Trial Outcomes & Findings for Study to Evaluate Pharmacokinetics, Safety and Tolerability of Dolutegravir and Rilpivirine (JULUCA™) 50 Milligram (mg)/25 mg Tablets in Healthy Subjects of Japanese Descent (NCT NCT03984838)

NCT ID: NCT03984838

Last Updated: 2020-07-14

Results Overview

Blood samples were collected at indicated time-points for analysis of AUC (0-infinity) of DTG. PK parameters were calculated by standard non-compartmental analysis.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 16 participants
• Primary outcome timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose
• Results posted on: 2020-07-14

Participant Flow

The was a single dose, open-label study in healthy Japanese participants for the evaluation of pharmacokinetics (PK), safety and tolerability of fixed dose combination (FDC) tablet of Dolutegravir (DTG)/Rilpivirine (RPV) 50 milligrams (mg)/ 25 mg

A total of 16 participants were enrolled in the study

Participant milestones

Measure	DTG/RPV 50mg/25mg FDC Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate Pharmacokinetics, Safety and Tolerability of Dolutegravir and Rilpivirine (JULUCA™) 50 Milligram (mg)/25 mg Tablets in Healthy Subjects of Japanese Descent

Baseline characteristics by cohort

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Age, Continuous	41.6 Years STANDARD_DEVIATION 9.69 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race/Ethnicity, Customized Japanese Heritage/East Asian	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose

Population: PK Population included all participants in the Safety Population (participants who were enrolled in the study and received at least one dose of study drug) for whom a PK sample was obtained and had evaluable PK assay results.

Blood samples were collected at indicated time-points for analysis of AUC (0-infinity) of DTG. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Area Under the Concentration (AUC) Time Curve From Time Zero Extrapolated to Infinite Time (AUC [0-infinity]) of DTG	90.9402 Hours*micrograms per milliliter Geometric Coefficient of Variation 26.2

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of AUC (0-infinity) of RPV. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
AUC (0-infinity) of RPV	4027.9415 Hours*nanogram per milliliter Geometric Coefficient of Variation 29.0

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of AUC (0-t) of DTG. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Area Under the Concentration Time Curve From Time Zero to Last Time of Quantifiable Concentration (AUC [0-t]) of DTG	89.1993 Hours*micrograms per milliliter Geometric Coefficient of Variation 26.8

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of AUC (0-t) of RPV. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
AUC (0-t) of RPV	3920.9404 Hours*nanogram per milliliter Geometric Coefficient of Variation 29.1

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of Cmax of DTG. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Maximum Observed Plasma Concentration (Cmax) of DTG	4108.5 Nanograms per milliliter Geometric Coefficient of Variation 15.0

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of Cmax of RPV. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Cmax of RPV	136.10 Nanogram per milliliter Geometric Coefficient of Variation 34.3

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of tlag of DTG. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Absorption Lag Time (Tlag) of DTG	0.0 Hours Interval 0.0 to 1.0

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of tlag of RPV. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Tlag of RPV	0.5 Hours Interval 0.0 to 2.0

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of tmax of DTG. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Time to Reach Maximum Observed Concentration (Tmax) of DTG	3.0085 Hours Interval 1.002 to 5.003

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of tmax of RPV. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Tmax of RPV	4.4976 Hours Interval 3.503 to 5.999

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of tlast of DTG. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Time of Last Quantifiable Concentration (Tlast) of DTG	120.0854 Hours Interval 71.818 to 145.015

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of tlast of RPV. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Tlast of RPV	214.5819 Hours Interval 120.57 to 265.502

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of t1/2 of DTG. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Elimination Half-life (t1/2) of DTG	17.3135 Hours Geometric Coefficient of Variation 15.6

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of t1/2 of RPV. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
T1/2 of RPV	37.2571 Hours Geometric Coefficient of Variation 33.7

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of lambda z of DTG. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Apparent Elimination Rate Constant (Lambda z) of DTG	0.0405 Per hour Standard Deviation 0.00604

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of lambda z of RPV. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Lambda z of RPV	0.0196 Per hour Standard Deviation 0.00674

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of percentage AUCex of DTG. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Percentage of AUC(0-infinity) That Was Extrapolated (%AUCex) of DTG	1.9065 Percentage of AUCex Standard Deviation 1.28407

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of percentage AUCex of RPV. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Percentage AUCex of RPV	2.6501 Percentage of AUCex Standard Deviation 1.14962

