HIV Infections
Conditions
Keywords
Pediatric dispersible tablets, Bioavailability
Brief summary
This is a 2-part, single-dose, open label, randomized 3-way cross-over study to compare BA of pediatric study drugs TRIUMEQ and (DTG/3TC) in healthy volunteers under fasted conditions. Study will be conducted in 2-parts. Each part 1 and part 2 will comprise of 3-treatment periods (TP) where Part 1, will assess BA, of pediatric TRIUMEQ dispersible tablets with an adult TRIUMEQ conventional tablet formulation and Part 2, will assess BA, of pediatric DTG/3TC dispersible tablets with adult DTG and 3TC conventional tablets formulation. Total duration of study is 9-weeks and will be conducted in approximately 36 subjects. The 2-parts, may be run in parallel as they are independent of each other. TRIUMEQ is a registered trademark of GlaxoSmithKline group of companies.
Interventions
DRUGTreatment A
TRIUMEQ (Adult) administered as a, single dose, fixed dose combination (FDC) tablet - DTG 50 mg/ABC 600 mg/3TC 300 mg as 1 conventional tablet, orally as direct-to-mouth.
DRUGTreatment B
TRIUMEQ (Pediatric) administered as a, single dose, FDC tablet - DTG 5 mg/ABC 60 mg/ 3TC 30 mg, orally as 10 dispersible tablets
DRUGTreatment C
TRIUMEQ (Pediatric) administered as a, single dose, FDC tablet - DTG 5 mg/ABC 60 mg/3TC 30 mg, orally as direct-to-mouth.
DRUGTreatment D
DTG and 3TC (Adult), administered as a, single dose, Single dose, 1 tablet DTG (50 mg) and 1 tablet 3TC (300 mg), orally as direct-to-mouth.
DRUGTreatment E
DTG and 3TC (Pediatric) administered as a, single dose, FDC tablet single dose, FDC tablet - DTG 5 mg/3TC 30 mg, orally as 10 dispersible tablets.
DRUGTreatment F
DTG and 3TC (Pediatric) administered as a, single dose, FDC tablet single dose, FDC tablet - DTG 5 mg/3TC 30 mg, orally as direct-to-mouth.
Sponsors
ViiV Healthcare
GlaxoSmithKline
Pharmaceutical Product Development (PPD), Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study in healthy volunteers.
Intervention model description
2-part study with 3-TPs each. Part 1, compares relative BA of TRIUMEQ dispersible tablets for pediatric populations (DTG, 5 milligram \[mg\]/abacavir \[ABC\] 60 mg/3TC 30 mg), when administered as direct-to-mouth and when dispersed into purified water, with adult TRIUMEQ conventional tablet (DTG 50 mg/ABC 600 mg/3TC 300 mg), administered as direct-to-mouth (reference). Additionally, part 2 will compare relative BA of DTG/3TC (DTG 5 mg/3TC 30 mg), dispersible tablets for pediatric populations, when administered as direct-to mouth and when dispersed into purified water, with adult DTG (50 mg) and 3TC (300 mg) conventional tablets, when administered as direct-to-mouth (reference). Each TP, in Part 1 and 2 will have, wash-out period of 7-days (with minus 4 hours) between each single dose, for flexible dosing. During TPs, subjects will be admitted, to clinic on Day-1, following completion of last study procedure on Day 4, post which follow-up visit conducted, 7 to 10 days after last dose.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Between 18 and 65 years of age, inclusive, at the time of signing the informed consent. * Healthy subjects as determined by the investigator or medically qualified designee based on a medical evaluation, including medical history, physical examination, laboratory tests, and cardiac evaluation (history and ECG). * Body weight \>=50 kilogram (kg) for males and \>=45 kg for females and body mass index (BMI) within the range 18.5 - 31.0 kilogram per square meter (kg/m\^2) (inclusive). * Male and female subjects where the male subjects must agree to use contraception during the TP and for at least 2 weeks plus an additional 90 days (a spermatogenesis cycle) after the last dose of study treatment and refrain from donating sperm during this period. For the female subjects, female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin \[hCG\] test), not lactating, and at least 1 of the following conditions applies: Female with non-reproductive potential, defined as Premenopausal females with one of the following like documented tubal ligation, documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, documented hysterectomy, documented bilateral oophorectomy, the Postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone and estradiol levels consistent with menopause. Females on hormone replacement therapy (HRT), and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment; Females with reproductive potential and agrees to follow one of the options for avoiding pregnancy in females of reproductive potential, from 30 days prior to the first dose of study medication and until 2 weeks after dosing with study medication and completion of the follow-up visit; the investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception; All female subjects participating in the study should be counselled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of human immune virus (HIV) transmission to an uninfected partner. * Subjects capable of giving signed informed consent. * For participation in Part 1, documentation that the subject is negative for the human leukocyte antigen (HLA)-B\*5701 allele.
Exclusion criteria
* The medical conditions included where ALT and bilirubin \>1.5 × upper limit of normal (ULN) (isolated bilirubin \>1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin \< =35%). * Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration-time Curve (AUC) From Time of Dose Extrapolated to Infinity (AUC[0-inf]) in Part 1 of DTG | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. PK population comprised of participants in the all participants population (participants who took at least 1 dose of study medication) for whom PK sample was obtained and who had evaluable PK assay results. Statistics has been presented on geometric least square (LS) means. |
| AUC From Time of Dose to Last Measurable Concentration (AUC[0-t]) in Part 1 of DTG | Pre-dose,15 and 30 minutes,1 ,1.5 ,2 ,2.5 ,3 ,4 ,5 ,6 ,8 ,12 ,16 ,24 ,48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. |
| Maximum Observed Concentration (Cmax) in Part 1 of DTG in Plasma | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. |
| AUC(0-inf) in Part 1 of ABC | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. |
| AUC(0-t) in Part 1 of ABC | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. |
| Cmax in Part 1 of ABC in Plasma | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. |
| AUC(0-inf) in Part 1 of 3TC | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. |
| AUC (0-t) in Part 1 of 3TC | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. |
| Cmax in Part 1 of 3TC | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means |
| AUC(0-inf) in Part 2 of DTG in Plasma | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. |
| AUC(0-t) in Part 2 of DTG | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. |
| Cmax in Part 2 of DTG in Plasma | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. |
| AUC(0-inf) in Part 2 of 3TC | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. |
| AUC(0-t) in Part 2 of 3TC | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. |
| Cmax in Part 2 of 3TC | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ct of ABC in Plasma in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| T½ of ABC in Plasma in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| AUC(0-24) of 3TC in Plasma in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Tmax of 3TC in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Tlast of 3TC in Plasma in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| CL/F of 3TC in Plasma in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Vz/F of 3TC in Plasma in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| C24 of 3TC in Plasma in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. |
| Ct of 3TC in Plasma in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| T½ of 3TC in Plasma in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| AUC (0-24) of DTG in Plasma in Part 2 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Tmax of DTG in Plasma in Part 2 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Tlast of DTG in Plasma in Part 2 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| CL/F of DTG in Plasma in Part 2 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Vz/F of DTG in Plasma in Part 2 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| C24 of DTG in Plasma in Part 2 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. |
| Change From Baseline Values for Hemocrit in Part 1 | Baseline (Day -1) and Day 2 | Blood samples were collected for the analysis hemocrit in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value. |
| Ct of DTG in Plasma in Part 2 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| T½ of DTG in Plasma in Part 2 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Tlag of DTG in Plasma in Part 2 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| AUC (0-24) of 3TC in Plasma in Part 2 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Tmax of 3TC in Plasma in Part 2 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Tlast of 3TC in Plasma in Part 2 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| CL/F of 3TC in Plasma in Part 2 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Vz/F of 3TC in Plasma in Part 2 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| C24 of 3TC in Plasma in Part 2 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. |
| Ct of 3TC in Plasma in Part 2 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| T½ of 3TC in Plasma in Part 2 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) in Part 1 | Up to Day 33 | 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. 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, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety population comprised of all participants enrolled in the study, who took at least one dose of study treatment. |
| Number of Participants With AEs and Serious Adverse Events SAEs in Part 2 | Up to Day 33 | 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. 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, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. |
| Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Day 2 of each treatment period | Blood samples were collected for the analysis of clinical chemistry parameters which included glucose, calcium, potassium, sodium and urea. All participants population included all participants who received at least one dose of study medication. This population corresponded to all participants enrolled. |
| Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotranferase (AST) and Creatinine Phosphokinase (CPK) | Day 2 of each treatment period | Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK. |
| Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein | Day 2 of each treatment period | Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. |
| Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin | Day 2 of each treatment period | Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. |
| Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Day 2 of each treatment period | Blood samples were collected for the analysis of clinical chemistry parameters including glucose, calcium, potassium, sodium and urea. |
| Absolute Values for Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | Day 2 of each treatment period | Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK. |
| Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein | Day 2 of each treatment period | Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. |
| Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin | Day 2 of each treatment period | Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. |
| Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Baseline (Day -1) and Day 2 | Blood samples were collected for the analysis of clinical chemistry parameters including glucose, calcium, potassium, sodium and urea. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: ALT, ALP, AST and CPK | Baseline (Day -1) and Day 2 | Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein | Baseline (Day -1) and Day 2 | Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin | Baseline (Day -1) and Day 2 | Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Baseline (Day -1) and Day 2 | Blood samples were collected for the analysis of clinical chemistry parameters including glucose, calcium, potassium, sodium and urea. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | Baseline (Day -1) and Day 2 | Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein | Baseline (Day -1) and Day 2 | Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin | Baseline (Day -1) and Day 2 | Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Day 2 of each treatment period | Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 1 at indicated time points. |
| Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1 | Day 2 of each treatment period | Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points. |
| Absolute Values for Erythrocytes in Part 1 | Day 2 of each treatment period | Blood samples were collected for the analysis erythrocytes in Part 1 at indicated time points. |
| Absolute Values for Hemocrit in Part 1 | Day 2 of each treatment period | Blood samples were collected for the analysis hemocrit in Part 1 at indicated time points. |
| Absolute Values for Hemoglobin in Part 1 | Day 2 of each treatment period | Blood samples were collected for the analysis hemoglobin in Part 1 at indicated time points. |
| Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Day 2 of each treatment period | Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 2 at indicated time points. |
| Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 2 | Day 2 of each treatment period | Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points. |
| Absolute Values for Erythrocyte Mean Corpuscular Volume in Part 2 | Day 2 of each treatment period | Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points. |
| Absolute Values for Erythrocytes in Part 2 | Day 2 of each treatment period | Blood samples were collected for the analysis erythrocytes in Part 2 at indicated time points. |
| Absolute Values for Hemocrit in Part 2 | Day 2 of each treatment period | Blood samples were collected for the analysis hemocrit in Part 2 at indicated time points. |
| Absolute Values for Hemoglobin in Part 2 | Day 2 of each treatment period | Blood samples were collected for the analysis hemoglobin in Part 2 at indicated time points. |
| AUC From Time of Dose to 24 Hours (AUC[0-24]) of DTG in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Change From Baseline Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1 | Baseline (Day -1) and Day 2 | Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value. |
| Change From Baseline Values for Erythrocyte Mean Corpuscular Volume in Part 1 | Baseline (Day -1) and Day 2 | Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value. |
| Change From Baseline Values for Erythrocytes in Part 1 | Baseline (Day -1) and Day 2 | Blood samples were collected for the analysis erythrocytes in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value. |
| Change From Baseline Values for Hemoglobin in Part 1 | Baseline (Day -1) and Day 2 | Blood samples were collected for the analysis hemoglobin in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value. |
| Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Baseline (Day -1) and Day 2 | Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value. |
| Change From Baseline Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 2 | Baseline (Day -1) and Day 2 | Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value. |
| Change From Baseline Values for Erythrocyte Mean Corpuscular Volume in Part 2 | Baseline (Day -1) and Day 2 | Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value. |
| Change From Baseline Values for Erythrocytes in Part 2 | Baseline (Day -1) and Day 2 | Blood samples were collected for the analysis erythrocytes in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value. |
| Change From Baseline Values for Hemocrit in Part 2 | Baseline (Day -1) and Day 2 | Blood samples were collected for the analysis hemocrit in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value. |
| Change From Baseline Values for Hemoglobin in Part 2 | Baseline (Day -1) and Day 2 | Blood samples were collected for the analysis hemoglobin in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value. |
| Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Up to Day 33 | The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as increased, decreased, increase to trace, 1+ and 3+ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented. |
| Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | Up to Day 33 | Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). |
| Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Up to Day 33 | The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as increased, decreased, increase to trace, 1+ and 3+ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented. |
| Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | Up to Day 33 | Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Part 1 | Baseline (Day -1) | Full 12-lead ECGs were recorded with the participant in a supine position. Absolute QTc Interval: \>450, absolute PR Interval: \<110 and Absolute QRS Interval: \<75 were considered to be potential clinically significant ECG finding. The number of participants with abnormal clinically significant ECG findings are presented. |
| Number of Participants With Abnormal ECG Findings in Part 2 | Baseline (Day -1) | Full 12-lead ECGs were recorded with the participant in a supine position. Absolute QTc Interval: \>450, absolute PR Interval: \<110 and Absolute QRS Interval: \<75 were considered to be potential clinically significant ECG finding. The number of participants with abnormal clinically significant ECG findings are presented |
| Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Part 1 | Day 1 at 4 hours post intervention and Day 2 of each treatment period | Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest. |
| Absolute Values for Pulse Rate in Part 1 | Day 1 at 4 hours post intervention and Day 2 of each treatment period | Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. |
| Absolute Values for Temperature in Part 1 | Day 1 at 4 hours post intervention dose and Day 2 of each treatment period | Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest. |
| Absolute Values for SBP and DBP of Part 2 | Day 1 at 4 hours post intervention dose and Day 2 of each treatment period | Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest. |
| Absolute Values for Pulse Rate in Part 2 | Day 1 at 4 hours post intervention dose and Day 2 of each treatment period | Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. |
| Absolute Values for Temperature in Part 2 | Day 1 at 4 hours post intervention dose and Day 2 of each treatment period | Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest. |
| Change From Baseline in SBP and DBP of Part 1 | Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2 | Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline in Pulse Rate of Part 1 | Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2 | Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline in Temperature of Part 1 | Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2 | Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline in SBP and DBP of Part 2 | Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2 | Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline in Pulse Rate in Part 2 | Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2 | Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline in Temperature in Part 2 | Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2 | Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Baseline (Day -1) and Day 2 | Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value. |
| Time to Maximum Concentration (Tmax) of DTG in Plasma in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Time of Last Quantifiable Concentration (Tlast) of DTG in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Apparent Oral Clearance (CL/F) of DTG in Plasma in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Apparent Volume of Distribution (Vz/F) of DTG in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Observed Concentration at 24 Hours Postdose (C24) of DTG in Plasma in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. |
| Last Observed Quantifiable Concentration (Ct) of DTG in Plasma in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Terminal Elimination Phase Half-life (t½) of DTG in Plasma in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Lag Time for Absorption (Tlag) of DTG in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| AUC(0-24) of ABC in Plasma in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Tmax of ABC in Plasma in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Tlast of ABC in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| CL/F of ABC in Plasma in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| Vz/F of ABC in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. |
| C24 of ABC in Plasma in Part 1 | Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period | Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means. |
Countries
United States
Participant flow
Recruitment details
This was a 2-Part, Phase I, Single-Dose, 3-Period Crossover Relative Bioavailability Study of a Pediatric TRIUMEQ Dispersible Tablet and Pediatric Dolutegravir and Lamivudine (DTG/3TC) Fixed Dose Combination Dispersible Tablet Formulations as Compared with Adult Tablets in Healthy Participants.
