At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 41 enrolled
Drug / intervention
GSK3640254 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating GSK3640254, DTG, and 1 other intervention for HIV Infections. Completed, enrolled 41 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
Enrollment StartApr 2021
First PostedApr 2021
Primary CompletionSep 2021
TodayJul 2026
First PostedApr 23, 2021
Enrollment StartApr 21, 2021
Primary CompletionSep 10, 2021
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 5.2 years ago
Interventions
GSK3640254drug
GSK3640254 will be administered via oral route.
DTGdrug
DTG will be administered via oral route.
GSK3640254/DTGdrug
GSK3640254/DTG will be administered via oral route.