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, and 24 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of AUC(0-24) of DTG. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Area Under the Plasma Concentration Time Curve From Time Zero to 24 Hours (AUC[0-24]) of DTG	54.9466 Hours*micrograms per milliliter Geometric Coefficient of Variation 20.4

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, and 24 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of AUC (0-24) of RPV. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
AUC (0-24) of RPV	1420.2525 Hours*nanograms per milliliter Geometric Coefficient of Variation 24.8

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, and 72 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of AUC(0-72) of DTG. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Area Under the Plasma Concentration Time Curve From Time Zero to 72 Hours (AUC[0-72]) of DTG	85.3534 Hours*micrograms per milliliter Geometric Coefficient of Variation 24.3

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48 and 72 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of AUC (0-72) of RPV. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
AUC (0-72) of RPV	2886.6035 Hours*nanograms per milliliter Geometric Coefficient of Variation 22.7

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of CL/F of DTG. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Apparent Oral Clearance (CL/F) of DTG	0.5498 Liters per hour Geometric Coefficient of Variation 26.2

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, 264 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of CL/F of RPV. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
CL/F of RPV	6.2066 Liters per hour Geometric Coefficient of Variation 29.0

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of Vz/F of DTG. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Apparent Oral Volume of Distribution (Vz/F) of DTG	14.0079 Liters Standard Deviation 2.81380

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of Vz/F of RPV. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Vz/F of RPV	347.3276 Liters Standard Deviation 99.96058

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of Ct of DTG. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Last Quantifiable Concentration (Ct) of DTG	54.59 Nanograms per milliliter Geometric Coefficient of Variation 82.1

PRIMARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of Ct of RPV. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Ct of RPV	1.836 Nanograms per milliliter Geometric Coefficient of Variation 30.4

PRIMARY outcome

Timeframe: At 24 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of C24 of DTG. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Concentration at 24-hour Post-dose (C24) of DTG	1453.6 Nanograms per milliliter Geometric Coefficient of Variation 25.6

PRIMARY outcome

Timeframe: At 24 hours post-dose

Population: PK Population

Blood samples were collected at indicated time-points for analysis of C24 of RPV. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
C24 of RPV	43.35 Nanograms per milliliter Geometric Coefficient of Variation 22.1

SECONDARY outcome

Timeframe: Up to Day 18

Population: Safety Population included participants who were enrolled in the study and received at least one dose of study drug.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose: results in death and is life-threatening; which requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly, or any other situation that require medical or scientific judgment.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) AE	2 Participants
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) SAE	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 3

Population: Safety Population

Blood samples were collected at indicated time-points for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, leukocyte, monocytes, eosinophils and basophils. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Change From Baseline in Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count Basophils	-0.03 Giga cells per liter Standard Deviation 0.045
Change From Baseline in Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count Eosinophils	-0.04 Giga cells per liter Standard Deviation 0.089
Change From Baseline in Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count Leukocytes	-0.16 Giga cells per liter Standard Deviation 1.016
Change From Baseline in Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count Lymphocytes	-0.03 Giga cells per liter Standard Deviation 0.445
Change From Baseline in Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count Monocytes	-0.04 Giga cells per liter Standard Deviation 0.081
Change From Baseline in Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count Platelets	5.4 Giga cells per liter Standard Deviation 18.85
Change From Baseline in Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count Neutrophils	-0.06 Giga cells per liter Standard Deviation 0.788

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 3

Population: Safety Population

Blood samples were collected at indicated time-points for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, leukocyte, eosinophils and basophils. Baseline was defined as Day -1.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count Basophils, Baseline (Day -1)	0.04 Giga cells per liter Standard Deviation 0.050
Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count Basophils, Day 3	0.01 Giga cells per liter Standard Deviation 0.034
Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count Eosinophils, Baseline (Day -1)	0.20 Giga cells per liter Standard Deviation 0.110
Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count Eosinophils, Day 3	0.16 Giga cells per liter Standard Deviation 0.063
Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count Leukocytes, Baseline (Day -1)	5.76 Giga cells per liter Standard Deviation 1.238
Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count Leukocytes, Day 3	5.59 Giga cells per liter Standard Deviation 1.433
Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count Lymphocytes, Baseline (Day -1)	1.84 Giga cells per liter Standard Deviation 0.407
Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count Lymphocytes, Day 3	1.82 Giga cells per liter Standard Deviation 0.565
Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count Monocytes, Baseline (Day -1)	0.45 Giga cells per liter Standard Deviation 0.126
Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count Monocytes, Day 3	0.41 Giga cells per liter Standard Deviation 0.141
Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count Platelets, Baseline (Day -1)	233.3 Giga cells per liter Standard Deviation 43.24
Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count Platelets, Day 3	238.6 Giga cells per liter Standard Deviation 47.88
Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count Neutrophils, Baseline (Day -1)	3.21 Giga cells per liter Standard Deviation 0.973
Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count Neutrophils, Day 3	3.16 Giga cells per liter Standard Deviation 1.001

