARY outcome

Timeframe: Day 9

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Urate
321.9 Micromoles per liter
Standard Deviation 64.43
Period 1: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Creatinine
90.28 Micromoles per liter
Standard Deviation 11.281
Period 1: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Bilirubin
9.14 Micromoles per liter
Standard Deviation 2.423
Period 1: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Direct bilirubin
1.87 Micromoles per liter
Standard Deviation 0.551

SECONDARY outcome

Timeframe: Day 7

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Urate
314.8 Micromoles per liter
Standard Deviation 69.34
Period 2: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Creatinine
86.92 Micromoles per liter
Standard Deviation 11.567
Period 2: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Bilirubin
9.41 Micromoles per liter
Standard Deviation 3.014
Period 2: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Direct bilirubin
1.93 Micromoles per liter
Standard Deviation 0.704

SECONDARY outcome

Timeframe: Days 4, 7 and 10

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Day 4: Urate
314.8 Micromoles per liter
Standard Deviation 65.44
Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Day 7: Urate
299.3 Micromoles per liter
Standard Deviation 62.85
Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Day 10: Urate
313.4 Micromoles per liter
Standard Deviation 60.33
Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Day 4: Creatinine
94.82 Micromoles per liter
Standard Deviation 13.650
Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Day 7: Creatinine
96.81 Micromoles per liter
Standard Deviation 12.861
Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Day 10: Creatinine
88.91 Micromoles per liter
Standard Deviation 12.545
Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Day 4: Bilirubin
11.64 Micromoles per liter
Standard Deviation 4.856
Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Day 7: Bilirubin
9.19 Micromoles per liter
Standard Deviation 2.511
Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Day 10: Bilirubin
10.83 Micromoles per liter
Standard Deviation 3.796
Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Day 4: Direct bilirubin
2.26 Micromoles per liter
Standard Deviation 0.995
Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Day 7: Direct bilirubin
1.74 Micromoles per liter
Standard Deviation 0.617
Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Day 10: Direct bilirubin
2.15 Micromoles per liter
Standard Deviation 0.784

SECONDARY outcome

Timeframe: Day 9

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Albumin
44.1 Grams per liter
Standard Deviation 3.32
Period 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Globulin
27.9 Grams per liter
Standard Deviation 3.59
Period 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Protein
71.9 Grams per liter
Standard Deviation 4.63

SECONDARY outcome

Timeframe: Day 7

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Albumin
44.9 Grams per liter
Standard Deviation 3.13
Period 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Globulin
26.8 Grams per liter
Standard Deviation 3.78
Period 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Protein
71.8 Grams per liter
Standard Deviation 4.73

SECONDARY outcome

Timeframe: Days 4, 7 and 10

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Day 4: Albumin
45.9 Grams per liter
Standard Deviation 3.12
Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Day 7: Albumin
45.1 Grams per liter
Standard Deviation 2.83
Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Day 10: Albumin
45.3 Grams per liter
Standard Deviation 2.80
Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Day 4: Globulin
25.9 Grams per liter
Standard Deviation 3.52
Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Day 7: Globulin
27.8 Grams per liter
Standard Deviation 3.49
Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Day 10: Globulin
27.3 Grams per liter
Standard Deviation 3.34
Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Day 4: Protein
71.8 Grams per liter
Standard Deviation 3.89
Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Day 7: Protein
72.9 Grams per liter
Standard Deviation 4.28
Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Day 10: Protein
72.6 Grams per liter
Standard Deviation 4.11

SECONDARY outcome

Timeframe: Day 9

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: amylase and lipase.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Absolute Values for Chemistry Parameters: Amylase, Lipase
Amylase
59.6 Units per liter
Standard Deviation 21.96
Period 1: Absolute Values for Chemistry Parameters: Amylase, Lipase
Lipase
22.4 Units per liter
Standard Deviation 8.57

SECONDARY outcome

Timeframe: Day 7

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: amylase and lipase.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Absolute Values for Chemistry Parameters: Amylase, Lipase
Amylase
56.8 Units per liter
Standard Deviation 19.06
Period 2: Absolute Values for Chemistry Parameters: Amylase, Lipase
Lipase
21.7 Units per liter
Standard Deviation 7.34

SECONDARY outcome

Timeframe: Days 4, 7 and 10

Population: Safety Population.

