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NCT04857892 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by ViiV Healthcare.

Completed
Registry status
Phase 1
Development phase
41
Enrollment target

NCT04857892: Completed Phase 1 study, sponsored by ViiV Healthcare.

NCT04857892 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04857892, a Phase 1 study, has completed, sponsored by ViiV Healthcare.

COMPLETED
Registry status
Phase 1
Development phase
41 participants
Enrollment target

Study 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).

Primary Outcome

Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3640254.

Interventions

  • DRUG DTG
  • DRUG GSK3640254
  • DRUG GSK3640254/DTG

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2021-04-21
Est. Completion 2021-09-10
Phase Phase 1
ViiV Healthcare

182 total trials

What the finished NCT04857892 record still lists

NCT04857892 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).

The record links to 0 conditions, and to 3 interventions - of which DTG is the first listed.

NCT04857892 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04857892 about?

NCT04857892 is a clinical study titled "A Relative Bioavailability and Food-Effect Study of the Fixed Dose Combination of GSK3640254 and Dolutegravir (DTG) in Healthy Participants". 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...

What is the current status of trial NCT04857892?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2021-04-21. Estimated completion is 2021-09-10.

What interventions are being tested in trial NCT04857892?

The interventions under investigation include: DTG (DRUG), GSK3640254 (DRUG), GSK3640254/DTG (DRUG).

Who is sponsoring clinical trial NCT04857892?

This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04857892's enrollment target sits among peer trials

41 1125th of 2000 higher than 871 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04857892, the US trial registry maintained by the National Library of Medicine. NCT04857892 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.