Pre-assignment details
A total of 36 participants were enrolled for Part 1 and 2 of the study at a single-center in the United States. Each participant received all 3 treatments according to their assignment to one of the 6 treatment sequences in Part 1 and 2.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants in Part 1 All participants received either treatment A or B or C in 6 treatment sequences: ABC, BCA, CAB, ACB, CBA and BAC | 18 |
| All Study Participants in Part 2 All participants received either treatment D or E or F in 6 treatment sequences: DEF, EFD, FDE, DFE, EDF and FED | 18 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1: Period 2 (Up to Day 4 ) | Positive urine drug screen lab value | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | All Study Participants in Part 2 | Total | All Study Participants in Part 1 |
|---|---|---|---|
| Age, Continuous | 33.9 Years STANDARD_DEVIATION 8.47 | 34.4 Years STANDARD_DEVIATION 9.19 | 34.9 Years STANDARD_DEVIATION 10.08 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian-Central/South Asian Heritage | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian-Japanese/East/South-East Asian Heritage | 4 Participants | 4 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 11 Participants | 5 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 8 Participants | 20 Participants | 12 Participants |
| Sex: Female, Male Female | 5 Participants | 14 Participants | 9 Participants |
| Sex: Female, Male Male | 13 Participants | 22 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 1 / 17 | 1 / 17 | 2 / 18 | 1 / 18 | 0 / 18 | 1 / 18 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 |
Outcome results
Primary
Area Under the Plasma Concentration-time Curve (AUC) From Time of Dose Extrapolated to Infinity (AUC[0-inf]) in Part 1 of DTG
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. PK population comprised of participants in the all participants population (participants who took at least 1 dose of study medication) for whom PK sample was obtained and who had evaluable PK assay results. Statistics has been presented on geometric least square (LS) means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Area Under the Plasma Concentration-time Curve (AUC) From Time of Dose Extrapolated to Infinity (AUC[0-inf]) in Part 1 of DTG | 59.761 Hours*microgram per milliliter | Geometric Coefficient of Variation 31 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Area Under the Plasma Concentration-time Curve (AUC) From Time of Dose Extrapolated to Infinity (AUC[0-inf]) in Part 1 of DTG | 101.125 Hours*microgram per milliliter | Geometric Coefficient of Variation 22 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Area Under the Plasma Concentration-time Curve (AUC) From Time of Dose Extrapolated to Infinity (AUC[0-inf]) in Part 1 of DTG | 77.742 Hours*microgram per milliliter | Geometric Coefficient of Variation 29 |
90% CI: [1.569, 1.8373]
90% CI: [1.2465, 1.4647]
90% CI: [1.1569, 1.3595]
Primary
AUC(0-inf) in Part 1 of 3TC
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | AUC(0-inf) in Part 1 of 3TC | 13.087 Hours*microgram per milliliter | Geometric Coefficient of Variation 26 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | AUC(0-inf) in Part 1 of 3TC | 13.062 Hours*microgram per milliliter | Geometric Coefficient of Variation 24 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | AUC(0-inf) in Part 1 of 3TC | 12.155 Hours*microgram per milliliter | Geometric Coefficient of Variation 30 |
90% CI: [0.9536, 1.0486]
90% CI: [0.9039, 0.9939]
90% CI: [1.0061, 1.1063]
Primary
AUC(0-inf) in Part 1 of ABC
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | AUC(0-inf) in Part 1 of ABC | 16.636 Hours*microgram per milliliter | Geometric Coefficient of Variation 21 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | AUC(0-inf) in Part 1 of ABC | 17.321 Hours*microgram per milliliter | Geometric Coefficient of Variation 20 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | AUC(0-inf) in Part 1 of ABC | 16.756 Hours*microgram per milliliter | Geometric Coefficient of Variation 22 |
90% CI: [1.0118, 1.0704]
90% CI: [0.9944, 1.052]
90% CI: [0.9893, 1.0465]
Primary
AUC(0-inf) in Part 2 of 3TC
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | AUC(0-inf) in Part 2 of 3TC | 12.245 Hours*microgram per milliliter | Geometric Coefficient of Variation 17 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | AUC(0-inf) in Part 2 of 3TC | 12.149 Hours*microgram per milliliter | Geometric Coefficient of Variation 21 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | AUC(0-inf) in Part 2 of 3TC | 11.910 Hours*microgram per milliliter | Geometric Coefficient of Variation 20 |
90% CI: [0.9241, 1.0389]
90% CI: [0.9059, 1.0185]
90% CI: [0.9633, 1.0802]
Primary
AUC(0-inf) in Part 2 of DTG in Plasma
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | AUC(0-inf) in Part 2 of DTG in Plasma | 53.942 Hours*microgram per milliliter | Geometric Coefficient of Variation 38 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | AUC(0-inf) in Part 2 of DTG in Plasma | 88.676 Hours*microgram per milliliter | Geometric Coefficient of Variation 31 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | AUC(0-inf) in Part 2 of DTG in Plasma | 68.496 Hours*microgram per milliliter | Geometric Coefficient of Variation 32 |
90% CI: [1.4649, 1.8449]
90% CI: [1.1315, 1.425]
90% CI: [1.1536, 1.4529]
Primary
AUC (0-t) in Part 1 of 3TC
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | AUC (0-t) in Part 1 of 3TC | 12.857 Hours*microgram per milliliter | Geometric Coefficient of Variation 26 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | AUC (0-t) in Part 1 of 3TC | 12.829 Hours*microgram per milliliter | Geometric Coefficient of Variation 24 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | AUC (0-t) in Part 1 of 3TC | 11.893 Hours*microgram per milliliter | Geometric Coefficient of Variation 29 |
90% CI: [0.9525, 1.0486]
90% CI: [0.899, 0.9896]
90% CI: [1.0099, 1.1117]
Primary
AUC(0-t) in Part 1 of ABC
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | AUC(0-t) in Part 1 of ABC | 16.609 Hours*microgram per milliliter | Geometric Coefficient of Variation 21 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | AUC(0-t) in Part 1 of ABC | 17.298 Hours*microgram per milliliter | Geometric Coefficient of Variation 20 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | AUC(0-t) in Part 1 of ABC | 16.735 Hours*microgram per milliliter | Geometric Coefficient of Variation 22 |
90% CI: [1.0121, 1.0708]
90% CI: [0.9948, 1.0524]
90% CI: [0.9892, 1.0465]
Primary
AUC(0-t) in Part 2 of 3TC
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | AUC(0-t) in Part 2 of 3TC | 11.991 Hours*microgram per milliliter | Geometric Coefficient of Variation 16 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | AUC(0-t) in Part 2 of 3TC | 11.788 Hours*microgram per milliliter | Geometric Coefficient of Variation 20 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | AUC(0-t) in Part 2 of 3TC | 11.633 Hours*microgram per milliliter | Geometric Coefficient of Variation 19 |
90% CI: [0.9243, 1.0457]
90% CI: [0.9121, 1.032]
90% CI: [0.9527, 1.0779]
Primary
AUC(0-t) in Part 2 of DTG
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | AUC(0-t) in Part 2 of DTG | 51.477 Hours*microgram per milliliter | Geometric Coefficient of Variation 38 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | AUC(0-t) in Part 2 of DTG | 85.340 Hours*microgram per milliliter | Geometric Coefficient of Variation 30 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | AUC(0-t) in Part 2 of DTG | 65.657 Hours*microgram per milliliter | Geometric Coefficient of Variation 31 |
90% CI: [1.4709, 1.8685]
90% CI: [1.1317, 1.4375]
90% CI: [1.1533, 1.465]
Primary
AUC From Time of Dose to Last Measurable Concentration (AUC[0-t]) in Part 1 of DTG
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose,15 and 30 minutes,1 ,1.5 ,2 ,2.5 ,3 ,4 ,5 ,6 ,8 ,12 ,16 ,24 ,48 and 72 hours post-dose of each treatment period
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | AUC From Time of Dose to Last Measurable Concentration (AUC[0-t]) in Part 1 of DTG | 57.571 Hours*microgram per milliliter | Geometric Coefficient of Variation 29 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | AUC From Time of Dose to Last Measurable Concentration (AUC[0-t]) in Part 1 of DTG | 97.746 Hours*microgram per milliliter | Geometric Coefficient of Variation 21 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | AUC From Time of Dose to Last Measurable Concentration (AUC[0-t]) in Part 1 of DTG | 75.086 Hours*microgram per milliliter | Geometric Coefficient of Variation 28 |
90% CI: [1.5685, 1.8428]
90% CI: [1.2475, 1.465]
90% CI: [1.1605, 1.3629]
Primary
Cmax in Part 1 of 3TC
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Cmax in Part 1 of 3TC | 2.194 Micrograms per milliliter | Geometric Coefficient of Variation 29 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Cmax in Part 1 of 3TC | 2.053 Micrograms per milliliter | Geometric Coefficient of Variation 35 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Cmax in Part 1 of 3TC | 1.947 Micrograms per milliliter | Geometric Coefficient of Variation 34 |
90% CI: [0.8677, 1.0101]
90% CI: [0.8416, 0.9795]
90% CI: [0.9558, 1.1124]
Primary
Cmax in Part 1 of ABC in Plasma
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Cmax in Part 1 of ABC in Plasma | 5.084 Micrograms per milliliter | Geometric Coefficient of Variation 19 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Cmax in Part 1 of ABC in Plasma | 5.351 Micrograms per milliliter | Geometric Coefficient of Variation 19 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Cmax in Part 1 of ABC in Plasma | 4.891 Micrograms per milliliter | Geometric Coefficient of Variation 23 |
90% CI: [0.9885, 1.1223]
90% CI: [0.9167, 1.0405]
90% CI: [1.0123, 1.149]
Primary
Cmax in Part 2 of 3TC
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Cmax in Part 2 of 3TC | 2.276 Micrograms per milliliter | Geometric Coefficient of Variation 28 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Cmax in Part 2 of 3TC | 2.071 Micrograms per milliliter | Geometric Coefficient of Variation 27 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Cmax in Part 2 of 3TC | 2.093 Micrograms per milliliter | Geometric Coefficient of Variation 29 |
90% CI: [0.8196, 1.0102]
90% CI: [0.8285, 1.0212]
90% CI: [0.8911, 1.0983]
Primary
Cmax in Part 2 of DTG in Plasma
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Cmax in Part 2 of DTG in Plasma | 2.764 Micrograms per milliliter | Geometric Coefficient of Variation 44 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Cmax in Part 2 of DTG in Plasma | 5.461 Micrograms per milliliter | Geometric Coefficient of Variation 18 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Cmax in Part 2 of DTG in Plasma | 3.558 Micrograms per milliliter | Geometric Coefficient of Variation 28 |
90% CI: [1.7585, 2.2201]
90% CI: [1.1457, 1.4465]
90% CI: [1.366, 1.7245]
Primary
Maximum Observed Concentration (Cmax) in Part 1 of DTG in Plasma
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Maximum Observed Concentration (Cmax) in Part 1 of DTG in Plasma | 3.093 Micrograms per milliliter | Geometric Coefficient of Variation 20 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Maximum Observed Concentration (Cmax) in Part 1 of DTG in Plasma | 5.373 Micrograms per milliliter | Geometric Coefficient of Variation 15 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Maximum Observed Concentration (Cmax) in Part 1 of DTG in Plasma | 4.134 Micrograms per milliliter | Geometric Coefficient of Variation 21 |
90% CI: [1.5983, 1.8904]
90% CI: [1.2525, 1.4798]
90% CI: [1.1746, 1.3878]
Secondary
Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotranferase (AST) and Creatinine Phosphokinase (CPK)
Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK.