Blood samples were collected to analyze the chemistry parameters: amylase and lipase.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Absolute Values for Chemistry Parameters: Amylase, Lipase
Day 4: Amylase
55.3 Units per liter
Standard Deviation 18.81
Period 3: Absolute Values for Chemistry Parameters: Amylase, Lipase
Day 7: Amylase
56.9 Units per liter
Standard Deviation 21.03
Period 3: Absolute Values for Chemistry Parameters: Amylase, Lipase
Day 10: Amylase
55.9 Units per liter
Standard Deviation 20.57
Period 3: Absolute Values for Chemistry Parameters: Amylase, Lipase
Day 4: Lipase
26.4 Units per liter
Standard Deviation 11.10
Period 3: Absolute Values for Chemistry Parameters: Amylase, Lipase
Day 7: Lipase
20.9 Units per liter
Standard Deviation 9.12
Period 3: Absolute Values for Chemistry Parameters: Amylase, Lipase
Day 10: Lipase
21.8 Units per liter
Standard Deviation 9.25

SECONDARY outcome

Timeframe: Day 9

Population: Safety Population.

Urine samples were collected to analyze the urinalysis parameter: 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.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Absolute Values for Urinalysis Parameter: Specific Gravity
1.0181 Ratio
Standard Deviation 0.00662

SECONDARY outcome

Timeframe: Day 7

Population: Safety Population.

Urine samples were collected to analyze the urinalysis parameter: 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.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Absolute Values for Urinalysis Parameter: Specific Gravity
1.0176 Ratio
Standard Deviation 0.00552

SECONDARY outcome

Timeframe: Days 4, 7 and 10

Population: Safety Population.

Urine samples were collected to analyze the urinalysis parameter: 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.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Absolute Values for Urinalysis Parameter: Specific Gravity
Day 4
1.0179 Ratio
Standard Deviation 0.00712
Period 3: Absolute Values for Urinalysis Parameter: Specific Gravity
Day 7
1.0169 Ratio
Standard Deviation 0.00640
Period 3: Absolute Values for Urinalysis Parameter: Specific Gravity
Day 10
1.0160 Ratio
Standard Deviation 0.00747

SECONDARY outcome

Timeframe: Day 9

Population: Safety Population.

Urine samples were collected to analyze the urinalysis parameter: urobilinogen.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Absolute Values for Urinalysis Parameter: Urobilinogen
3.3860 Micromoles per liter
Standard Deviation 0.00000

SECONDARY outcome

Timeframe: Day 7

Population: Safety Population.

Urine samples were collected to analyze the urinalysis parameter: urobilinogen.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Absolute Values for Urinalysis Parameter: Urobilinogen
3.3860 Micromoles per liter
Standard Deviation 0.00000

SECONDARY outcome

Timeframe: Days 4, 7 and 10

Population: Safety Population.

Urine samples were collected to analyze the urinalysis parameter: urobilinogen.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Absolute Values for Urinalysis Parameter: Urobilinogen
Day 4
3.3860 Micromoles per liter
Standard Deviation 0.00000
Period 3: Absolute Values for Urinalysis Parameter: Urobilinogen
Day 7
3.3860 Micromoles per liter
Standard Deviation 0.00000
Period 3: Absolute Values for Urinalysis Parameter: Urobilinogen
Day 10
3.3860 Micromoles per liter
Standard Deviation 0.00000

SECONDARY outcome

Timeframe: Day 9

Population: Safety Population.

Urine samples were collected to analyze the urinalysis parameter: 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).

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Absolute Values for Urinalysis Parameter: pH
5.88 pH
Standard Deviation 0.465

SECONDARY outcome

Timeframe: Day 7

Population: Safety Population.

Urine samples were collected to analyze the urinalysis parameter: 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).

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Absolute Values for Urinalysis Parameter: pH
6.00 pH
Standard Deviation 0.548

SECONDARY outcome

Timeframe: Days 4, 7 and 10

Population: Safety Population.

Urine samples were collected to analyze the urinalysis parameter: 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).

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Absolute Values for Urinalysis Parameter: pH
Day 4
6.03 pH
Standard Deviation 0.591
Period 3: Absolute Values for Urinalysis Parameter: pH
Day 7
5.88 pH
Standard Deviation 0.387
Period 3: Absolute Values for Urinalysis Parameter: pH
Day 10
6.16 pH
Standard Deviation 0.473

SECONDARY outcome

Timeframe: Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours

Population: Safety Population.

Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 5, 2 hours
388.6 Milliseconds
Standard Deviation 14.47
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 5, 4 hours
392.7 Milliseconds
Standard Deviation 14.11
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 1, 2 hours
159.1 Milliseconds
Standard Deviation 14.42
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 1, 4 hours
161.3 Milliseconds
Standard Deviation 16.51
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 5, Pre-dose
164.3 Milliseconds
Standard Deviation 14.87
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 5, 2 hours
160.9 Milliseconds
Standard Deviation 11.34
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 5, 4 hours
161.5 Milliseconds
Standard Deviation 12.66
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 1, 2 hours
95.2 Milliseconds
Standard Deviation 9.59
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 1, 4 hours
94.7 Milliseconds
Standard Deviation 10.90
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 5, Pre-dose
92.6 Milliseconds
Standard Deviation 8.39
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 5, 2 hours
94.2 Milliseconds
Standard Deviation 10.78
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 5, 4 hours
94.0 Milliseconds
Standard Deviation 9.26
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 1, 2 hours
386.4 Milliseconds
Standard Deviation 16.06
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 1, 4 hours
401.8 Milliseconds
Standard Deviation 19.94
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 5, Pre-dose
385.1 Milliseconds
Standard Deviation 13.96
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 5, 2 hours
375.6 Milliseconds
Standard Deviation 11.46
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 5, 4 hours
393.1 Milliseconds
Standard Deviation 18.80
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 1, 2 hours
391.6 Milliseconds
Standard Deviation 11.37
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 1, 4 hours
395.0 Milliseconds
Standard Deviation 12.90
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 5, Pre-dose
389.5 Milliseconds
Standard Deviation 10.92
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 1, 2 hours
393.1 Milliseconds
Standard Deviation 15.31
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 1, 4 hours
390.2 Milliseconds
Standard Deviation 16.01
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 5, Pre-dose
390.9 Milliseconds
Standard Deviation 14.91
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 5, 2 hours
394.2 Milliseconds
Standard Deviation 21.59
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 5, 4 hours
391.7 Milliseconds
Standard Deviation 19.71

SECONDARY outcome

Timeframe: Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours

Population: Safety Population.

Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 1, 2 hours
165.1 Milliseconds
Standard Deviation 15.46
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 1, 4 hours
165.4 Milliseconds
Standard Deviation 14.32
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 5, Pre-dose
166.3 Milliseconds
Standard Deviation 16.89
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 5, 2 hours
165.0 Milliseconds
Standard Deviation 19.90
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 5, 4 hours
162.0 Milliseconds
Standard Deviation 13.64
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 1, 2 hours
94.1 Milliseconds
Standard Deviation 9.66
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 1, 4 hours
92.9 Milliseconds
Standard Deviation 9.20
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 5, Pre-dose
94.3 Milliseconds
Standard Deviation 10.12
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 5, 2 hours
93.9 Milliseconds
Standard Deviation 9.00
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 5, 4 hours
94.7 Milliseconds
Standard Deviation 8.51
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 1, 2 hours
381.8 Milliseconds
Standard Deviation 14.37
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 1, 4 hours
394.4 Milliseconds
Standard Deviation 19.18
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 5, Pre-dose
392.6 Milliseconds
Standard Deviation 23.20
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 5, 2 hours
382.6 Milliseconds
Standard Deviation 17.13
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 5, 4 hours
396.0 Milliseconds
Standard Deviation 21.45
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 1, 2 hours
390.0 Milliseconds
Standard Deviation 13.74
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 1, 4 hours
394.4 Milliseconds
Standard Deviation 12.38
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 5, Pre-dose
397.9 Milliseconds
Standard Deviation 14.64
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 5, 2 hours
395.0 Milliseconds
Standard Deviation 14.70
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 5, 4 hours
401.5 Milliseconds
Standard Deviation 12.66
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 1, 2 hours
393.3 Milliseconds
Standard Deviation 18.57
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 1, 4 hours
393.4 Milliseconds
Standard Deviation 18.53
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 5, Pre-dose
399.2 Milliseconds
Standard Deviation 16.61
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 5, 2 hours
400.7 Milliseconds
Standard Deviation 20.02
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 5, 4 hours
403.2 Milliseconds
Standard Deviation 13.41

SECONDARY outcome

Timeframe: Day 1: 2 hours, 4 hours; Days 4, 5 and 7: Pre-dose, 2 hours and 4 hours; Day 10

Population: Safety Population.

Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 5, 2 hours
162.8 Milliseconds
Standard Deviation 12.71
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 1, 2 hours
167.9 Milliseconds
Standard Deviation 13.86
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 1, 4 hours
164.1 Milliseconds
Standard Deviation 15.12
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 4, Pre-dose
165.6 Milliseconds
Standard Deviation 16.02
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 4, 2 hours
166.9 Milliseconds
Standard Deviation 15.67
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 4, 4 hours
163.1 Milliseconds
Standard Deviation 15.13
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 5, Pre-dose
164.6 Milliseconds
Standard Deviation 18.30
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 5, 4 hours
163.3 Milliseconds
Standard Deviation 14.96
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 7, Pre-dose
169.6 Milliseconds
Standard Deviation 17.47
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 7, 2 hours
165.0 Milliseconds
Standard Deviation 15.69
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 7, 4 hours
165.6 Milliseconds
Standard Deviation 15.00
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
PR Interval: Day 10
168.3 Milliseconds
Standard Deviation 17.14
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 1, 2 hours
95.9 Milliseconds
Standard Deviation 10.49
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 1, 4 hours
92.8 Milliseconds
Standard Deviation 8.76
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 4, Pre-dose
96.8 Milliseconds
Standard Deviation 9.41
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 4, 2 hours
93.5 Milliseconds
Standard Deviation 8.21
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 4, 4 hours
95.3 Milliseconds
Standard Deviation 8.79
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 5, Pre-dose
96.6 Milliseconds
Standard Deviation 9.77
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 5, 2 hours
96.1 Milliseconds
Standard Deviation 11.66
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 5, 4 hours
94.3 Milliseconds
Standard Deviation 9.56
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 7, Pre-dose
95.4 Milliseconds
Standard Deviation 9.44
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 7, 2 hours
95.1 Milliseconds
Standard Deviation 9.52
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 7, 4 hours
94.4 Milliseconds
Standard Deviation 9.30
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QRS Duration: Day 10
96.5 Milliseconds
Standard Deviation 9.14
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 1, 2 hours
380.0 Milliseconds
Standard Deviation 12.90
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 1, 4 hours
392.3 Milliseconds
Standard Deviation 16.39
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 4, Pre-dose
389.2 Milliseconds
Standard Deviation 18.65
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 4, 2 hours
376.6 Milliseconds
Standard Deviation 18.49
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 4, 4 hours
395.3 Milliseconds
Standard Deviation 17.89
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 5, Pre-dose
386.4 Milliseconds
Standard Deviation 18.49
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 5, 2 hours
380.9 Milliseconds
Standard Deviation 13.91
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 5, 4 hours
391.8 Milliseconds
Standard Deviation 20.53
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 7, Pre-dose
391.0 Milliseconds
Standard Deviation 21.99
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 7, 2 hours
382.3 Milliseconds
Standard Deviation 13.85
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 7, 4 hours
395.8 Milliseconds
Standard Deviation 20.94
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QT Interval: Day 10
392.9 Milliseconds
Standard Deviation 14.54
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 1, 2 hours
392.7 Milliseconds
Standard Deviation 11.45
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 1, 4 hours
399.7 Milliseconds
Standard Deviation 10.37
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 4, Pre-dose
395.8 Milliseconds
Standard Deviation 13.94
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 4, 2 hours
390.6 Milliseconds
Standard Deviation 12.33
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 4, 4 hours
401.2 Milliseconds
Standard Deviation 13.55
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 5, Pre-dose
399.2 Milliseconds
Standard Deviation 14.92
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 5, 2 hours
394.3 Milliseconds
Standard Deviation 12.83
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 5, 4 hours
401.7 Milliseconds
Standard Deviation 11.91
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 7, Pre-dose
395.1 Milliseconds
Standard Deviation 12.91
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 7, 2 hours
393.7 Milliseconds
Standard Deviation 12.69
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 7, 4 hours
396.8 Milliseconds
Standard Deviation 13.47
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcF Interval: Day 10
394.8 Milliseconds
Standard Deviation 13.08
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 1, 2 hours
398.4 Milliseconds
Standard Deviation 15.81
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 1, 4 hours
402.0 Milliseconds
Standard Deviation 15.46
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 4, Pre-dose
398.4 Milliseconds
Standard Deviation 17.82
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 4, 2 hours
394.0 Milliseconds
Standard Deviation 21.41
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 4, 4 hours
403.1 Milliseconds
Standard Deviation 17.67
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 5, Pre-dose
405.1 Milliseconds
Standard Deviation 23.00
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 5, 2 hours
400.1 Milliseconds
Standard Deviation 18.05
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 5, 4 hours
405.9 Milliseconds
Standard Deviation 16.27
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 7, Pre-dose
396.6 Milliseconds
Standard Deviation 17.50
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 7, 2 hours
398.9 Milliseconds
Standard Deviation 21.21
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 7, 4 hours
396.0 Milliseconds
Standard Deviation 18.10
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
QTcB Interval: Day 10
394.8 Milliseconds
Standard Deviation 18.39

SECONDARY outcome

Timeframe: Days 2, 3, 4 and 5

Population: Safety Population.

