Trial Outcomes & Findings for Dolutegravir Pediatric Liquid Formulation Study (NCT NCT03921723)

NCT ID: NCT03921723

Last Updated: 2020-07-31

Results Overview

Blood samples were collected at indicated time points and pharmacokinetic (PK) analysis was performed. PK parameters were determined by non-compartmental methods.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 22 participants
• Primary outcome timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose
• Results posted on: 2020-07-31

Participant Flow

This was a Phase 1, open-label, non-randomized, single dose study in healthy adult participants conducted at a single center in the United Kingdom (UK) to assess the prototype liquid fomulations of dolutegravir (DTG) versus DTG dispersible tablets (reference).

A total of 22 participants were enrolled in the study. The washout time between dosing in consecutive study periods was a minimum of 7 days.

Participant milestones

Measure	Prototype A/DTG Reference/Prototype B Participants were administered a single oral dose of 5 milligrams (mg) per milliliter (mL) DTG sodium oral suspension (Prototype A), for a total of 10 mg in Period 1 followed by a single oral dose of two 5 mg DTG dispersible tablets dispersed in water (DTG reference) in Period 2. Participants further received a single oral dose of 2 mg/mL DTG sodium oral liquid (Prototype B) in Period 3, also receiving a total dose of 10 mg. There was a minimum washout of 7 days between doses.
Period 1 (4 Days) STARTED	22
Period 1 (4 Days) COMPLETED	22
Period 1 (4 Days) NOT COMPLETED	0
Period 2 (4 Days) STARTED	22
Period 2 (4 Days) COMPLETED	19
Period 2 (4 Days) NOT COMPLETED	3
Period 3 (4 Days) STARTED	19
Period 3 (4 Days) COMPLETED	18
Period 3 (4 Days) NOT COMPLETED	1

Reasons for withdrawal

Measure	Prototype A/DTG Reference/Prototype B Participants were administered a single oral dose of 5 milligrams (mg) per milliliter (mL) DTG sodium oral suspension (Prototype A), for a total of 10 mg in Period 1 followed by a single oral dose of two 5 mg DTG dispersible tablets dispersed in water (DTG reference) in Period 2. Participants further received a single oral dose of 2 mg/mL DTG sodium oral liquid (Prototype B) in Period 3, also receiving a total dose of 10 mg. There was a minimum washout of 7 days between doses.
Period 2 (4 Days) Withdrawal by Subject	3
Period 3 (4 Days) Withdrawal by Subject	1

Baseline Characteristics

Dolutegravir Pediatric Liquid Formulation Study

Baseline characteristics by cohort

Measure	Prototype A/DTG Reference/Prototype B n=22 Participants Participants were administered a single oral dose of 5 milligrams (mg) per milliliter (mL) DTG sodium oral suspension (Prototype A), for a total of 10 mg in Period 1 followed by a single oral dose of two 5 mg DTG dispersible tablets dispersed in water (DTG reference) in Period 2. Participants further received a single oral dose of 2 mg/mL DTG sodium oral liquid (Prototype B) in Period 3, also receiving a total dose of 10 mg. There was a minimum washout of 7 days between doses.
Age, Continuous	31.3 Years STANDARD_DEVIATION 7.93 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Race/Ethnicity, Customized CENTRAL/SOUTH ASIAN HERITAGE	1 Participants n=5 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	2 Participants n=5 Participants
Race/Ethnicity, Customized WHITE/CAUCASIAN/EUROPEAN HERITAGE	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose

Population: PK Population comprised of participants in the 'All Participants' (who were randomized and received at least one dose of study medication)' population for whom a PK sample was obtained and had evaluable PK assay results. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points and pharmacokinetic (PK) analysis was performed. PK parameters were determined by non-compartmental methods.

Outcome measures

Measure	Prototype A n=18 Participants Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension)	Prototype B n=18 Participants Participants received a single oral dose of Prototype B (2 mg/mL DTG \[as DTG Sodium in glycerol vehicle\] oral liquid)	DTG Reference n=22 Participants Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water)
Area Under the Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Time Point (AUC[0-t]) for DTG	11.9968 Hours*micrograms per milliliter Geometric Coefficient of Variation 22.7	13.7921 Hours*micrograms per milliliter Geometric Coefficient of Variation 20.5	12.1944 Hours*micrograms per milliliter Geometric Coefficient of Variation 22.7

PRIMARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose

Population: PK Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods.