Time frame: Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotranferase (AST) and Creatinine Phosphokinase (CPK) | ALT | 15.3 International units per Liter | Standard Deviation 7.2 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotranferase (AST) and Creatinine Phosphokinase (CPK) | ALP | 54.4 International units per Liter | Standard Deviation 16.22 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotranferase (AST) and Creatinine Phosphokinase (CPK) | AST | 16.1 International units per Liter | Standard Deviation 3.35 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotranferase (AST) and Creatinine Phosphokinase (CPK) | CPK | 90.7 International units per Liter | Standard Deviation 57.16 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotranferase (AST) and Creatinine Phosphokinase (CPK) | CPK | 81.9 International units per Liter | Standard Deviation 39.34 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotranferase (AST) and Creatinine Phosphokinase (CPK) | ALT | 14.8 International units per Liter | Standard Deviation 5.47 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotranferase (AST) and Creatinine Phosphokinase (CPK) | AST | 16.1 International units per Liter | Standard Deviation 3.51 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotranferase (AST) and Creatinine Phosphokinase (CPK) | ALP | 55.1 International units per Liter | Standard Deviation 16.89 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotranferase (AST) and Creatinine Phosphokinase (CPK) | CPK | 95.8 International units per Liter | Standard Deviation 52.83 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotranferase (AST) and Creatinine Phosphokinase (CPK) | ALP | 54.4 International units per Liter | Standard Deviation 16.99 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotranferase (AST) and Creatinine Phosphokinase (CPK) | AST | 15.9 International units per Liter | Standard Deviation 3.29 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotranferase (AST) and Creatinine Phosphokinase (CPK) | ALT | 15.3 International units per Liter | Standard Deviation 5.8 |
Secondary
Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein
Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein.
Time frame: Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein | Albumin | 43.2 Grams per liter | Standard Deviation 2.82 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein | Protein | 70.7 Grams per liter | Standard Deviation 4.55 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein | Albumin | 42.9 Grams per liter | Standard Deviation 2.76 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein | Protein | 70.8 Grams per liter | Standard Deviation 4.59 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein | Albumin | 43.8 Grams per liter | Standard Deviation 2.58 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein | Protein | 71.9 Grams per liter | Standard Deviation 3.73 |
Secondary
Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin
Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin.
Time frame: Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin | Creatinine | 81.47 Micromoles per liter | Standard Deviation 14.774 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin | Bilirubin | 9.58 Micromoles per liter | Standard Deviation 3.35 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin | Direct bilirubin | 1.76 Micromoles per liter | Standard Deviation 0.469 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin | Creatinine | 82.73 Micromoles per liter | Standard Deviation 13.279 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin | Bilirubin | 9.88 Micromoles per liter | Standard Deviation 3.612 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin | Direct bilirubin | 1.88 Micromoles per liter | Standard Deviation 0.549 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin | Bilirubin | 9.99 Micromoles per liter | Standard Deviation 4.066 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin | Direct bilirubin | 1.94 Micromoles per liter | Standard Deviation 0.609 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin | Creatinine | 83.36 Micromoles per liter | Standard Deviation 13.647 |
Secondary
Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea
Blood samples were collected for the analysis of clinical chemistry parameters which included glucose, calcium, potassium, sodium and urea. All participants population included all participants who received at least one dose of study medication. This population corresponded to all participants enrolled.
Time frame: Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Sodium | 138.1 Millimoles per liter | Standard Deviation 2.19 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Potassium | 4.31 Millimoles per liter | Standard Deviation 0.269 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Glucose | 5.031 Millimoles per liter | Standard Deviation 0.3501 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Calcium | 2.377 Millimoles per liter | Standard Deviation 0.0577 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Urea | 4.096 Millimoles per liter | Standard Deviation 0.9369 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Potassium | 4.26 Millimoles per liter | Standard Deviation 0.243 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Glucose | 4.931 Millimoles per liter | Standard Deviation 0.3448 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Calcium | 2.371 Millimoles per liter | Standard Deviation 0.0775 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Sodium | 138.2 Millimoles per liter | Standard Deviation 1.48 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Urea | 4.293 Millimoles per liter | Standard Deviation 1.1218 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Urea | 4.203 Millimoles per liter | Standard Deviation 1.0572 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Sodium | 138.1 Millimoles per liter | Standard Deviation 1.55 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Glucose | 4.933 Millimoles per liter | Standard Deviation 0.3709 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Potassium | 4.28 Millimoles per liter | Standard Deviation 0.271 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Calcium | 2.384 Millimoles per liter | Standard Deviation 0.0704 |
Secondary
Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein
Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein.
Time frame: Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein | Albumin | 43.9 Grams per liter | Standard Deviation 3.02 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein | Protein | 72.1 Grams per liter | Standard Deviation 3.79 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein | Albumin | 43.1 Grams per liter | Standard Deviation 4.09 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein | Protein | 70.9 Grams per liter | Standard Deviation 4.11 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein | Albumin | 43.1 Grams per liter | Standard Deviation 3.5 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein | Protein | 71.2 Grams per liter | Standard Deviation 5.26 |
Secondary
Absolute Values for Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK
Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK.
Time frame: Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | ALT | 16.1 International units per liter | Standard Deviation 11.34 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | ALP | 60.0 International units per liter | Standard Deviation 18.87 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | AST | 16.5 International units per liter | Standard Deviation 5.93 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | CPK | 90.9 International units per liter | Standard Deviation 36.86 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | CPK | 86.4 International units per liter | Standard Deviation 33.82 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | ALT | 15.6 International units per liter | Standard Deviation 8.25 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | AST | 15.6 International units per liter | Standard Deviation 3.97 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | ALP | 58.8 International units per liter | Standard Deviation 17.53 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | CPK | 81.7 International units per liter | Standard Deviation 25.51 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | ALP | 58.9 International units per liter | Standard Deviation 17.72 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | AST | 15.7 International units per liter | Standard Deviation 4.96 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | ALT | 14.9 International units per liter | Standard Deviation 7.44 |
Secondary
Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin
Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin.
Time frame: Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin | Creatinine | 87.66 Micromoles per liter | Standard Deviation 16.43 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin | Bilirubin | 10.71 Micromoles per liter | Standard Deviation 2.872 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin | Direct bilirubin | 2.14 Micromoles per liter | Standard Deviation 0.451 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin | Creatinine | 87.97 Micromoles per liter | Standard Deviation 14.906 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin | Bilirubin | 10.60 Micromoles per liter | Standard Deviation 3.275 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin | Direct bilirubin | 2.11 Micromoles per liter | Standard Deviation 0.514 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin | Bilirubin | 10.58 Micromoles per liter | Standard Deviation 2.869 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin | Direct bilirubin | 2.12 Micromoles per liter | Standard Deviation 0.528 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin | Creatinine | 87.11 Micromoles per liter | Standard Deviation 16.453 |
Secondary
Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea
Blood samples were collected for the analysis of clinical chemistry parameters including glucose, calcium, potassium, sodium and urea.
Time frame: Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Potassium | 4.20 Millimoles per liter | Standard Deviation 0.252 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Calcium | 2.378 Millimoles per liter | Standard Deviation 0.0833 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Sodium | 138.2 Millimoles per liter | Standard Deviation 1.5 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Glucose | 4.938 Millimoles per liter | Standard Deviation 0.281 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Urea | 4.603 Millimoles per liter | Standard Deviation 0.7878 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Glucose | 4.941 Millimoles per liter | Standard Deviation 0.3829 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Calcium | 2.367 Millimoles per liter | Standard Deviation 0.1066 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Potassium | 4.10 Millimoles per liter | Standard Deviation 0.188 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Sodium | 138.3 Millimoles per liter | Standard Deviation 1.81 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Urea | 4.343 Millimoles per liter | Standard Deviation 0.8311 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Sodium | 138.3 Millimoles per liter | Standard Deviation 1.56 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Calcium | 2.366 Millimoles per liter | Standard Deviation 0.1098 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Glucose | 4.959 Millimoles per liter | Standard Deviation 0.3494 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Potassium | 4.09 Millimoles per liter | Standard Deviation 0.24 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Urea | 4.398 Millimoles per liter | Standard Deviation 0.843 |
Secondary
Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1
Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points.
Time frame: Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1 | 28.11 Picograms | Standard Deviation 2.625 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1 | 27.98 Picograms | Standard Deviation 2.58 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1 | 28.21 Picograms | Standard Deviation 2.585 |
Secondary
Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1
Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points.
Time frame: Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1 | 83.92 Femtoliter | Standard Deviation 5.899 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1 | 83.84 Femtoliter | Standard Deviation 5.81 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1 | 83.97 Femtoliter | Standard Deviation 5.683 |
Secondary
Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 2
Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points.
Time frame: Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 2 | 29.78 Picograms | Standard Deviation 1.582 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 2 | 29.79 Picograms | Standard Deviation 1.735 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 2 | 29.81 Picograms | Standard Deviation 1.673 |
Secondary
Absolute Values for Erythrocyte Mean Corpuscular Volume in Part 2
Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points.
