NCT04857892

A Relative Bioavailability and Food-Effect Study of the Fixed Dose Combination of GSK3640254 and Dolutegravir (DTG) in Healthy Participants

A Two-Part, Randomized, Open-Label, Single Dose, Crossover Clinical Study to Assess the Relative Bioavailability of Fixed-Dose Combinations of GSK3640254 and Dolutegravir and to Assess the Effect of Food on the Select Fixed Dose Combination of GSK3640254 and Dolutegravir in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a two part study to compare the relative bioavailability (BA) of 2 fixed dose combinations (FDCs) of GSK3640254/DTG with GSK3640254 and DTG administered together as single agents (Part 1) and to assess the effect of food on the pharmacokinetic (PK) of the selected FDC of GSK3640254/DTG (Part 2).

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	GSK3640254	GSK3640254 will be administered via oral route.
DRUG	DTG	DTG will be administered via oral route.
DRUG	GSK3640254/DTG	GSK3640254/DTG will be administered via oral route.

Timeline

• Start date: 2021-04-21
• Primary completion: 2021-09-10
• Completion: 2021-09-10
• First posted: 2021-04-23
• Last updated: 2024-03-12
• Results posted: 2024-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study