To Assess the Relative Bioavailability (BA) of TRIUMEQ® and Dolutegravir and Lamivudine (DTG/3TC) Pediatric Dispersible Tablet Formulations in Healthy Volunteers
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

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.
    


Intervention name(s): Treatment A; Treatment B; Treatment C; Treatment D; Treatment E; Treatment F
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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.; TRIUMEQ (Pediatric) administered as a, single dose, FDC tablet - DTG 5 mg/ABC 60 mg/ 3TC 30 mg, orally as 10 dispersible tablets; TRIUMEQ (Pediatric) administered as a, single dose, FDC tablet - DTG 5 mg/ABC 60 mg/3TC 30 mg, orally as direct-to-mouth.; 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.; 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.; 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.
Allocation: Randomized
Intervention model: Crossover Assignment
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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric dispersible tablets; Bioavailability