Outcome measures

Measure	Prototype A n=18 Participants Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension)	Prototype B n=18 Participants Participants received a single oral dose of Prototype B (2 mg/mL DTG \[as DTG Sodium in glycerol vehicle\] oral liquid)	DTG Reference n=22 Participants Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water)
AUC From Time Zero to Infinity (AUC[0-inf]) for DTG	12.8297 Hours*micrograms per milliliter Geometric Coefficient of Variation 23.0	14.8099 Hours*micrograms per milliliter Geometric Coefficient of Variation 21.8	13.0715 Hours*micrograms per milliliter Geometric Coefficient of Variation 23.8

PRIMARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose

Population: PK Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods.

Outcome measures

Measure	Prototype A n=18 Participants Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension)	Prototype B n=18 Participants Participants received a single oral dose of Prototype B (2 mg/mL DTG \[as DTG Sodium in glycerol vehicle\] oral liquid)	DTG Reference n=22 Participants Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water)
Maximum Observed Concentration (Cmax) for DTG	0.9200 Micrograms per milliliter Geometric Coefficient of Variation 14.4	0.9993 Micrograms per milliliter Geometric Coefficient of Variation 17.6	0.8200 Micrograms per milliliter Geometric Coefficient of Variation 26.1

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose

Population: PK Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods.

Outcome measures

Measure	Prototype A n=18 Participants Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension)	Prototype B n=18 Participants Participants received a single oral dose of Prototype B (2 mg/mL DTG \[as DTG Sodium in glycerol vehicle\] oral liquid)	DTG Reference n=22 Participants Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water)
Absorption Lag Time (Tlag) Following Administration of DTG	0.0 Hours Interval 0.0 to 0.0	0.0 Hours Interval 0.0 to 0.0	0.0 Hours Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose

Population: PK Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods.

Outcome measures

Measure	Prototype A n=18 Participants Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension)	Prototype B n=18 Participants Participants received a single oral dose of Prototype B (2 mg/mL DTG \[as DTG Sodium in glycerol vehicle\] oral liquid)	DTG Reference n=22 Participants Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water)
Time of Maximum Observed Concentration (Tmax) Following Administration of DTG	1.50 Hours Interval 0.5 to 3.5	0.50 Hours Interval 0.5 to 2.0	0.75 Hours Interval 0.5 to 5.0

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose

Population: PK Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods.

Outcome measures

Measure	Prototype A n=18 Participants Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension)	Prototype B n=18 Participants Participants received a single oral dose of Prototype B (2 mg/mL DTG \[as DTG Sodium in glycerol vehicle\] oral liquid)	DTG Reference n=22 Participants Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water)
Time of Last Quantifiable Concentration (Tlast) Following Administration of DTG	48.0000 Hours Interval 47.983 to 72.283	48.0333 Hours Interval 48.0 to 72.317	48.0000 Hours Interval 47.783 to 72.15

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose

Population: PK Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods.

Outcome measures

Measure	Prototype A n=18 Participants Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension)	Prototype B n=18 Participants Participants received a single oral dose of Prototype B (2 mg/mL DTG \[as DTG Sodium in glycerol vehicle\] oral liquid)	DTG Reference n=22 Participants Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water)
Elimination Half-life (t½) Following Administration of DTG	13.6389 Hours Geometric Coefficient of Variation 17.5	14.5997 Hours Geometric Coefficient of Variation 19.1	13.5807 Hours Geometric Coefficient of Variation 20.9

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose

Population: PK Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods.

Outcome measures

Measure	Prototype A n=18 Participants Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension)	Prototype B n=18 Participants Participants received a single oral dose of Prototype B (2 mg/mL DTG \[as DTG Sodium in glycerol vehicle\] oral liquid)	DTG Reference n=22 Participants Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water)
Apparent Elimination Rate Constant (Lambda z) Following Administration of DTG	0.0508 Per hour Geometric Coefficient of Variation 17.5	0.0475 Per hour Geometric Coefficient of Variation 19.1	0.0510 Per hour Geometric Coefficient of Variation 20.9

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose

Population: PK Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods.

Outcome measures

Measure	Prototype A n=18 Participants Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension)	Prototype B n=18 Participants Participants received a single oral dose of Prototype B (2 mg/mL DTG \[as DTG Sodium in glycerol vehicle\] oral liquid)	DTG Reference n=22 Participants Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water)
Percentage of AUC(0-inf) Extrapolated (%AUCex) Following Administration of DTG	6.1049 Percentage of AUCex Geometric Coefficient of Variation 36.8	5.8582 Percentage of AUCex Geometric Coefficient of Variation 57.1	6.3086 Percentage of AUCex Geometric Coefficient of Variation 36.3

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, and 24 hours post-dose

Population: PK Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods.

