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.
COMPLETED
PHASE1
16 participants
Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose
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
| 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
| 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-dosePopulation: 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
| 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-dosePopulation: 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
| 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-dosePopulation: 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
| 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-dosePopulation: 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
| 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-dosePopulation: 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
| 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-dosePopulation: 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
| 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-dosePopulation: 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
| 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-dosePopulation: 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
| 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-dosePopulation: 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
| 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-dosePopulation: 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
| 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-dosePopulation: 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
| 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-dosePopulation: 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
| 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 27Population: 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
| 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 9Population: 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
| 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 7Population: 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
| 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 10Population: 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
| 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 9Population: 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
| 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 7Population: 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
| 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 10Population: 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
| 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 9Population: 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
| 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 7Population: 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
| 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 10Population: 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
| 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 9Population: 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
| 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 7Population: 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
| 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 10Population: 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
| 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 9Population: 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
| 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 7Population: 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
| 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 10Population: 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
| 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 9Population: 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
| 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 7Population: 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
| 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 10Population: 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
| 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 9Population: 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
| 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 7Population: 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
| 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 10Population: 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
| 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 9Population: 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
| 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 7Population: 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
| 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 10Population: 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
| 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 9Population: 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
| 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 7Population: 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
| 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 10Population: 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
| 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 9Population: 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
| 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 7Population: 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
| 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 10Population: 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
| 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 9Population: 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
| 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 7Population: 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
| 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 10Population: 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
| 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 9Population: 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
| 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 7Population: 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
| 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 10Population: 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
| 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 9Population: 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
| 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 7Population: 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
| 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 10Population: 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
| 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 9Population: 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
| 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 7Population: 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
| 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 10Population: 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
| 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 9Population: 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
| 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 7Population: 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
| 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 10Population: 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
| 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 hoursPopulation: 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
| 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 hoursPopulation: 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
| 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 10Population: 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
| 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 5Population: 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
| 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 7Population: 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
| 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 11Population: 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
| 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 5Population: 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
| 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 7Population: 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
| 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 11Population: 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
| 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 5Population: 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
| 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 7Population: 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
| 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 11Population: 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
| 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 5Population: 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
| 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 7Population: 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
| 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 11Population: 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
| 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 9Population: Safety Population.
Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count.
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 7Population: Safety Population.
Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count.
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 10Population: 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
| 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 9Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: hemoglobin.
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 7Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: hemoglobin.
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 10Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: hemoglobin.
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 9Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: hematocrit.
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 7Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: hematocrit.
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 10Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: hematocrit.
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 9Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: erythrocytes.
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 7Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: erythrocytes.
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 10Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: erythrocytes.
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 9Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.
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 7Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.
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 10Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.
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 9Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.
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 7Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.
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 10Population: Safety Population.
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.
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 9Population: 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
| 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 7Population: 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
| 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 10Population: 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
| 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 9Population: Safety Population.
Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase.
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 7Population: Safety Population.
Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase.
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 10Population: Safety Population.
Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase.
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 9Population: Safety Population.
Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin.
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 7Population: Safety Population.
Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin.
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 10Population: Safety Population.
Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin.
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 9Population: Safety Population.
Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein.
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 7Population: Safety Population.
Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein.
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 10Population: Safety Population.
Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein.
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 9Population: Safety Population.
Blood samples were collected to analyze the chemistry parameters: amylase and lipase.
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 7Population: Safety Population.
Blood samples were collected to analyze the chemistry parameters: amylase and lipase.
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 10Population: Safety Population.
Blood samples were collected to analyze the chemistry parameters: amylase and lipase.
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 9Population: 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
| 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 7Population: 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
| 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 10Population: 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
| 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 9Population: Safety Population.
Urine samples were collected to analyze the urinalysis parameter: urobilinogen.
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 7Population: Safety Population.
Urine samples were collected to analyze the urinalysis parameter: urobilinogen.
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 10Population: Safety Population.
Urine samples were collected to analyze the urinalysis parameter: urobilinogen.
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 9Population: 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
| 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 7Population: 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
| 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 10Population: 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
| 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 hoursPopulation: 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
| 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 hoursPopulation: 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
| 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 10Population: 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
| 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 5Population: Safety Population.
SBP and DBP were measured in the semi-recumbent position with a completely automated device.
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 7Population: Safety Population.
SBP and DBP were measured in the semi-recumbent position with a completely automated device.
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 11Population: Safety Population.
SBP and DBP were measured in the semi-recumbent position with a completely automated device.
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 5Population: Safety Population.
Pulse rate was measured in the semi-recumbent position with a completely automated device.
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 7Population: Safety Population.
Pulse rate was measured in the semi-recumbent position with a completely automated device.
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 11Population: Safety Population.
Pulse rate was measured in the semi-recumbent position with a completely automated device.
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 5Population: 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
| 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 7Population: 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
| 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 11Population: 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
| 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 5Population: 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
| 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 7Population: 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
| 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 11Population: 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
| 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-dosePopulation: 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
| 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-dosePopulation: 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
| 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-dosePopulation: 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
| 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-dosePopulation: 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
| 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-dosePopulation: 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
| 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-dosePopulation: 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
| 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-dosePopulation: 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
| 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-dosePopulation: 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
| 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
GSK3640254 200 mg
Dolutegravir 50 mg + GSK3640254 200 mg
Serious adverse events
Adverse event data not reported
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
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