Time frame: Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Erythrocyte Mean Corpuscular Volume in Part 2 | 88.43 Femtoliter | Standard Deviation 3.869 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Erythrocyte Mean Corpuscular Volume in Part 2 | 88.28 Femtoliter | Standard Deviation 3.867 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Erythrocyte Mean Corpuscular Volume in Part 2 | 88.34 Femtoliter | Standard Deviation 4.251 |
Secondary
Absolute Values for Erythrocytes in Part 1
Blood samples were collected for the analysis erythrocytes in Part 1 at indicated time points.
Time frame: Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Erythrocytes in Part 1 | 4.905 10^12 cells per liter | Standard Deviation 0.4495 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Erythrocytes in Part 1 | 4.884 10^12 cells per liter | Standard Deviation 0.4751 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Erythrocytes in Part 1 | 4.914 10^12 cells per liter | Standard Deviation 0.4296 |
Secondary
Absolute Values for Erythrocytes in Part 2
Blood samples were collected for the analysis erythrocytes in Part 2 at indicated time points.
Time frame: Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Erythrocytes in Part 2 | 4.812 10^12 cells per liter | Standard Deviation 0.4164 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Erythrocytes in Part 2 | 4.794 10^12 cells per liter | Standard Deviation 0.4969 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Erythrocytes in Part 2 | 4.776 10^12 cells per liter | Standard Deviation 0.4971 |
Secondary
Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1
Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 1 at indicated time points.
Time frame: Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Neutrophils | 3.505 10^9 cells per liter | Standard Deviation 1.2385 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Leukocytes | 5.86 10^9 cells per liter | Standard Deviation 1.452 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Platelets | 248.8 10^9 cells per liter | Standard Deviation 64.36 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Lymphocytes | 1.709 10^9 cells per liter | Standard Deviation 0.4699 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Basophils | 0.042 10^9 cells per liter | Standard Deviation 0.016 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Monocytes | 0.448 10^9 cells per liter | Standard Deviation 0.1305 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Eosinophils | 0.152 10^9 cells per liter | Standard Deviation 0.1202 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Basophils | 0.042 10^9 cells per liter | Standard Deviation 0.0129 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Monocytes | 0.436 10^9 cells per liter | Standard Deviation 0.155 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Leukocytes | 5.66 10^9 cells per liter | Standard Deviation 1.67 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Eosinophils | 0.145 10^9 cells per liter | Standard Deviation 0.0996 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Lymphocytes | 1.639 10^9 cells per liter | Standard Deviation 0.4326 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Platelets | 247.1 10^9 cells per liter | Standard Deviation 59.94 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Neutrophils | 3.395 10^9 cells per liter | Standard Deviation 1.5325 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Platelets | 258.5 10^9 cells per liter | Standard Deviation 67.34 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Neutrophils | 3.647 10^9 cells per liter | Standard Deviation 1.2145 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Basophils | 0.037 10^9 cells per liter | Standard Deviation 0.0141 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Eosinophils | 0.144 10^9 cells per liter | Standard Deviation 0.1151 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Lymphocytes | 1.672 10^9 cells per liter | Standard Deviation 0.5362 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Monocytes | 0.432 10^9 cells per liter | Standard Deviation 0.1002 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Leukocytes | 5.93 10^9 cells per liter | Standard Deviation 1.41 |
Secondary
Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2
Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 2 at indicated time points.
Time frame: Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Eosinophils | 0.099 10^9 cells per liter | Standard Deviation 0.0532 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Neutrophils | 2.940 10^9 cells per liter | Standard Deviation 1.2394 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Monocytes | 0.373 10^9 cells per liter | Standard Deviation 0.1229 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Basophils | 0.042 10^9 cells per liter | Standard Deviation 0.0186 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Platelets | 242.3 10^9 cells per liter | Standard Deviation 57.86 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Leukocytes | 5.01 10^9 cells per liter | Standard Deviation 1.513 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Lymphocytes | 1.555 10^9 cells per liter | Standard Deviation 0.4401 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Monocytes | 0.378 10^9 cells per liter | Standard Deviation 0.1367 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Basophils | 0.044 10^9 cells per liter | Standard Deviation 0.0253 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Eosinophils | 0.099 10^9 cells per liter | Standard Deviation 0.0543 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Lymphocytes | 1.584 10^9 cells per liter | Standard Deviation 0.5536 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Neutrophils | 2.885 10^9 cells per liter | Standard Deviation 0.8698 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Leukocytes | 4.98 10^9 cells per liter | Standard Deviation 1.232 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Platelets | 240.6 10^9 cells per liter | Standard Deviation 58.34 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Neutrophils | 2.931 10^9 cells per liter | Standard Deviation 0.907 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Eosinophils | 0.100 10^9 cells per liter | Standard Deviation 0.0508 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Platelets | 244.2 10^9 cells per liter | Standard Deviation 57.67 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Leukocytes | 4.98 10^9 cells per liter | Standard Deviation 1.24 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Monocytes | 0.369 10^9 cells per liter | Standard Deviation 0.1264 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Lymphocytes | 1.553 10^9 cells per liter | Standard Deviation 0.4647 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Basophils | 0.039 10^9 cells per liter | Standard Deviation 0.0171 |
Secondary
Absolute Values for Hemocrit in Part 1
Blood samples were collected for the analysis hemocrit in Part 1 at indicated time points.
Time frame: Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Hemocrit in Part 1 | 0.4101 Percentage of red blood cells in blood | Standard Deviation 0.03195 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Hemocrit in Part 1 | 0.4076 Percentage of red blood cells in blood | Standard Deviation 0.02824 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Hemocrit in Part 1 | 0.4114 Percentage of red blood cells in blood | Standard Deviation 0.03269 |
Secondary
Absolute Values for Hemocrit in Part 2
Blood samples were collected for the analysis hemocrit in Part 2 at indicated time points.
Time frame: Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Hemocrit in Part 2 | 0.4243 Percentage of red blood cells in blood | Standard Deviation 0.02589 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Hemocrit in Part 2 | 0.4219 Percentage of red blood cells in blood | Standard Deviation 0.03425 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Hemocrit in Part 2 | 0.4206 Percentage of red blood cells in blood | Standard Deviation 0.03425 |
Secondary
Absolute Values for Hemoglobin in Part 1
Blood samples were collected for the analysis hemoglobin in Part 1 at indicated time points.
Time frame: Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Hemoglobin in Part 1 | 137.2 Grams per liter | Standard Deviation 12.51 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Hemoglobin in Part 1 | 135.9 Grams per liter | Standard Deviation 11.13 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Hemoglobin in Part 1 | 138.1 Grams per liter | Standard Deviation 13.2 |
Secondary
Absolute Values for Hemoglobin in Part 2
Blood samples were collected for the analysis hemoglobin in Part 2 at indicated time points.
Time frame: Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Hemoglobin in Part 2 | 143.0 Grams per liter | Standard Deviation 9.57 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Hemoglobin in Part 2 | 142.3 Grams per liter | Standard Deviation 11.33 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Hemoglobin in Part 2 | 141.8 Grams per liter | Standard Deviation 11.79 |
Secondary
Absolute Values for Pulse Rate in Part 1
Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest.
Time frame: Day 1 at 4 hours post intervention and Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Pulse Rate in Part 1 | Day 1- 4hours | 59.5 Beats per minute | Standard Deviation 8.32 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Pulse Rate in Part 1 | Day 2 | 63.5 Beats per minute | Standard Deviation 8.21 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Pulse Rate in Part 1 | Day 1- 4hours | 61.6 Beats per minute | Standard Deviation 12.02 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Pulse Rate in Part 1 | Day 2 | 66.6 Beats per minute | Standard Deviation 10.04 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Pulse Rate in Part 1 | Day 1- 4hours | 59.7 Beats per minute | Standard Deviation 9.29 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Pulse Rate in Part 1 | Day 2 | 67.4 Beats per minute | Standard Deviation 9.6 |
Secondary
Absolute Values for Pulse Rate in Part 2
Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest.
Time frame: Day 1 at 4 hours post intervention dose and Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Pulse Rate in Part 2 | Day 1-4hours | 63.9 Beats per minute | Standard Deviation 14.95 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Pulse Rate in Part 2 | Day 2 | 67.7 Beats per minute | Standard Deviation 14.56 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Pulse Rate in Part 2 | Day 2 | 64.9 Beats per minute | Standard Deviation 12.36 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Pulse Rate in Part 2 | Day 1-4hours | 62.6 Beats per minute | Standard Deviation 11.25 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Pulse Rate in Part 2 | Day 1-4hours | 63.3 Beats per minute | Standard Deviation 13.64 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Pulse Rate in Part 2 | Day 2 | 66.5 Beats per minute | Standard Deviation 11.42 |
Secondary
Absolute Values for SBP and DBP of Part 2
Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.
Time frame: Day 1 at 4 hours post intervention dose and Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for SBP and DBP of Part 2 | SBP, Day 1- 4hours | 116.2 Millimeters of mercury | Standard Deviation 7.38 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for SBP and DBP of Part 2 | SBP, Day 2 | 116.0 Millimeters of mercury | Standard Deviation 8.01 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for SBP and DBP of Part 2 | DBP, Day 1-4 hours | 70.1 Millimeters of mercury | Standard Deviation 9.38 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for SBP and DBP of Part 2 | DBP, Day 2 | 69.5 Millimeters of mercury | Standard Deviation 6.49 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for SBP and DBP of Part 2 | DBP, Day 2 | 71.1 Millimeters of mercury | Standard Deviation 9.62 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for SBP and DBP of Part 2 | SBP, Day 1- 4hours | 118.9 Millimeters of mercury | Standard Deviation 13.31 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for SBP and DBP of Part 2 | DBP, Day 1-4 hours | 70.9 Millimeters of mercury | Standard Deviation 11.59 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for SBP and DBP of Part 2 | SBP, Day 2 | 115.5 Millimeters of mercury | Standard Deviation 9.2 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for SBP and DBP of Part 2 | DBP, Day 2 | 69.9 Millimeters of mercury | Standard Deviation 11.46 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for SBP and DBP of Part 2 | SBP, Day 2 | 113.2 Millimeters of mercury | Standard Deviation 11.62 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for SBP and DBP of Part 2 | DBP, Day 1-4 hours | 71.7 Millimeters of mercury | Standard Deviation 11.02 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for SBP and DBP of Part 2 | SBP, Day 1- 4hours | 119.1 Millimeters of mercury | Standard Deviation 13.73 |
Secondary
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Part 1
Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.
Time frame: Day 1 at 4 hours post intervention and Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Part 1 | SBP, Day 1- 4hours | 117.5 Millimeters of mercury | Standard Deviation 12.25 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Part 1 | SBP, Day 2 | 114.0 Millimeters of mercury | Standard Deviation 9.5 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Part 1 | DBP, Day 1- 4hours | 70.9 Millimeters of mercury | Standard Deviation 10.88 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Part 1 | DBP, Day 2 | 68.1 Millimeters of mercury | Standard Deviation 8.55 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Part 1 | DBP, Day 2 | 68.2 Millimeters of mercury | Standard Deviation 7.49 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Part 1 | SBP, Day 1- 4hours | 120.7 Millimeters of mercury | Standard Deviation 15.73 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Part 1 | DBP, Day 1- 4hours | 74.0 Millimeters of mercury | Standard Deviation 11.77 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Part 1 | SBP, Day 2 | 115.2 Millimeters of mercury | Standard Deviation 11.27 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Part 1 | DBP, Day 2 | 68.3 Millimeters of mercury | Standard Deviation 8.2 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Part 1 | SBP, Day 2 | 115.7 Millimeters of mercury | Standard Deviation 9.09 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Part 1 | DBP, Day 1- 4hours | 71.6 Millimeters of mercury | Standard Deviation 8.71 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Part 1 | SBP, Day 1- 4hours | 118.9 Millimeters of mercury | Standard Deviation 10.05 |
Secondary
Absolute Values for Temperature in Part 1
Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest.