Outcome measures

Measure	Prototype A n=18 Participants Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension)	Prototype B n=18 Participants Participants received a single oral dose of Prototype B (2 mg/mL DTG \[as DTG Sodium in glycerol vehicle\] oral liquid)	DTG Reference n=22 Participants Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water)
AUC From Time Zero to 24 Hours (AUC[0-24]) Following Administration of DTG	9.2541 Hours*micrograms per milliliter Geometric Coefficient of Variation 16.4	10.2918 Hours*micrograms per milliliter Geometric Coefficient of Variation 15.8	9.2356 Hours*micrograms per milliliter Geometric Coefficient of Variation 18.7

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

Population: PK Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods.

Outcome measures

Measure	Prototype A n=18 Participants Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension)	Prototype B n=18 Participants Participants received a single oral dose of Prototype B (2 mg/mL DTG \[as DTG Sodium in glycerol vehicle\] oral liquid)	DTG Reference n=22 Participants Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water)
AUC From Time Zero to 72 Hours (AUC[0-72]) Following Administration of DTG	12.2645 Hours*micrograms per milliliter Geometric Coefficient of Variation 22.0	14.1062 Hours*micrograms per milliliter Geometric Coefficient of Variation 20.8	12.5289 Hours*micrograms per milliliter Geometric Coefficient of Variation 21.9

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

Population: PK Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods.

Outcome measures

Measure	Prototype A n=18 Participants Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension)	Prototype B n=18 Participants Participants received a single oral dose of Prototype B (2 mg/mL DTG \[as DTG Sodium in glycerol vehicle\] oral liquid)	DTG Reference n=22 Participants Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water)
Apparent Oral Clearance (CL/F) Following Administration of DTG	0.7794 Liters per hour Geometric Coefficient of Variation 23.0	0.6752 Liters per hour Geometric Coefficient of Variation 21.8	0.7650 Liters per hour Geometric Coefficient of Variation 23.8

SECONDARY outcome

Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

Population: PK Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods.

Outcome measures

Measure	Prototype A n=18 Participants Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension)	Prototype B n=18 Participants Participants received a single oral dose of Prototype B (2 mg/mL DTG \[as DTG Sodium in glycerol vehicle\] oral liquid)	DTG Reference n=22 Participants Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water)
Last Quantifiable Concentration (Ct) Following Administration of DTG	0.0398 Micrograms per milliliter Geometric Coefficient of Variation 35.4	0.0412 Micrograms per milliliter Geometric Coefficient of Variation 53.2	0.0421 Micrograms per milliliter Geometric Coefficient of Variation 39.9

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

Population: PK Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods.

Outcome measures

Measure	Prototype A n=18 Participants Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension)	Prototype B n=18 Participants Participants received a single oral dose of Prototype B (2 mg/mL DTG \[as DTG Sodium in glycerol vehicle\] oral liquid)	DTG Reference n=22 Participants Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water)
Apparent Oral Volume of Distribution (Vz/F) Following Administration of DTG	15.3369 Liters Geometric Coefficient of Variation 13.8	14.2222 Liters Geometric Coefficient of Variation 15.0	14.9889 Liters Geometric Coefficient of Variation 19.1

SECONDARY outcome

Timeframe: 24 hours

Population: PK Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods.

Outcome measures

Measure	Prototype A n=18 Participants Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension)	Prototype B n=18 Participants Participants received a single oral dose of Prototype B (2 mg/mL DTG \[as DTG Sodium in glycerol vehicle\] oral liquid)	DTG Reference n=22 Participants Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water)
Concentration at 24hours Post-dose (C24) Following Administration of DTG	0.1763 Micrograms per milliliter Geometric Coefficient of Variation 28.5	0.2167 Micrograms per milliliter Geometric Coefficient of Variation 21.7	0.1917 Micrograms per milliliter Geometric Coefficient of Variation 22.7

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 4

Population: Safety Population. All participants who were randomized and received at least one dose of study medication were part of Safety Population. Only those participants with data available at the specified data points were analyzed.

SBP and DBP was measured in a supine position after at least 5 minutes of rest for the participant in a quiet setting without any distractions using a completely automated device. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specific time point value.

Outcome measures

Measure	Prototype A n=18 Participants Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension)	Prototype B n=18 Participants Participants received a single oral dose of Prototype B (2 mg/mL DTG \[as DTG Sodium in glycerol vehicle\] oral liquid)	DTG Reference n=21 Participants Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water)
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Day 4	0.3 Millimeters of mercury Standard Deviation 10.50	4.9 Millimeters of mercury Standard Deviation 10.97	7.3 Millimeters of mercury Standard Deviation 9.59
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Day 4	-0.7 Millimeters of mercury Standard Deviation 6.83	1.8 Millimeters of mercury Standard Deviation 6.07	7.8 Millimeters of mercury Standard Deviation 7.05

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 4

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Pulse rate was measured in a supine position after at least 5 minutes of rest for the participant in a quiet setting without any distractions using a completely automated device. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specific time point value.

