NCT04827134

A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants

A Randomized, 2-Cohort, 2-Period, Single Dose, Crossover Clinical Study to Assess the Effect of Food on the Pediatric Dispersible Tablet Formulations of TRIUMEQ (Dolutegravir/Abacavir/Lamivudine) and DOVATO (Dolutegravir/Lamivudine) in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study will assess the effect of food on the pharmacokinetics (PK) of pediatric formulations of TRIUMEQ (dolutegravir \[DTG\] 5 milligrams \[mg\]/abacavir \[ABC\] 60 mg/lamivudine \[3TC\] 30 mg) dispersible tablets and DOVATO (DTG 5 mg/3TC 30 mg) dispersible tablets in healthy adult participants. Additionally, safety and tolerability of these formulations will also be assessed. TRIUMEQ and DOVATO are registered trademarks of GlaxoSmithKline group of companies.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	TRIUMEQ	TRIUMEQ will be available as fixed dose combination (FDC) dispersible tablets to be administered orally as a dispersion.
DRUG	DOVATO	DOVATO will be available as FDC dispersible tablets to be administered orally as a dispersion.

Timeline

• Start date: 2021-05-07
• Primary completion: 2021-07-23
• Completion: 2021-07-23
• First posted: 2021-04-01
• Last updated: 2023-06-05
• Results posted: 2023-06-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study