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 3

Population: Safety Population

Blood samples were collected at indicated timepoints for analysis of hematology parameter like hemoglobin. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Change From Baseline in Hemoglobin Level	10.1 Grams per liter Standard Deviation 7.33

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 3

Population: Safety Population

Blood samples were collected at indicated timepoints for analysis of hematology parameter like hemoglobin. Baseline was defined as Day -1.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Absolute Values of Hemoglobin Level Baseline (Day -1)	140.9 Grams per liter Standard Deviation 15.92
Absolute Values of Hemoglobin Level Day 3	151.0 Grams per liter Standard Deviation 15.19

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 3

Population: Safety Population

Blood samples were collected at indicated timepoints for analysis of hematology parameter like hematocrit. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Change From Baseline in Hematocrit Level	0.0308 Proportion of red blood cells in blood Standard Deviation 0.01967

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 3

Population: Safety Population

Blood samples were collected at indicated timepoints for analysis of hematology parameter like hematocrit. Baseline was defined as Day -1.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Absolute Values of Hematocrit Level Baseline (Day -1)	0.4248 Proportion of red blood cells in blood Standard Deviation 0.04060
Absolute Values of Hematocrit Level Day 3	0.4556 Proportion of red blood cells in blood Standard Deviation 0.04087

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 3

Population: Safety Population

Blood samples were collected at indicated timepoints for analysis of hematology parameter like erythrocytes. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Change From Baseline in Erythrocytes	0.358 Trillion cells per liter Standard Deviation 0.2112

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 3

Population: Safety Population

Blood samples were collected at indicated timepoints for analysis of hematology parameter like erythrocytes. Baseline was defined as Day -1.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Absolute Values of Erythrocytes Baseline (Day -1)	4.688 Trillion cells per liter Standard Deviation 0.5299
Absolute Values of Erythrocytes Day 3	5.046 Trillion cells per liter Standard Deviation 0.4994

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 3

Population: Safety Population

Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCH. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Change From Baseline in Mean Corpuscular Hemoglobin (MCH)	-0.10 Picograms Standard Deviation 0.303

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 3

Population: Safety Population

Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCH. Baseline was defined as Day -1.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Absolute Values of MCH Baseline (Day -1)	30.04 Picograms Standard Deviation 1.288
Absolute Values of MCH Day 3	29.94 Picograms Standard Deviation 1.275

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 3

Population: Safety Population

Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCV. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Change From Baseline in Mean Corpuscular Volume (MCV)	-0.43 Femtoliters Standard Deviation 0.849

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 3

Population: Safety Population

Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCV. Baseline was defined as Day -1.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Absolute Values of MCV Baseline (Day -1)	90.87 Femtoliters Standard Deviation 3.593
Absolute Values of MCV Day 3	90.44 Femtoliters Standard Deviation 3.522

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 3

Population: Safety Population

Blood samples were collected at indicated timepoints for analysis of hematology parameter like reticulocytes. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Change From Baseline in Reticulocytes	0.13 Percentage of reticulocytes Standard Deviation 0.211

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 3

Population: Safety Population

Blood samples were collected at indicated timepoints for analysis of hematology parameter like reticulocytes. Baseline was defined as Day -1.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Absolute Values of Reticulocytes Baseline (Day -1)	1.47 Percentage of reticulocytes Standard Deviation 0.460
Absolute Values of Reticulocytes Day 3	1.59 Percentage of reticulocytes Standard Deviation 0.491