Time frame: Day 1 at 4 hours post intervention dose and Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Temperature in Part 1 | Day 1- 4hours | 36.46 Degree celsius | Standard Deviation 0.433 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Temperature in Part 1 | Day 2 | 36.41 Degree celsius | Standard Deviation 0.372 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Temperature in Part 1 | Day 1- 4hours | 36.44 Degree celsius | Standard Deviation 0.411 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Temperature in Part 1 | Day 2 | 36.71 Degree celsius | Standard Deviation 0.347 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Temperature in Part 1 | Day 1- 4hours | 36.51 Degree celsius | Standard Deviation 0.362 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Temperature in Part 1 | Day 2 | 36.66 Degree celsius | Standard Deviation 0.415 |
Secondary
Absolute Values for Temperature in Part 2
Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest.
Time frame: Day 1 at 4 hours post intervention dose and Day 2 of each treatment period
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Temperature in Part 2 | Day 1-4hours | 36.31 Degree celsius | Standard Deviation 0.381 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Absolute Values for Temperature in Part 2 | Day 2 | 36.33 Degree celsius | Standard Deviation 0.401 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Temperature in Part 2 | Day 1-4hours | 36.28 Degree celsius | Standard Deviation 0.373 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Absolute Values for Temperature in Part 2 | Day 2 | 36.35 Degree celsius | Standard Deviation 0.228 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Temperature in Part 2 | Day 1-4hours | 36.39 Degree celsius | Standard Deviation 0.429 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Absolute Values for Temperature in Part 2 | Day 2 | 36.45 Degree celsius | Standard Deviation 0.343 |
Secondary
Apparent Oral Clearance (CL/F) of DTG in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Apparent Oral Clearance (CL/F) of DTG in Plasma in Part 1 | 0.8367 Liters per hour | Geometric Coefficient of Variation 31 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Apparent Oral Clearance (CL/F) of DTG in Plasma in Part 1 | 0.4944 Liters per hour | Geometric Coefficient of Variation 22 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Apparent Oral Clearance (CL/F) of DTG in Plasma in Part 1 | 0.6432 Liters per hour | Geometric Coefficient of Variation 29 |
Secondary
Apparent Volume of Distribution (Vz/F) of DTG in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Apparent Volume of Distribution (Vz/F) of DTG in Part 1 | 17.260 Liters | Geometric Coefficient of Variation 20 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Apparent Volume of Distribution (Vz/F) of DTG in Part 1 | 10.074 Liters | Geometric Coefficient of Variation 20 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Apparent Volume of Distribution (Vz/F) of DTG in Part 1 | 12.998 Liters | Geometric Coefficient of Variation 21 |
Secondary
AUC(0-24) of 3TC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | AUC(0-24) of 3TC in Plasma in Part 1 | 11.968 Hours*microgram per milliliter | Geometric Coefficient of Variation 26 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | AUC(0-24) of 3TC in Plasma in Part 1 | 11.927 Hours*microgram per milliliter | Geometric Coefficient of Variation 26 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | AUC(0-24) of 3TC in Plasma in Part 1 | 10.952 Hours*microgram per milliliter | Geometric Coefficient of Variation 30 |
Secondary
AUC (0-24) of 3TC in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | AUC (0-24) of 3TC in Plasma in Part 2 | 11.070 Hours*microgram per milliliter | Geometric Coefficient of Variation 18 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | AUC (0-24) of 3TC in Plasma in Part 2 | 10.802 Hours*microgram per milliliter | Geometric Coefficient of Variation 21 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | AUC (0-24) of 3TC in Plasma in Part 2 | 10.673 Hours*microgram per milliliter | Geometric Coefficient of Variation 20 |
Secondary
AUC(0-24) of ABC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | AUC(0-24) of ABC in Plasma in Part 1 | 16.619 Hours*microgram per milliliter | Geometric Coefficient of Variation 21 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | AUC(0-24) of ABC in Plasma in Part 1 | 17.300 Hours*microgram per milliliter | Geometric Coefficient of Variation 20 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | AUC(0-24) of ABC in Plasma in Part 1 | 16.743 Hours*microgram per milliliter | Geometric Coefficient of Variation 22 |
Secondary
AUC (0-24) of DTG in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | AUC (0-24) of DTG in Plasma in Part 2 | 35.742 Hours*microgram per milliliter | Geometric Coefficient of Variation 39 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | AUC (0-24) of DTG in Plasma in Part 2 | 61.220 Hours*microgram per milliliter | Geometric Coefficient of Variation 26 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | AUC (0-24) of DTG in Plasma in Part 2 | 46.205 Hours*microgram per milliliter | Geometric Coefficient of Variation 29 |
Secondary
AUC From Time of Dose to 24 Hours (AUC[0-24]) of DTG in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | AUC From Time of Dose to 24 Hours (AUC[0-24]) of DTG in Part 1 | 40.264 Hours*microgram per milliliter | Geometric Coefficient of Variation 23 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | AUC From Time of Dose to 24 Hours (AUC[0-24]) of DTG in Part 1 | 69.745 Hours*microgram per milliliter | Geometric Coefficient of Variation 17 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | AUC From Time of Dose to 24 Hours (AUC[0-24]) of DTG in Part 1 | 53.250 Hours*microgram per milliliter | Geometric Coefficient of Variation 22 |
Secondary
C24 of 3TC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | C24 of 3TC in Plasma in Part 1 | 37.963 Nanograms per millilter | Geometric Coefficient of Variation 29 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | C24 of 3TC in Plasma in Part 1 | 40.913 Nanograms per millilter | Geometric Coefficient of Variation 24 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | C24 of 3TC in Plasma in Part 1 | 42.434 Nanograms per millilter | Geometric Coefficient of Variation 27 |
90% CI: [0.9904, 1.1873]
90% CI: [1.0334, 1.2379]
90% CI: [0.876, 1.0493]
Secondary
C24 of 3TC in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | C24 of 3TC in Plasma in Part 2 | 35.808 Nanograms per millilter | Geometric Coefficient of Variation 21 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | C24 of 3TC in Plasma in Part 2 | 38.475 Nanograms per millilter | Geometric Coefficient of Variation 18 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | C24 of 3TC in Plasma in Part 2 | 38.336 Nanograms per millilter | Geometric Coefficient of Variation 24 |
90% CI: [0.9997, 1.1549]
90% CI: [0.9961, 1.1507]
90% CI: [0.9338, 1.0787]
Secondary
C24 of ABC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | C24 of ABC in Plasma in Part 1 | 4.862 Nanograms per millilter | Geometric Coefficient of Variation 45 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | C24 of ABC in Plasma in Part 1 | 4.491 Nanograms per millilter | Geometric Coefficient of Variation 56 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | C24 of ABC in Plasma in Part 1 | 4.274 Nanograms per millilter | Geometric Coefficient of Variation 26 |
90% CI: [0.848, 1.2392]
90% CI: [0.7592, 1.1103]
90% CI: [0.9376, 1.3295]
Secondary
C24 of DTG in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | C24 of DTG in Plasma in Part 2 | 825.313 Nanograms per millilter | Geometric Coefficient of Variation 39 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | C24 of DTG in Plasma in Part 2 | 1289.044 Nanograms per millilter | Geometric Coefficient of Variation 37 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | C24 of DTG in Plasma in Part 2 | 1034.078 Nanograms per millilter | Geometric Coefficient of Variation 33 |
90% CI: [1.3678, 1.7835]
90% CI: [1.0973, 1.4307]
90% CI: [1.0917, 1.4234]
Secondary
Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein
Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein | Albumin | 0.4 Grams per liter | Standard Deviation 2.06 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein | Protein | 1.9 Grams per liter | Standard Deviation 3.31 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein | Albumin | -0.3 Grams per liter | Standard Deviation 1.61 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein | Protein | 1.6 Grams per liter | Standard Deviation 3.12 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein | Albumin | 0.4 Grams per liter | Standard Deviation 1.94 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein | Protein | 2.1 Grams per liter | Standard Deviation 2.96 |
Secondary
Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: ALT, ALP, AST and CPK
Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: ALT, ALP, AST and CPK | ALT | -0.3 International units per Liter | Standard Deviation 1.69 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: ALT, ALP, AST and CPK | ALP | -2.6 International units per Liter | Standard Deviation 6.71 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: ALT, ALP, AST and CPK | AST | -1.4 International units per Liter | Standard Deviation 1.62 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: ALT, ALP, AST and CPK | CPK | -38.2 International units per Liter | Standard Deviation 65.11 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: ALT, ALP, AST and CPK | CPK | -25.1 International units per Liter | Standard Deviation 31.53 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: ALT, ALP, AST and CPK | ALT | -0.1 International units per Liter | Standard Deviation 2.05 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: ALT, ALP, AST and CPK | AST | -0.6 International units per Liter | Standard Deviation 1.58 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: ALT, ALP, AST and CPK | ALP | -0.5 International units per Liter | Standard Deviation 2.81 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: ALT, ALP, AST and CPK | CPK | -48.8 International units per Liter | Standard Deviation 83.77 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: ALT, ALP, AST and CPK | ALP | -0.2 International units per Liter | Standard Deviation 3.84 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: ALT, ALP, AST and CPK | AST | -1.6 International units per Liter | Standard Deviation 2.93 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: ALT, ALP, AST and CPK | ALT | -0.9 International units per Liter | Standard Deviation 1.51 |
Secondary
Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin
Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin | Bilirubin | 1.95 Micromoles per liter | Standard Deviation 2.482 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin | Direct bilirubin | 0.20 Micromoles per liter | Standard Deviation 0.409 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin | Creatinine | 13.61 Micromoles per liter | Standard Deviation 5.09 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin | Bilirubin | 2.20 Micromoles per liter | Standard Deviation 2.313 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin | Creatinine | 13.06 Micromoles per liter | Standard Deviation 4.805 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin | Direct bilirubin | 0.30 Micromoles per liter | Standard Deviation 0.361 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin | Direct bilirubin | 0.26 Micromoles per liter | Standard Deviation 0.455 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin | Creatinine | 13.62 Micromoles per liter | Standard Deviation 3.782 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin | Bilirubin | 1.63 Micromoles per liter | Standard Deviation 2.479 |
Secondary
Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea
Blood samples were collected for the analysis of clinical chemistry parameters including glucose, calcium, potassium, sodium and urea. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Sodium | -1.0 Millimoles per liter | Standard Deviation 1.73 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Calcium | 0.023 Millimoles per liter | Standard Deviation 0.0701 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Urea | 0.361 Millimoles per liter | Standard Deviation 0.8156 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Glucose | 0.045 Millimoles per liter | Standard Deviation 0.4204 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Potassium | 0.18 Millimoles per liter | Standard Deviation 0.256 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Glucose | -0.068 Millimoles per liter | Standard Deviation 0.3312 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Sodium | -1.0 Millimoles per liter | Standard Deviation 1.46 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Potassium | 0.17 Millimoles per liter | Standard Deviation 0.306 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Urea | 0.386 Millimoles per liter | Standard Deviation 0.8436 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Calcium | 0.026 Millimoles per liter | Standard Deviation 0.0696 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Urea | 0.027 Millimoles per liter | Standard Deviation 1.149 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Calcium | 0.026 Millimoles per liter | Standard Deviation 0.0535 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Potassium | 0.12 Millimoles per liter | Standard Deviation 0.411 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Sodium | -0.6 Millimoles per liter | Standard Deviation 1.34 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea | Glucose | -0.115 Millimoles per liter | Standard Deviation 0.3774 |
Secondary
Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein
Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein | Albumin | -0.1 Grams per liter | Standard Deviation 2.15 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein | Protein | 1.1 Grams per liter | Standard Deviation 4.32 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein | Albumin | -0.1 Grams per liter | Standard Deviation 2.54 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein | Protein | 1.1 Grams per liter | Standard Deviation 4.3 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein | Albumin | -0.6 Grams per liter | Standard Deviation 2.45 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein | Protein | 0.6 Grams per liter | Standard Deviation 4.2 |
Secondary
Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK
Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | ALT | -1.2 International units per liter | Standard Deviation 3.26 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | ALP | -1.7 International units per liter | Standard Deviation 5.24 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | AST | -2.1 International units per liter | Standard Deviation 3.49 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | CPK | -34.2 International units per liter | Standard Deviation 38.44 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | CPK | -40.3 International units per liter | Standard Deviation 41.91 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | ALT | -2.0 International units per liter | Standard Deviation 3.4 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | AST | -2.9 International units per liter | Standard Deviation 3.61 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | ALP | -3.4 International units per liter | Standard Deviation 6.06 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | CPK | -33.2 International units per liter | Standard Deviation 30.98 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | ALP | -0.7 International units per liter | Standard Deviation 4.13 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | AST | -2.2 International units per liter | Standard Deviation 3.73 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK | ALT | -0.9 International units per liter | Standard Deviation 2.85 |