SBP and DBP were measured in the semi-recumbent position with a completely automated device.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Absolute Values for SBP and DBP
SBP: Day 2
118.8 Millimeters of mercury
Standard Deviation 8.57
Period 1: Absolute Values for SBP and DBP
SBP: Day 3
114.9 Millimeters of mercury
Standard Deviation 8.09
Period 1: Absolute Values for SBP and DBP
SBP: Day 4
119.0 Millimeters of mercury
Standard Deviation 9.81
Period 1: Absolute Values for SBP and DBP
SBP: Day 5
109.1 Millimeters of mercury
Standard Deviation 7.16
Period 1: Absolute Values for SBP and DBP
DBP: Day 2
76.1 Millimeters of mercury
Standard Deviation 6.53
Period 1: Absolute Values for SBP and DBP
DBP: Day 3
72.7 Millimeters of mercury
Standard Deviation 8.32
Period 1: Absolute Values for SBP and DBP
DBP: Day 4
74.1 Millimeters of mercury
Standard Deviation 8.58
Period 1: Absolute Values for SBP and DBP
DBP: Day 5
69.2 Millimeters of mercury
Standard Deviation 9.77

SECONDARY outcome

Timeframe: Days 2, 3, 4, 5, 6 and 7

Population: Safety Population.

SBP and DBP were measured in the semi-recumbent position with a completely automated device.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Absolute Values for SBP and DBP
SBP: Day 2
115.8 Millimeters of mercury
Standard Deviation 7.15
Period 2: Absolute Values for SBP and DBP
SBP: Day 3
115.3 Millimeters of mercury
Standard Deviation 7.57
Period 2: Absolute Values for SBP and DBP
SBP: Day 4
117.1 Millimeters of mercury
Standard Deviation 8.74
Period 2: Absolute Values for SBP and DBP
SBP: Day 5
113.6 Millimeters of mercury
Standard Deviation 7.35
Period 2: Absolute Values for SBP and DBP
SBP: Day 6
113.9 Millimeters of mercury
Standard Deviation 8.29
Period 2: Absolute Values for SBP and DBP
SBP: Day 7
114.6 Millimeters of mercury
Standard Deviation 5.73
Period 2: Absolute Values for SBP and DBP
DBP: Day 2
69.6 Millimeters of mercury
Standard Deviation 8.50
Period 2: Absolute Values for SBP and DBP
DBP: Day 3
71.1 Millimeters of mercury
Standard Deviation 7.65
Period 2: Absolute Values for SBP and DBP
DBP: Day 4
69.6 Millimeters of mercury
Standard Deviation 5.24
Period 2: Absolute Values for SBP and DBP
DBP: Day 5
68.8 Millimeters of mercury
Standard Deviation 6.49
Period 2: Absolute Values for SBP and DBP
DBP: Day 6
70.3 Millimeters of mercury
Standard Deviation 7.02
Period 2: Absolute Values for SBP and DBP
DBP: Day 7
70.4 Millimeters of mercury
Standard Deviation 6.65

SECONDARY outcome

Timeframe: Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11

Population: Safety Population.

SBP and DBP were measured in the semi-recumbent position with a completely automated device.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Absolute Values for SBP and DBP
SBP: Day 2
115.8 Millimeters of mercury
Standard Deviation 8.12
Period 3: Absolute Values for SBP and DBP
SBP: Day 3
112.5 Millimeters of mercury
Standard Deviation 5.81
Period 3: Absolute Values for SBP and DBP
SBP: Day 4
112.6 Millimeters of mercury
Standard Deviation 6.11
Period 3: Absolute Values for SBP and DBP
SBP: Day 5
119.4 Millimeters of mercury
Standard Deviation 19.70
Period 3: Absolute Values for SBP and DBP
SBP: Day 6
114.4 Millimeters of mercury
Standard Deviation 7.45
Period 3: Absolute Values for SBP and DBP
SBP: Day 7
113.8 Millimeters of mercury
Standard Deviation 8.13
Period 3: Absolute Values for SBP and DBP
SBP: Day 8
113.9 Millimeters of mercury
Standard Deviation 6.72
Period 3: Absolute Values for SBP and DBP
SBP: Day 9
113.6 Millimeters of mercury
Standard Deviation 7.67
Period 3: Absolute Values for SBP and DBP
SBP: Day 10
111.6 Millimeters of mercury
Standard Deviation 6.38
Period 3: Absolute Values for SBP and DBP
SBP: Day 11
112.4 Millimeters of mercury
Standard Deviation 7.69
Period 3: Absolute Values for SBP and DBP
DBP: Day 2
69.0 Millimeters of mercury
Standard Deviation 6.46
Period 3: Absolute Values for SBP and DBP
DBP: Day 3
67.7 Millimeters of mercury
Standard Deviation 6.52
Period 3: Absolute Values for SBP and DBP
DBP: Day 4
68.9 Millimeters of mercury
Standard Deviation 6.33
Period 3: Absolute Values for SBP and DBP
DBP: Day 5
74.4 Millimeters of mercury
Standard Deviation 21.90
Period 3: Absolute Values for SBP and DBP
DBP: Day 6
69.2 Millimeters of mercury
Standard Deviation 8.27
Period 3: Absolute Values for SBP and DBP
DBP: Day 7
70.6 Millimeters of mercury
Standard Deviation 5.78
Period 3: Absolute Values for SBP and DBP
DBP: Day 8
69.5 Millimeters of mercury
Standard Deviation 9.34
Period 3: Absolute Values for SBP and DBP
DBP: Day 9
69.8 Millimeters of mercury
Standard Deviation 5.98
Period 3: Absolute Values for SBP and DBP
DBP: Day 10
70.0 Millimeters of mercury
Standard Deviation 5.14
Period 3: Absolute Values for SBP and DBP
DBP: Day 11
67.7 Millimeters of mercury
Standard Deviation 4.32