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 3

Population: Safety Population

Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters like (BUN), glucose, sodium, calcium, and potassium levels. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Sodium, and Potassium Levels Calcium	0.0483 Millimoles per Liter Standard Deviation 0.07315
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Sodium, and Potassium Levels Glucose	-0.1908 Millimoles per Liter Standard Deviation 0.30738
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Sodium, and Potassium Levels Potassium	0.02 Millimoles per Liter Standard Deviation 0.288
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Sodium, and Potassium Levels Sodium	2.8 Millimoles per Liter Standard Deviation 2.46
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Sodium, and Potassium Levels BUN	0.2901 Millimoles per Liter Standard Deviation 0.94200

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 3

Population: Safety Population

Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters like (BUN), glucose, sodium, calcium, and potassium levels. Baseline was defined as Day -1.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Absolute Values of BUN, Glucose, Calcium, Sodium, and Potassium Levels Calcium, Baseline (Day -1)	2.3079 Millimoles per Liter Standard Deviation 0.08098
Absolute Values of BUN, Glucose, Calcium, Sodium, and Potassium Levels Calcium, Day 3	2.3562 Millimoles per Liter Standard Deviation 0.06440
Absolute Values of BUN, Glucose, Calcium, Sodium, and Potassium Levels Glucose, Baseline (Day -1)	5.5163 Millimoles per Liter Standard Deviation 0.40684
Absolute Values of BUN, Glucose, Calcium, Sodium, and Potassium Levels Glucose, Day 3	5.3255 Millimoles per Liter Standard Deviation 0.39014
Absolute Values of BUN, Glucose, Calcium, Sodium, and Potassium Levels Potassium, Baseline (Day -1)	4.18 Millimoles per Liter Standard Deviation 0.284
Absolute Values of BUN, Glucose, Calcium, Sodium, and Potassium Levels Potassium, Day 3	4.19 Millimoles per Liter Standard Deviation 0.124
Absolute Values of BUN, Glucose, Calcium, Sodium, and Potassium Levels Sodium, Baseline (Day -1)	137.1 Millimoles per Liter Standard Deviation 1.88
Absolute Values of BUN, Glucose, Calcium, Sodium, and Potassium Levels Sodium, Day 3	139.8 Millimoles per Liter Standard Deviation 2.37
Absolute Values of BUN, Glucose, Calcium, Sodium, and Potassium Levels BUN, Baseline (Day -1)	4.1948 Millimoles per Liter Standard Deviation 1.01395
Absolute Values of BUN, Glucose, Calcium, Sodium, and Potassium Levels BUN, Day 3	4.4848 Millimoles per Liter Standard Deviation 0.99251

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 3

Population: Safety Population

Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters like total and direct bilirubin, creatinine and protein levels. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Change From Baseline in Total and Direct Bilirubin, Creatinine and Protein Levels Total bilirubin	3.954 Micromoles per liter Standard Deviation 4.6188
Change From Baseline in Total and Direct Bilirubin, Creatinine and Protein Levels Direct bilirubin	0.428 Micromoles per liter Standard Deviation 0.7647
Change From Baseline in Total and Direct Bilirubin, Creatinine and Protein Levels Creatinine	2.7072 Micromoles per liter Standard Deviation 6.15397
Change From Baseline in Total and Direct Bilirubin, Creatinine and Protein Levels Protein	4.2 Micromoles per liter Standard Deviation 3.73

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 3

Population: Safety Population

Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters like total and direct bilirubin, creatinine and protein levels. Baseline was defined as Day -1.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Absolute Values of Total and Direct Bilirubin, Creatinine and Protein Levels Total bilirubin, Baseline (Day -1)	11.008 Micromoles per liter Standard Deviation 4.3694
Absolute Values of Total and Direct Bilirubin, Creatinine and Protein Levels Total bilirubin, Day 3	14.963 Micromoles per liter Standard Deviation 5.2054
Absolute Values of Total and Direct Bilirubin, Creatinine and Protein Levels Direct bilirubin, Baseline (Day -1)	2.565 Micromoles per liter Standard Deviation 1.2488
Absolute Values of Total and Direct Bilirubin, Creatinine and Protein Levels Direct bilirubin, Day 3	2.993 Micromoles per liter Standard Deviation 1.1682
Absolute Values of Total and Direct Bilirubin, Creatinine and Protein Levels Creatinine, Baseline (Day -1)	80.3335 Micromoles per liter Standard Deviation 13.88330
Absolute Values of Total and Direct Bilirubin, Creatinine and Protein Levels Creatinine, Day 3	83.0408 Micromoles per liter Standard Deviation 13.20870
Absolute Values of Total and Direct Bilirubin, Creatinine and Protein Levels Protein, Baseline (Day -1)	66.6 Micromoles per liter Standard Deviation 3.63
Absolute Values of Total and Direct Bilirubin, Creatinine and Protein Levels Protein, Day 3	70.8 Micromoles per liter Standard Deviation 4.57