Secondary
Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin
Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin | Creatinine | 10.08 Micromoles per liter | Standard Deviation 7.023 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin | Bilirubin | 1.84 Micromoles per liter | Standard Deviation 1.974 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin | Direct bilirubin | 0.22 Micromoles per liter | Standard Deviation 0.352 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin | Creatinine | 10.32 Micromoles per liter | Standard Deviation 6.185 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin | Bilirubin | 1.56 Micromoles per liter | Standard Deviation 2.848 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin | Direct bilirubin | 0.20 Micromoles per liter | Standard Deviation 0.47 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin | Bilirubin | 1.91 Micromoles per liter | Standard Deviation 2.563 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin | Direct bilirubin | 0.26 Micromoles per liter | Standard Deviation 0.434 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin | Creatinine | 10.83 Micromoles per liter | Standard Deviation 6.796 |
Secondary
Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea
Blood samples were collected for the analysis of clinical chemistry parameters including glucose, calcium, potassium, sodium and urea. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Glucose | -0.128 Millimoles per liter | Standard Deviation 0.3363 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Sodium | -0.7 Millimoles per liter | Standard Deviation 1.93 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Calcium | 0.016 Millimoles per liter | Standard Deviation 0.0708 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Potassium | 0.06 Millimoles per liter | Standard Deviation 0.268 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Urea | 0.176 Millimoles per liter | Standard Deviation 1.0267 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Calcium | 0.019 Millimoles per liter | Standard Deviation 0.0687 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Urea | 0.084 Millimoles per liter | Standard Deviation 1.1918 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Potassium | -0.02 Millimoles per liter | Standard Deviation 0.411 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Sodium | -1.3 Millimoles per liter | Standard Deviation 1.78 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Glucose | -0.107 Millimoles per liter | Standard Deviation 0.35 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Sodium | -0.6 Millimoles per liter | Standard Deviation 2.38 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Calcium | -0.004 Millimoles per liter | Standard Deviation 0.0846 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Urea | 0.414 Millimoles per liter | Standard Deviation 0.8744 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Glucose | -0.175 Millimoles per liter | Standard Deviation 0.4178 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea | Potassium | -0.11 Millimoles per liter | Standard Deviation 0.347 |
Secondary
Change From Baseline in Pulse Rate in Part 2
Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Pulse Rate in Part 2 | Day 1-4hours | -4.7 Beats per minute | Standard Deviation 7.54 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Pulse Rate in Part 2 | Day 2 | -0.9 Beats per minute | Standard Deviation 7.76 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Pulse Rate in Part 2 | Day 1-4hours | -5.7 Beats per minute | Standard Deviation 9.38 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Pulse Rate in Part 2 | Day 2 | -3.3 Beats per minute | Standard Deviation 9.98 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Pulse Rate in Part 2 | Day 1-4hours | -8.6 Beats per minute | Standard Deviation 13.61 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Pulse Rate in Part 2 | Day 2 | -5.4 Beats per minute | Standard Deviation 14.18 |
Secondary
Change From Baseline in Pulse Rate of Part 1
Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Pulse Rate of Part 1 | Day 1- 4hours | -5.5 Beats per minute | Standard Deviation 7.31 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Pulse Rate of Part 1 | Day 2 | -1.5 Beats per minute | Standard Deviation 5.97 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Pulse Rate of Part 1 | Day 1- 4hours | -4.4 Beats per minute | Standard Deviation 5.91 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Pulse Rate of Part 1 | Day 2 | 0.5 Beats per minute | Standard Deviation 7.37 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Pulse Rate of Part 1 | Day 2 | -0.1 Beats per minute | Standard Deviation 8.79 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Pulse Rate of Part 1 | Day 1- 4hours | -7.8 Beats per minute | Standard Deviation 8.47 |
Secondary
Change From Baseline in SBP and DBP of Part 1
Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in SBP and DBP of Part 1 | DBP, Day 1- 4hours | -3.2 Millimeters of mercury | Standard Deviation 9.36 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in SBP and DBP of Part 1 | SBP, Day 2 | -3.4 Millimeters of mercury | Standard Deviation 5.94 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in SBP and DBP of Part 1 | SBP, Day 1- 4hours | 0.1 Millimeters of mercury | Standard Deviation 9.9 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in SBP and DBP of Part 1 | DBP, Day 2 | -6.1 Millimeters of mercury | Standard Deviation 5.21 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in SBP and DBP of Part 1 | SBP, Day 2 | -1.6 Millimeters of mercury | Standard Deviation 7.33 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in SBP and DBP of Part 1 | SBP, Day 1- 4hours | 3.9 Millimeters of mercury | Standard Deviation 10.59 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in SBP and DBP of Part 1 | DBP, Day 1- 4hours | 4.6 Millimeters of mercury | Standard Deviation 8.08 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in SBP and DBP of Part 1 | DBP, Day 2 | -1.2 Millimeters of mercury | Standard Deviation 5.23 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in SBP and DBP of Part 1 | DBP, Day 2 | -1.9 Millimeters of mercury | Standard Deviation 4.89 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in SBP and DBP of Part 1 | DBP, Day 1- 4hours | 1.3 Millimeters of mercury | Standard Deviation 6.51 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in SBP and DBP of Part 1 | SBP, Day 2 | -0.2 Millimeters of mercury | Standard Deviation 7.74 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in SBP and DBP of Part 1 | SBP, Day 1- 4hours | 3.1 Millimeters of mercury | Standard Deviation 8.54 |
Secondary
Change From Baseline in SBP and DBP of Part 2
Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in SBP and DBP of Part 2 | DBP, Day 2 | -1.5 Millimeters of mercury | Standard Deviation 6.69 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in SBP and DBP of Part 2 | SBP, Day 2 | -4.6 Millimeters of mercury | Standard Deviation 11.43 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in SBP and DBP of Part 2 | DBP, Day 1-4 hours | -0.9 Millimeters of mercury | Standard Deviation 5.79 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in SBP and DBP of Part 2 | SBP, Day 1- 4hours | -4.4 Millimeters of mercury | Standard Deviation 7.66 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in SBP and DBP of Part 2 | DBP, Day 2 | 0.7 Millimeters of mercury | Standard Deviation 6.86 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in SBP and DBP of Part 2 | SBP, Day 1- 4hours | 0.9 Millimeters of mercury | Standard Deviation 14.51 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in SBP and DBP of Part 2 | DBP, Day 1-4 hours | 0.5 Millimeters of mercury | Standard Deviation 7.73 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in SBP and DBP of Part 2 | SBP, Day 2 | -2.5 Millimeters of mercury | Standard Deviation 11.95 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in SBP and DBP of Part 2 | SBP, Day 2 | -8.3 Millimeters of mercury | Standard Deviation 9.86 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in SBP and DBP of Part 2 | DBP, Day 1-4 hours | -0.5 Millimeters of mercury | Standard Deviation 7.82 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in SBP and DBP of Part 2 | SBP, Day 1- 4hours | -2.4 Millimeters of mercury | Standard Deviation 8.63 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in SBP and DBP of Part 2 | DBP, Day 2 | -2.2 Millimeters of mercury | Standard Deviation 7.77 |
Secondary
Change From Baseline in Temperature in Part 2
Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Temperature in Part 2 | Day 1-4hours | -0.01 Degree celsius | Standard Deviation 0.508 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Temperature in Part 2 | Day 2 | 0.02 Degree celsius | Standard Deviation 0.522 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Temperature in Part 2 | Day 1-4hours | 0.05 Degree celsius | Standard Deviation 0.66 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Temperature in Part 2 | Day 2 | 0.12 Degree celsius | Standard Deviation 0.565 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Temperature in Part 2 | Day 1-4hours | -0.02 Degree celsius | Standard Deviation 0.514 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Temperature in Part 2 | Day 2 | 0.03 Degree celsius | Standard Deviation 0.469 |
Secondary
Change From Baseline in Temperature of Part 1
Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Temperature of Part 1 | Day 1- 4hours | 0.14 Degree celsius | Standard Deviation 0.55 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline in Temperature of Part 1 | Day 2 | 0.09 Degree celsius | Standard Deviation 0.365 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Temperature of Part 1 | Day 1- 4hours | 0.02 Degree celsius | Standard Deviation 0.256 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline in Temperature of Part 1 | Day 2 | 0.28 Degree celsius | Standard Deviation 0.251 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Temperature of Part 1 | Day 1- 4hours | 0.21 Degree celsius | Standard Deviation 0.454 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline in Temperature of Part 1 | Day 2 | 0.36 Degree celsius | Standard Deviation 0.412 |
Secondary
Change From Baseline Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1
Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Population: All Participants Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1 | 0.16 Picograms | Standard Deviation 0.394 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1 | 0.18 Picograms | Standard Deviation 0.303 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1 | 0.19 Picograms | Standard Deviation 0.367 |
Secondary
Change From Baseline Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 2
Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Population: All Participants Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 2 | 0.16 Picograms | Standard Deviation 0.403 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 2 | 0.07 Picograms | Standard Deviation 0.353 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 2 | -0.04 Picograms | Standard Deviation 0.335 |
Secondary
Change From Baseline Values for Erythrocyte Mean Corpuscular Volume in Part 1
Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Population: All Participants Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline Values for Erythrocyte Mean Corpuscular Volume in Part 1 | 0.09 Femtoliter | Standard Deviation 0.756 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline Values for Erythrocyte Mean Corpuscular Volume in Part 1 | 0.09 Femtoliter | Standard Deviation 0.634 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline Values for Erythrocyte Mean Corpuscular Volume in Part 1 | -0.01 Femtoliter | Standard Deviation 0.633 |
Secondary
Change From Baseline Values for Erythrocyte Mean Corpuscular Volume in Part 2
Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Population: All Participants Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline Values for Erythrocyte Mean Corpuscular Volume in Part 2 | 0.35 Femtoliter | Standard Deviation 0.678 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline Values for Erythrocyte Mean Corpuscular Volume in Part 2 | -0.01 Femtoliter | Standard Deviation 0.674 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline Values for Erythrocyte Mean Corpuscular Volume in Part 2 | 0.08 Femtoliter | Standard Deviation 0.666 |
Secondary
Change From Baseline Values for Erythrocytes in Part 1
Blood samples were collected for the analysis erythrocytes in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Population: All Participants Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline Values for Erythrocytes in Part 1 | 0.191 10^12 cells per liter | Standard Deviation 0.1562 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline Values for Erythrocytes in Part 1 | 0.121 10^12 cells per liter | Standard Deviation 0.1513 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline Values for Erythrocytes in Part 1 | 0.221 10^12 cells per liter | Standard Deviation 0.1443 |
Secondary
Change From Baseline Values for Erythrocytes in Part 2
Blood samples were collected for the analysis erythrocytes in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Population: All Participants Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline Values for Erythrocytes in Part 2 | 0.201 10^12 cells per liter | Standard Deviation 0.2539 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline Values for Erythrocytes in Part 2 | 0.224 10^12 cells per liter | Standard Deviation 0.2171 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline Values for Erythrocytes in Part 2 | 0.179 10^12 cells per liter | Standard Deviation 0.1813 |
Secondary
Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1
Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Leukocytes | -0.38 10^9 cells per liter | Standard Deviation 0.64 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Basophils | -0.009 10^9 cells per liter | Standard Deviation 0.0176 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Eosinophils | -0.013 10^9 cells per liter | Standard Deviation 0.0488 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Lymphocytes | -0.273 10^9 cells per liter | Standard Deviation 0.4366 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Monocytes | -0.082 10^9 cells per liter | Standard Deviation 0.1001 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Neutrophils | -0.008 10^9 cells per liter | Standard Deviation 0.5373 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Platelets | 7.1 10^9 cells per liter | Standard Deviation 12.27 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Neutrophils | -0.202 10^9 cells per liter | Standard Deviation 1.269 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Monocytes | -0.066 10^9 cells per liter | Standard Deviation 0.1332 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Basophils | -0.009 10^9 cells per liter | Standard Deviation 0.0162 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Lymphocytes | -0.325 10^9 cells per liter | Standard Deviation 0.4254 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Leukocytes | -0.61 10^9 cells per liter | Standard Deviation 1.356 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Eosinophils | -0.008 10^9 cells per liter | Standard Deviation 0.0323 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Platelets | -2.8 10^9 cells per liter | Standard Deviation 13.14 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Eosinophils | -0.014 10^9 cells per liter | Standard Deviation 0.0545 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Lymphocytes | -0.286 10^9 cells per liter | Standard Deviation 0.2468 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Platelets | 3.7 10^9 cells per liter | Standard Deviation 12.15 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Monocytes | -0.098 10^9 cells per liter | Standard Deviation 0.0818 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Neutrophils | -0.088 10^9 cells per liter | Standard Deviation 0.9868 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Basophils | -0.011 10^9 cells per liter | Standard Deviation 0.01 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1 | Leukocytes | -0.49 10^9 cells per liter | Standard Deviation 0.964 |