Outcome measures

Measure	Prototype A n=18 Participants Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension)	Prototype B n=18 Participants Participants received a single oral dose of Prototype B (2 mg/mL DTG \[as DTG Sodium in glycerol vehicle\] oral liquid)	DTG Reference n=21 Participants Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water)
Change From Baseline in Pulse Rate	6.1 Beats per minute Standard Deviation 11.06	6.8 Beats per minute Standard Deviation 8.54	4.1 Beats per minute Standard Deviation 11.38

SECONDARY outcome

Timeframe: Up to Week 11

Population: Safety Population.

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,is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgement.

Outcome measures

Measure	Prototype A n=18 Participants Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension)	Prototype B n=19 Participants Participants received a single oral dose of Prototype B (2 mg/mL DTG \[as DTG Sodium in glycerol vehicle\] oral liquid)	DTG Reference n=22 Participants Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water)
Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) Non-serious AEs	3 Participants	3 Participants	4 Participants
Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day -1)

Population: Safety Population.

Blood samples were collected to analyze the following hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, hemoglobin, hematocrit, mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), percentage reticulocytes and red blood cell count. Data for clinically significant abnormal hematology parameters have been presented. Clinically significant abnormal laboratory findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Outcome measures

Measure	Prototype A n=18 Participants Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension)	Prototype B n=19 Participants Participants received a single oral dose of Prototype B (2 mg/mL DTG \[as DTG Sodium in glycerol vehicle\] oral liquid)	DTG Reference n=22 Participants Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water)
Number of Participants With Clinically Significant Hematology Parameters	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day -1)

Population: Safety Population.

Blood samples were collected to analyze the following clinical chemistry parameters: Potassium, calcium, sodium, creatinine, glucose, alkaline phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Blood urea nitrogen (BUN), total and direct bilirubin, total protein and creatine kinase. Data for clinically significant abnormal clinical chemistry parameters have been presented. Clinically significant abnormal laboratory findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Outcome measures

Measure	Prototype A n=18 Participants Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension)	Prototype B n=19 Participants Participants received a single oral dose of Prototype B (2 mg/mL DTG \[as DTG Sodium in glycerol vehicle\] oral liquid)	DTG Reference n=22 Participants Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water)
Number of Participants With Clinically Significant Chemistry Parameters	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day -1)

Population: Safety Population.

Urine samples were collected to analyze the following urinalysis parameters: specific gravity, potential of hydrogen (pH). Clinically significant abnormal laboratory findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Outcome measures

Measure	Prototype A n=18 Participants Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension)	Prototype B n=19 Participants Participants received a single oral dose of Prototype B (2 mg/mL DTG \[as DTG Sodium in glycerol vehicle\] oral liquid)	DTG Reference n=22 Participants Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water)
Number of Participants With Clinically Significant Urine Parameters	0 Participants	0 Participants	0 Participants

Adverse Events

Prototype A

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Prototype B

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

DTG Reference

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Prototype A n=18 participants at risk Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension)	Prototype B n=19 participants at risk Participants received a single oral dose of Prototype B (2 mg/mL DTG \[as DTG Sodium in glycerol vehicle\] oral liquid)	DTG Reference n=22 participants at risk Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water)
Nervous system disorders Headache	0.00% 0/18 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population	5.3% 1/19 • Number of events 1 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population	9.1% 2/22 • Number of events 2 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population
Nervous system disorders Tension headache	5.6% 1/18 • Number of events 1 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population	0.00% 0/19 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population	0.00% 0/22 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population
Gastrointestinal disorders Diarrhoea	5.6% 1/18 • Number of events 1 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population	0.00% 0/19 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population	0.00% 0/22 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population
Infections and infestations Hordeolum	0.00% 0/18 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population	0.00% 0/19 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population	4.5% 1/22 • Number of events 1 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/18 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population	5.3% 1/19 • Number of events 1 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population	0.00% 0/22 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/18 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population	5.3% 1/19 • Number of events 1 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population	0.00% 0/22 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population
Respiratory, thoracic and mediastinal disorders Epistaxis	5.6% 1/18 • Number of events 1 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population	0.00% 0/19 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population	0.00% 0/22 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/18 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population	5.3% 1/19 • Number of events 1 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population	0.00% 0/22 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/18 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population	0.00% 0/19 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population	4.5% 1/22 • Number of events 1 • Non-serious and serious adverse events were collected up to Week 11 Non-serious AEs and SAEs were collected in the Safety Population

Additional Information

GSK Response Center

ViiV Healthcare

Phone: 866-435-7343

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