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 3

Population: Safety Population

Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters like AST, ALT and ALP levels. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels ALT	3.2 International units per Liter Standard Deviation 7.46
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels AST	0.6 International units per Liter Standard Deviation 3.42
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels ALP	0.9 International units per Liter Standard Deviation 2.87

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 3

Population: Safety Population

Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters like AST, ALT and ALP levels. Baseline was defined as Day -1.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Absolute Values of AST, ALT and ALP Levels ALT, Baseline (Day -1)	19.4 International units per Liter Standard Deviation 7.20
Absolute Values of AST, ALT and ALP Levels ALT, Day 3	22.6 International units per Liter Standard Deviation 11.51
Absolute Values of AST, ALT and ALP Levels AST, Baseline (Day -1)	17.9 International units per Liter Standard Deviation 3.72
Absolute Values of AST, ALT and ALP Levels AST, Day 3	18.5 International units per Liter Standard Deviation 4.41
Absolute Values of AST, ALT and ALP Levels ALP, Baseline (Day -1)	52.3 International units per Liter Standard Deviation 11.57
Absolute Values of AST, ALT and ALP Levels ALP, Day 3	53.1 International units per Liter Standard Deviation 11.24

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 12

Population: Safety Population

SBP and DBP were assessed in the supine position with a completely automated device. Day 1 (Pre-dose) was defined as Baseline. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP	6.2 Millimeters of mercury Standard Deviation 9.35
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP	1.6 Millimeters of mercury Standard Deviation 9.61

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 12

Population: Safety Population

SBP and DBP were assessed in the supine position with a completely automated device. Day 1 (Pre-dose) was defined as Baseline.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Absolute Values of SBP and DBP DBP, Day 12	71.7 Millimeters of mercury Standard Deviation 11.29
Absolute Values of SBP and DBP SBP, Day 1, Pre-dose	107.0 Millimeters of mercury Standard Deviation 7.43
Absolute Values of SBP and DBP SBP, Day 12	113.2 Millimeters of mercury Standard Deviation 10.89
Absolute Values of SBP and DBP DBP, Day 1, Pre-dose	70.1 Millimeters of mercury Standard Deviation 7.58

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 12

Population: Safety Population

Pulse rate was assessed in the supine position with a completely automated device. Day 1 (Pre-dose) was defined as Baseline. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Change From Baseline in Pulse Rate	8.7 Beats per minute Standard Deviation 10.32

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 12

Population: Safety Population

Pulse rate was assessed in the supine position with a completely automated device. Day 1 (Pre-dose) was defined as Baseline.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Absolute Values of Pulse Rate Day 1, Pre-dose	58.0 Beats per minute Standard Deviation 9.87
Absolute Values of Pulse Rate Day 12	66.7 Beats per minute Standard Deviation 10.00

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 12

Population: Safety Population

Body temperature were assessed at indicated time-points. Day 1 (Pre-dose) was defined as Baseline. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Change From Baseline in Body Temperature	0.06 Degree Celsius Standard Deviation 0.453

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 12

Population: Safety Population

Body temperature were assessed at indicated time-points. Day 1 (Pre-dose) was defined as Baseline.

Outcome measures

Measure	DTG/RPV 50mg/25mg FDC n=16 Participants Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Absolute Values of Body Temperature Day 1, Pre-dose	36.16 Degree Celsius Standard Deviation 0.271
Absolute Values of Body Temperature Day 12	36.21 Degree Celsius Standard Deviation 0.443

Adverse Events

DTG/RPV 50mg/25mg FDC

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	DTG/RPV 50mg/25mg FDC n=16 participants at risk Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state
Gastrointestinal disorders Vomiting	6.2% 1/16 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 18 Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who were enrolled in the study and received at least one dose of study drug.
General disorders Vessel puncture site bruise	6.2% 1/16 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 18 Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who were enrolled in the study and received at least one dose of study drug.
Nervous system disorders Headache	6.2% 1/16 • Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 18 Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who were enrolled in the study and received at least one dose of study drug.

Additional Information

GSK Response Center

ViiV Healthcare

Phone: 8664357343

Email: GSKClinicalSupportHD@gsk.com

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