Secondary
Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2
Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Population: All Participants Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Eosinophils | 0.005 10^9 cells per liter | Standard Deviation 0.0367 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Neutrophils | -0.602 10^9 cells per liter | Standard Deviation 1.2902 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Monocytes | -0.074 10^9 cells per liter | Standard Deviation 0.0668 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Basophils | -0.004 10^9 cells per liter | Standard Deviation 0.0134 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Platelets | -5.4 10^9 cells per liter | Standard Deviation 22.31 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Leukocytes | -0.89 10^9 cells per liter | Standard Deviation 1.333 |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Lymphocytes | -0.207 10^9 cells per liter | Standard Deviation 0.2918 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Monocytes | -0.079 10^9 cells per liter | Standard Deviation 0.0608 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Basophils | -0.004 10^9 cells per liter | Standard Deviation 0.0142 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Eosinophils | -0.006 10^9 cells per liter | Standard Deviation 0.0315 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Lymphocytes | -0.219 10^9 cells per liter | Standard Deviation 0.2935 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Neutrophils | -0.497 10^9 cells per liter | Standard Deviation 0.6402 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Leukocytes | -0.81 10^9 cells per liter | Standard Deviation 0.755 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Platelets | 0.3 10^9 cells per liter | Standard Deviation 14.41 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Neutrophils | -0.487 10^9 cells per liter | Standard Deviation 0.7496 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Eosinophils | 0.004 10^9 cells per liter | Standard Deviation 0.0185 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Platelets | -2.7 10^9 cells per liter | Standard Deviation 17.91 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Leukocytes | -0.66 10^9 cells per liter | Standard Deviation 0.811 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Monocytes | -0.049 10^9 cells per liter | Standard Deviation 0.0972 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Lymphocytes | -0.115 10^9 cells per liter | Standard Deviation 0.2353 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2 | Basophils | -0.008 10^9 cells per liter | Standard Deviation 0.0142 |
Secondary
Change From Baseline Values for Hemocrit in Part 1
Blood samples were collected for the analysis hemocrit in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Population: All Participants Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline Values for Hemocrit in Part 1 | 0.0164 Percentage of red blood cells in blood | Standard Deviation 0.01412 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline Values for Hemocrit in Part 1 | 0.0099 Percentage of red blood cells in blood | Standard Deviation 0.01268 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline Values for Hemocrit in Part 1 | 0.0188 Percentage of red blood cells in blood | Standard Deviation 0.01373 |
Secondary
Change From Baseline Values for Hemocrit in Part 2
Blood samples were collected for the analysis hemocrit in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Population: All Participants Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline Values for Hemocrit in Part 2 | 0.0193 Percentage of red blood cells in blood | Standard Deviation 0.02273 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline Values for Hemocrit in Part 2 | 0.0195 Percentage of red blood cells in blood | Standard Deviation 0.01974 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline Values for Hemocrit in Part 2 | 0.0159 Percentage of red blood cells in blood | Standard Deviation 0.01427 |
Secondary
Change From Baseline Values for Hemoglobin in Part 1
Blood samples were collected for the analysis hemoglobin in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Population: All Participants Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline Values for Hemoglobin in Part 1 | 6.1 Grams per liter | Standard Deviation 4.19 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline Values for Hemoglobin in Part 1 | 4.0 Grams per liter | Standard Deviation 4.46 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline Values for Hemoglobin in Part 1 | 7.2 Grams per liter | Standard Deviation 4.96 |
Secondary
Change From Baseline Values for Hemoglobin in Part 2
Blood samples were collected for the analysis hemoglobin in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.
Time frame: Baseline (Day -1) and Day 2
Population: All Participants Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Change From Baseline Values for Hemoglobin in Part 2 | 6.9 Gram per liter | Standard Deviation 7.7 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Change From Baseline Values for Hemoglobin in Part 2 | 6.8 Gram per liter | Standard Deviation 5.52 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Change From Baseline Values for Hemoglobin in Part 2 | 5.1 Gram per liter | Standard Deviation 5.63 |
Secondary
CL/F of 3TC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | CL/F of 3TC in Plasma in Part 1 | 22.9237 Liters per hour | Geometric Coefficient of Variation 26 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | CL/F of 3TC in Plasma in Part 1 | 22.9679 Liters per hour | Geometric Coefficient of Variation 24 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | CL/F of 3TC in Plasma in Part 1 | 24.6802 Liters per hour | Geometric Coefficient of Variation 30 |
Secondary
CL/F of 3TC in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | CL/F of 3TC in Plasma in Part 2 | 24.4998 Liters per hour | Geometric Coefficient of Variation 17 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | CL/F of 3TC in Plasma in Part 2 | 24.6933 Liters per hour | Geometric Coefficient of Variation 21 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | CL/F of 3TC in Plasma in Part 2 | 25.1888 Liters per hour | Geometric Coefficient of Variation 20 |
Secondary
CL/F of ABC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | CL/F of ABC in Plasma in Part 1 | 36.0658 Liters per hour | Geometric Coefficient of Variation 21 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | CL/F of ABC in Plasma in Part 1 | 34.6391 Liters per hour | Geometric Coefficient of Variation 20 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | CL/F of ABC in Plasma in Part 1 | 35.8073 Liters per hour | Geometric Coefficient of Variation 22 |
Secondary
CL/F of DTG in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | CL/F of DTG in Plasma in Part 2 | 0.9269 Liters per hour | Geometric Coefficient of Variation 38 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | CL/F of DTG in Plasma in Part 2 | 0.5639 Liters per hour | Geometric Coefficient of Variation 31 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | CL/F of DTG in Plasma in Part 2 | 0.7300 Liters per hour | Geometric Coefficient of Variation 32 |
Secondary
Ct of 3TC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Ct of 3TC in Plasma in Part 1 | 6.552 Nanograms per milliliter | Geometric Coefficient of Variation 62 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Ct of 3TC in Plasma in Part 1 | 6.798 Nanograms per milliliter | Geometric Coefficient of Variation 53 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Ct of 3TC in Plasma in Part 1 | 7.251 Nanograms per milliliter | Geometric Coefficient of Variation 64 |
Secondary
Ct of 3TC in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Ct of 3TC in Plasma in Part 2 | 7.735 Nanograms per milliliter | Geometric Coefficient of Variation 62 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Ct of 3TC in Plasma in Part 2 | 8.417 Nanograms per milliliter | Geometric Coefficient of Variation 67 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Ct of 3TC in Plasma in Part 2 | 7.480 Nanograms per milliliter | Geometric Coefficient of Variation 64 |
Secondary
Ct of ABC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Ct of ABC in Plasma in Part 1 | 6.852 Nanograms per milliliter | Geometric Coefficient of Variation 74 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Ct of ABC in Plasma in Part 1 | 4.788 Nanograms per milliliter | Geometric Coefficient of Variation 58 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Ct of ABC in Plasma in Part 1 | 5.466 Nanograms per milliliter | Geometric Coefficient of Variation 55 |
Secondary
Ct of DTG in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Ct of DTG in Plasma in Part 2 | 95.829 Nanograms per milliliter | Geometric Coefficient of Variation 47 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Ct of DTG in Plasma in Part 2 | 131.216 Nanograms per milliliter | Geometric Coefficient of Variation 70 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Ct of DTG in Plasma in Part 2 | 107.749 Nanograms per milliliter | Geometric Coefficient of Variation 64 |
Secondary
Lag Time for Absorption (Tlag) of DTG in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Lag Time for Absorption (Tlag) of DTG in Part 1 | 0.00 Hours |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Lag Time for Absorption (Tlag) of DTG in Part 1 | 0.00 Hours |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Lag Time for Absorption (Tlag) of DTG in Part 1 | 0.00 Hours |
Secondary
Last Observed Quantifiable Concentration (Ct) of DTG in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Last Observed Quantifiable Concentration (Ct) of DTG in Plasma in Part 1 | 84.968 Nanograms per milliliter | Geometric Coefficient of Variation 83 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Last Observed Quantifiable Concentration (Ct) of DTG in Plasma in Part 1 | 138.258 Nanograms per milliliter | Geometric Coefficient of Variation 65 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Last Observed Quantifiable Concentration (Ct) of DTG in Plasma in Part 1 | 106.140 Nanograms per milliliter | Geometric Coefficient of Variation 80 |
Secondary
Number of Participants With Abnormal ECG Findings in Part 2
Full 12-lead ECGs were recorded with the participant in a supine position. Absolute QTc Interval: \>450, absolute PR Interval: \<110 and Absolute QRS Interval: \<75 were considered to be potential clinically significant ECG finding. The number of participants with abnormal clinically significant ECG findings are presented
Time frame: Baseline (Day -1)
Population: All Participants Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal ECG Findings in Part 2 | Not clinically significant | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal ECG Findings in Part 2 | Clinically significant | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal ECG Findings in Part 2 | Not clinically significant | 1 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal ECG Findings in Part 2 | Clinically significant | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal ECG Findings in Part 2 | Not clinically significant | 2 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal ECG Findings in Part 2 | Clinically significant | 0 Participants |
Secondary
Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Part 1
Full 12-lead ECGs were recorded with the participant in a supine position. Absolute QTc Interval: \>450, absolute PR Interval: \<110 and Absolute QRS Interval: \<75 were considered to be potential clinically significant ECG finding. The number of participants with abnormal clinically significant ECG findings are presented.
Time frame: Baseline (Day -1)
Population: All Participants Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Part 1 | Not clinically significant | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Part 1 | Clinically significant | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Part 1 | Not clinically significant | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Part 1 | Clinically significant | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Part 1 | Not clinically significant | 1 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Part 1 | Clinically significant | 0 Participants |
Secondary
Number of Participants With Abnormal Urinalysis Parameter in Part 1
The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as increased, decreased, increase to trace, 1+ and 3+ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented.
Time frame: Up to Day 33
Population: All Participants Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Glucose, No change/decrease | 17 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Glucose, Any increase | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Ketones, No change/decrease | 17 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Ketones, Increase to trace | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Occult blood, No change/decrease | 16 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Occult blood, Increase to trace | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Occult blood, Increase to 1+ | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Occult blood, Increase to 3+ | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Protein, No change/decrease | 17 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Protein, Any increase | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Protein, No change/decrease | 17 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Glucose, No change/decrease | 17 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Occult blood, Increase to trace | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Occult blood, No change/decrease | 17 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Glucose, Any increase | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Protein, Any increase | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Occult blood, Increase to 3+ | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Ketones, No change/decrease | 16 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Occult blood, Increase to 1+ | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Ketones, Increase to trace | 1 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Occult blood, Increase to 3+ | 1 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Ketones, Increase to trace | 1 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Occult blood, No change/decrease | 16 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Occult blood, Increase to trace | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Protein, No change/decrease | 18 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Occult blood, Increase to 1+ | 1 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Glucose, No change/decrease | 18 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Protein, Any increase | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Glucose, Any increase | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal Urinalysis Parameter in Part 1 | Ketones, No change/decrease | 17 Participants |
Secondary
Number of Participants With Abnormal Urinalysis Parameter in Part 2
The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as increased, decreased, increase to trace, 1+ and 3+ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented.