SECONDARY outcome

Timeframe: Days 2, 3, 4 and 5

Population: Safety Population.

Pulse rate was measured in the semi-recumbent position with a completely automated device.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Absolute Values for Pulse Rate
Day 2
67.8 Beats per minute
Standard Deviation 8.47
Period 1: Absolute Values for Pulse Rate
Day 3
66.8 Beats per minute
Standard Deviation 6.68
Period 1: Absolute Values for Pulse Rate
Day 4
70.1 Beats per minute
Standard Deviation 10.57
Period 1: Absolute Values for Pulse Rate
Day 5
66.4 Beats per minute
Standard Deviation 8.21

SECONDARY outcome

Timeframe: Days 2, 3, 4, 5, 6 and 7

Population: Safety Population.

Pulse rate was measured in the semi-recumbent position with a completely automated device.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Absolute Values for Pulse Rate
Day 2
68.3 Beats per minute
Standard Deviation 9.75
Period 2: Absolute Values for Pulse Rate
Day 3
69.7 Beats per minute
Standard Deviation 8.65
Period 2: Absolute Values for Pulse Rate
Day 4
69.1 Beats per minute
Standard Deviation 8.21
Period 2: Absolute Values for Pulse Rate
Day 5
68.5 Beats per minute
Standard Deviation 11.14
Period 2: Absolute Values for Pulse Rate
Day 6
68.1 Beats per minute
Standard Deviation 8.88
Period 2: Absolute Values for Pulse Rate
Day 7
67.0 Beats per minute
Standard Deviation 8.95

SECONDARY outcome

Timeframe: Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11

Population: Safety Population.

Pulse rate was measured in the semi-recumbent position with a completely automated device.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Absolute Values for Pulse Rate
Day 9
65.9 Beats per minute
Standard Deviation 10.12
Period 3: Absolute Values for Pulse Rate
Day 2
68.4 Beats per minute
Standard Deviation 9.79
Period 3: Absolute Values for Pulse Rate
Day 3
68.9 Beats per minute
Standard Deviation 8.63
Period 3: Absolute Values for Pulse Rate
Day 4
66.9 Beats per minute
Standard Deviation 9.26
Period 3: Absolute Values for Pulse Rate
Day 5
69.8 Beats per minute
Standard Deviation 10.57
Period 3: Absolute Values for Pulse Rate
Day 6
67.9 Beats per minute
Standard Deviation 10.12
Period 3: Absolute Values for Pulse Rate
Day 7
64.6 Beats per minute
Standard Deviation 8.02
Period 3: Absolute Values for Pulse Rate
Day 8
69.0 Beats per minute
Standard Deviation 12.02
Period 3: Absolute Values for Pulse Rate
Day 10
63.8 Beats per minute
Standard Deviation 8.53
Period 3: Absolute Values for Pulse Rate
Day 11
68.4 Beats per minute
Standard Deviation 12.27

SECONDARY outcome

Timeframe: Days 2, 3, 4 and 5

Population: Safety Population.

Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Absolute Values for Respiratory Rate
Day 2
13.5 Breaths per minute
Standard Deviation 1.37
Period 1: Absolute Values for Respiratory Rate
Day 3
14.6 Breaths per minute
Standard Deviation 2.16
Period 1: Absolute Values for Respiratory Rate
Day 4
12.9 Breaths per minute
Standard Deviation 1.78
Period 1: Absolute Values for Respiratory Rate
Day 5
13.6 Breaths per minute
Standard Deviation 2.22

SECONDARY outcome

Timeframe: Days 2, 3, 4, 5, 6 and 7

Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).

Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Absolute Values for Respiratory Rate
Day 2, n=16
13.6 Breaths per minute
Standard Deviation 0.81
Period 2: Absolute Values for Respiratory Rate
Day 3, n=16
14.5 Breaths per minute
Standard Deviation 2.00
Period 2: Absolute Values for Respiratory Rate
Day 4, n=16
13.5 Breaths per minute
Standard Deviation 1.15
Period 2: Absolute Values for Respiratory Rate
Day 5, n=15
15.3 Breaths per minute
Standard Deviation 2.09
Period 2: Absolute Values for Respiratory Rate
Day 6, n=16
13.8 Breaths per minute
Standard Deviation 2.52
Period 2: Absolute Values for Respiratory Rate
Day 7, n=16
14.3 Breaths per minute
Standard Deviation 2.18

SECONDARY outcome

Timeframe: Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11

Population: Safety Population.

Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Absolute Values for Respiratory Rate
Day 2
15.0 Breaths per minute
Standard Deviation 2.42
Period 3: Absolute Values for Respiratory Rate
Day 3
14.1 Breaths per minute
Standard Deviation 1.54
Period 3: Absolute Values for Respiratory Rate
Day 4
13.9 Breaths per minute
Standard Deviation 2.96
Period 3: Absolute Values for Respiratory Rate
Day 5
13.1 Breaths per minute
Standard Deviation 1.45
Period 3: Absolute Values for Respiratory Rate
Day 6
14.3 Breaths per minute
Standard Deviation 2.05
Period 3: Absolute Values for Respiratory Rate
Day 7
13.9 Breaths per minute
Standard Deviation 1.86
Period 3: Absolute Values for Respiratory Rate
Day 8
15.0 Breaths per minute
Standard Deviation 1.03
Period 3: Absolute Values for Respiratory Rate
Day 9
13.3 Breaths per minute
Standard Deviation 3.00
Period 3: Absolute Values for Respiratory Rate
Day 10
15.0 Breaths per minute
Standard Deviation 1.79
Period 3: Absolute Values for Respiratory Rate
Day 11
16.4 Breaths per minute
Standard Deviation 1.31

SECONDARY outcome

Timeframe: Days 2, 3, 4 and 5

Population: Safety Population.

Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Absolute Values for Body Temperature
Day 2
36.36 Degrees Celsius
Standard Deviation 0.303
Period 1: Absolute Values for Body Temperature
Day 3
36.26 Degrees Celsius
Standard Deviation 0.287
Period 1: Absolute Values for Body Temperature
Day 4
36.21 Degrees Celsius
Standard Deviation 0.361
Period 1: Absolute Values for Body Temperature
Day 5
36.43 Degrees Celsius
Standard Deviation 0.270

SECONDARY outcome

Timeframe: Days 2, 3, 4, 5, 6 and 7

Population: Safety Population.

Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Absolute Values for Body Temperature
Day 2
36.26 Degrees Celsius
Standard Deviation 0.339
Period 2: Absolute Values for Body Temperature
Day 3
36.15 Degrees Celsius
Standard Deviation 0.361
Period 2: Absolute Values for Body Temperature
Day 4
36.21 Degrees Celsius
Standard Deviation 0.318
Period 2: Absolute Values for Body Temperature
Day 5
36.35 Degrees Celsius
Standard Deviation 0.306
Period 2: Absolute Values for Body Temperature
Day 6
36.28 Degrees Celsius
Standard Deviation 0.309
Period 2: Absolute Values for Body Temperature
Day 7
36.28 Degrees Celsius
Standard Deviation 0.394

SECONDARY outcome

Timeframe: Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11

Population: Safety Population.

Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Absolute Values for Body Temperature
Day 2
36.33 Degrees Celsius
Standard Deviation 0.284
Period 3: Absolute Values for Body Temperature
Day 3
36.22 Degrees Celsius
Standard Deviation 0.369
Period 3: Absolute Values for Body Temperature
Day 4
36.42 Degrees Celsius
Standard Deviation 0.412
Period 3: Absolute Values for Body Temperature
Day 5
36.40 Degrees Celsius
Standard Deviation 0.405
Period 3: Absolute Values for Body Temperature
Day 6
36.37 Degrees Celsius
Standard Deviation 0.366
Period 3: Absolute Values for Body Temperature
Day 7
36.46 Degrees Celsius
Standard Deviation 0.371
Period 3: Absolute Values for Body Temperature
Day 8
36.28 Degrees Celsius
Standard Deviation 0.451
Period 3: Absolute Values for Body Temperature
Day 9
36.30 Degrees Celsius
Standard Deviation 0.337
Period 3: Absolute Values for Body Temperature
Day 10
36.37 Degrees Celsius
Standard Deviation 0.294
Period 3: Absolute Values for Body Temperature
Day 11
36.53 Degrees Celsius
Standard Deviation 0.307

SECONDARY outcome

Timeframe: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Population: Pharmacokinetic Parameter Population.

Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254 for GSK3640254 Arm
5.000 Hours
Interval 3.5 to 8.0

SECONDARY outcome

Timeframe: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Population: Pharmacokinetic Parameter Population.

Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Tmax of GSK3640254 for Dolutegravir + GSK3640254 Arm
5.000 Hours
Interval 3.5 to 8.0

SECONDARY outcome

Timeframe: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Population: Pharmacokinetic Parameter Population.

Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Data could not be determined due to limited sampling points after final dosing (during elimination phase). An accurate determination of GSK3640254 half-life would require sampling up to 3 times half-life (3 \* approximately 24 hours). However sampling in Period 2 was performed up to only 24 hours post-dose.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 2: Apparent Terminal Phase Half-life (T1/2) of GSK3640254 for GSK3640254 Arm
NA Hours
Geometric Coefficient of Variation NA
Data could not be determined due to limited sampling points after final dosing (during elimination phase). An accurate determination of GSK3640254 half-life would require sampling up to 3 times half-life (3 \* approximately 24 hours).

SECONDARY outcome

Timeframe: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Population: Pharmacokinetic Parameter Population.

Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: T1/2 of GSK3640254 for Dolutegravir + GSK3640254 Arm
23.417 Hours
Geometric Coefficient of Variation 15.0

SECONDARY outcome

Timeframe: Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Population: Pharmacokinetic Parameter Population.

Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: Tmax of Dolutegravir for Dolutegravir Arm
3.000 Hours
Interval 1.0 to 4.5

SECONDARY outcome

Timeframe: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Population: Pharmacokinetic Parameter Population.

Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: Tmax of Dolutegravir for Dolutegravir + GSK3640254 Arm
3.000 Hours
Interval 1.0 to 4.5

SECONDARY outcome

Timeframe: Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Population: Pharmacokinetic Parameter Population.

Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 1: T1/2 of Dolutegravir for Dolutegravir Arm
14.492 Hours
Geometric Coefficient of Variation 11.8

SECONDARY outcome

Timeframe: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Population: Pharmacokinetic Parameter Population.

Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure
Dolutegravir 50 mg
n=16 Participants
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7
Dolutegravir 50 mg + GSK3640254 200 mg
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Period 3: T1/2 of Dolutegravir for Dolutegravir + GSK3640254 Arm
14.690 Hours
Geometric Coefficient of Variation 12.1

Adverse Events

Dolutegravir 50 mg

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

GSK3640254 200 mg

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Dolutegravir 50 mg + GSK3640254 200 mg

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Dolutegravir 50 mg
n=16 participants at risk
In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
GSK3640254 200 mg
n=16 participants at risk
In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Dolutegravir 50 mg + GSK3640254 200 mg
n=16 participants at risk
In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Skin and subcutaneous tissue disorders
Dermatitis
0.00%
0/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
0.00%
0/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
6.2%
1/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders
Dermatitis contact
0.00%
0/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
0.00%
0/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
6.2%
1/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders
Keratosis pilaris
0.00%
0/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
6.2%
1/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
0.00%
0/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
General disorders
Medical device site dermatitis
0.00%
0/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
6.2%
1/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
6.2%
1/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
General disorders
Fatigue
0.00%
0/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
0.00%
0/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
6.2%
1/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
Ear and labyrinth disorders
Ear pruritus
0.00%
0/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
0.00%
0/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
6.2%
1/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications
Skin abrasion
6.2%
1/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
0.00%
0/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
0.00%
0/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
6.2%
1/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
0.00%
0/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
Psychiatric disorders
Anxiety
0.00%
0/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
6.2%
1/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
0.00%
0/16 • Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.

Additional Information

GSK Response Center

ViiV Healthcare

Phone: 866-435-7343

Results disclosure agreements

  • Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
  • Publication restrictions are in place

Restriction type: OTHER