Time frame: Up to Day 33
Population: All Participants Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Ketones, Increase to trace | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Glucose, No change/decrease | 18 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Occult blood, Increase to trace | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Ketones, No change/decrease | 17 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Glucose, Any increase | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Occult blood Any increase | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Protein, No change/decrease | 18 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Occult blood, Increase to 3+ | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Occult blood, No change/decrease | 18 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Protein, Any increase | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Occult blood, Increase to 1+ | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Glucose, Any increase | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Occult blood Any increase | 1 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Occult blood, Increase to 3+ | 1 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Protein, No change/decrease | 18 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Protein, Any increase | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Glucose, No change/decrease | 18 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Ketones, No change/decrease | 18 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Ketones, Increase to trace | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Occult blood, No change/decrease | 17 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Occult blood, Increase to trace | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Occult blood, Increase to 1+ | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Occult blood, Increase to trace | 1 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Ketones, Increase to trace | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Protein, No change/decrease | 18 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Occult blood Any increase | 2 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Occult blood, No change/decrease | 16 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Occult blood, Increase to 3+ | 1 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Glucose, Any increase | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Glucose, No change/decrease | 18 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Occult blood, Increase to 1+ | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Ketones, No change/decrease | 18 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Abnormal Urinalysis Parameter in Part 2 | Protein, Any increase | 0 Participants |
Secondary
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) in Part 1
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. 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, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety population comprised of all participants enrolled in the study, who took at least one dose of study treatment.
Time frame: Up to Day 33
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) in Part 1 | Any AE | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) in Part 1 | Any SAE | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) in Part 1 | Any AE | 1 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) in Part 1 | Any SAE | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) in Part 1 | Any AE | 2 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) in Part 1 | Any SAE | 0 Participants |
Secondary
Number of Participants With AEs and Serious Adverse Events SAEs in Part 2
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. 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, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement.
Time frame: Up to Day 33
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With AEs and Serious Adverse Events SAEs in Part 2 | Any SAE | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With AEs and Serious Adverse Events SAEs in Part 2 | Any AE | 1 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With AEs and Serious Adverse Events SAEs in Part 2 | Any AE | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With AEs and Serious Adverse Events SAEs in Part 2 | Any SAE | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With AEs and Serious Adverse Events SAEs in Part 2 | Any AE | 1 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With AEs and Serious Adverse Events SAEs in Part 2 | Any SAE | 0 Participants |
Secondary
Number of Participants With Urine Potential of Hydrogen (pH)-Part 1
Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).
Time frame: Up to Day 33
Population: All Participants Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | Increase to 8.0 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | No change/decrease | 14 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | Increase to 6.0 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | Increase to 7.5 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | Increase to 6.5 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | Increase to 5.5 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | Any increase | 3 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | Increase to 7.0 | 1 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | Increase to 5.5 | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | Any increase | 3 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | Increase to 7.5 | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | No change/decrease | 14 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | Increase to 8.0 | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | Increase to 7.0 | 2 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | Increase to 6.0 | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | Increase to 6.5 | 1 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | Increase to 8.0 | 1 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | No change/decrease | 15 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | Any increase | 3 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | Increase to 5.5 | 1 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | Increase to 6.5 | 1 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | Increase to 7.0 | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | Increase to 7.5 | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Urine Potential of Hydrogen (pH)-Part 1 | Increase to 6.0 | 0 Participants |
Secondary
Number of Participants With Urine Potential of Hydrogen (pH)-Part 2
Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).
Time frame: Up to Day 33
Population: All Participants Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | No change/decrease | 11 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | Any increase | 7 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | Increase to 5.5 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | Increase to 6.0 | 1 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | Increase to 6.5 | 0 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | Increase to 7.0 | 4 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | Increase to 7.5 | 2 Participants |
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | Increase to 8.0 | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | Increase to 5.5 | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | Increase to 7.5 | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | Increase to 6.0 | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | Increase to 6.5 | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | Increase to 7.0 | 2 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | No change/decrease | 16 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | Any increase | 2 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | Increase to 8.0 | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | Increase to 5.5 | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | Any increase | 5 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | No change/decrease | 13 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | Increase to 6.0 | 1 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | Increase to 7.5 | 0 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | Increase to 7.0 | 2 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | Increase to 6.5 | 2 Participants |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Number of Participants With Urine Potential of Hydrogen (pH)-Part 2 | Increase to 8.0 | 0 Participants |
Secondary
Observed Concentration at 24 Hours Postdose (C24) of DTG in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Observed Concentration at 24 Hours Postdose (C24) of DTG in Plasma in Part 1 | 925.303 Nanograms per millilter | Geometric Coefficient of Variation 34 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Observed Concentration at 24 Hours Postdose (C24) of DTG in Plasma in Part 1 | 1523.534 Nanograms per millilter | Geometric Coefficient of Variation 28 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Observed Concentration at 24 Hours Postdose (C24) of DTG in Plasma in Part 1 | 1198.948 Nanograms per millilter | Geometric Coefficient of Variation 33 |
90% CI: [1.5131, 1.8]
90% CI: [1.2381, 1.4722]
90% CI: [1.121, 1.333]
Secondary
T½ of 3TC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | T½ of 3TC in Plasma in Part 1 | 17.969 Hours | Geometric Coefficient of Variation 36 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | T½ of 3TC in Plasma in Part 1 | 17.839 Hours | Geometric Coefficient of Variation 35 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | T½ of 3TC in Plasma in Part 1 | 18.057 Hours | Geometric Coefficient of Variation 39 |
Secondary
T½ of 3TC in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | T½ of 3TC in Plasma in Part 2 | 20.677 Hours | Geometric Coefficient of Variation 22 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | T½ of 3TC in Plasma in Part 2 | 21.299 Hours | Geometric Coefficient of Variation 32 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | T½ of 3TC in Plasma in Part 2 | 19.573 Hours | Geometric Coefficient of Variation 24 |
Secondary
T½ of ABC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | T½ of ABC in Plasma in Part 1 | 2.314 Hours | Geometric Coefficient of Variation 30 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | T½ of ABC in Plasma in Part 1 | 2.525 Hours | Geometric Coefficient of Variation 26 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | T½ of ABC in Plasma in Part 1 | 2.382 Hours | Geometric Coefficient of Variation 29 |
Secondary
T½ of DTG in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | T½ of DTG in Plasma in Part 2 | 15.238 Hours | Geometric Coefficient of Variation 21 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | T½ of DTG in Plasma in Part 2 | 14.690 Hours | Geometric Coefficient of Variation 18 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | T½ of DTG in Plasma in Part 2 | 14.741 Hours | Geometric Coefficient of Variation 23 |
Secondary
Terminal Elimination Phase Half-life (t½) of DTG in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Terminal Elimination Phase Half-life (t½) of DTG in Plasma in Part 1 | 14.300 Hours | Geometric Coefficient of Variation 21 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Terminal Elimination Phase Half-life (t½) of DTG in Plasma in Part 1 | 14.123 Hours | Geometric Coefficient of Variation 18 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Terminal Elimination Phase Half-life (t½) of DTG in Plasma in Part 1 | 14.008 Hours | Geometric Coefficient of Variation 20 |
Secondary
Time of Last Quantifiable Concentration (Tlast) of DTG in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Time of Last Quantifiable Concentration (Tlast) of DTG in Part 1 | 72.00 Hours |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Time of Last Quantifiable Concentration (Tlast) of DTG in Part 1 | 72.00 Hours |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Time of Last Quantifiable Concentration (Tlast) of DTG in Part 1 | 72.00 Hours |
Secondary
Time to Maximum Concentration (Tmax) of DTG in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Time to Maximum Concentration (Tmax) of DTG in Plasma in Part 1 | 3.00 Hours |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Time to Maximum Concentration (Tmax) of DTG in Plasma in Part 1 | 2.50 Hours |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Time to Maximum Concentration (Tmax) of DTG in Plasma in Part 1 | 3.00 Hours |
Secondary
Tlag of DTG in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Tlag of DTG in Plasma in Part 2 | 0.00 Hours |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Tlag of DTG in Plasma in Part 2 | 0.00 Hours |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Tlag of DTG in Plasma in Part 2 | 0.00 Hours |
Secondary
Tlast of 3TC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Tlast of 3TC in Plasma in Part 1 | 72.00 Hours |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Tlast of 3TC in Plasma in Part 1 | 72.00 Hours |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Tlast of 3TC in Plasma in Part 1 | 72.00 Hours |
Secondary
Tlast of 3TC in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Tlast of 3TC in Plasma in Part 2 | 72.00 Hours |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Tlast of 3TC in Plasma in Part 2 | 72.00 Hours |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Tlast of 3TC in Plasma in Part 2 | 72.00 Hours |
Secondary
Tlast of ABC in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Tlast of ABC in Part 1 | 24.00 Hours |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Tlast of ABC in Part 1 | 24.00 Hours |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Tlast of ABC in Part 1 | 24.00 Hours |
Secondary
Tlast of DTG in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Tlast of DTG in Plasma in Part 2 | 72.00 Hours |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Tlast of DTG in Plasma in Part 2 | 72.00 Hours |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Tlast of DTG in Plasma in Part 2 | 72.00 Hours |
Secondary
Tmax of 3TC in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Tmax of 3TC in Part 1 | 2.50 Hours |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Tmax of 3TC in Part 1 | 2.50 Hours |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Tmax of 3TC in Part 1 | 2.50 Hours |
Secondary
Tmax of 3TC in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Tmax of 3TC in Plasma in Part 2 | 1.00 Hours |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Tmax of 3TC in Plasma in Part 2 | 1.50 Hours |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Tmax of 3TC in Plasma in Part 2 | 1.50 Hours |
Secondary
Tmax of ABC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Tmax of ABC in Plasma in Part 1 | 1.50 Hours |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Tmax of ABC in Plasma in Part 1 | 1.00 Hours |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Tmax of ABC in Plasma in Part 1 | 1.00 Hours |
Secondary
Tmax of DTG in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Tmax of DTG in Plasma in Part 2 | 2.77 Hours |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Tmax of DTG in Plasma in Part 2 | 0.77 Hours |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Tmax of DTG in Plasma in Part 2 | 1.79 Hours |
Secondary
Vz/F of 3TC in Plasma in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Vz/F of 3TC in Plasma in Part 1 | 594.270 Liters | Geometric Coefficient of Variation 31 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Vz/F of 3TC in Plasma in Part 1 | 591.102 Liters | Geometric Coefficient of Variation 37 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Vz/F of 3TC in Plasma in Part 1 | 642.945 Liters | Geometric Coefficient of Variation 38 |
Secondary
Vz/F of 3TC in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Vz/F of 3TC in Plasma in Part 2 | 730.859 Liters | Geometric Coefficient of Variation 17 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Vz/F of 3TC in Plasma in Part 2 | 758.790 Liters | Geometric Coefficient of Variation 28 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Vz/F of 3TC in Plasma in Part 2 | 711.280 Liters | Geometric Coefficient of Variation 22 |
Secondary
Vz/F of ABC in Part 1
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Vz/F of ABC in Part 1 | 120.412 Liters | Geometric Coefficient of Variation 46 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Vz/F of ABC in Part 1 | 126.171 Liters | Geometric Coefficient of Variation 39 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Vz/F of ABC in Part 1 | 123.076 Liters | Geometric Coefficient of Variation 42 |
Secondary
Vz/F of DTG in Plasma in Part 2
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg Tablet | Vz/F of DTG in Plasma in Part 2 | 20.378 Liters | Geometric Coefficient of Variation 42 |
| DTG 5 mg/ABC 60 mg/3TC 30 mg Dispersible Tablets | Vz/F of DTG in Plasma in Part 2 | 11.950 Liters | Geometric Coefficient of Variation 28 |
| DTG 5 mg/ABC 60 mg/3TC 30mg Dispersible Tablet Direct to Mouth | Vz/F of DTG in Plasma in Part 2 | 15.524 Liters | Geometric Coefficient of Variation 30 |