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NCT04128293 · ClinicalTrials.gov registry record · Phase 1
A Relative Bioavailability and Food-Effect Study of GSK3640254 Tablet and Capsule Formulations in Healthy Participants
A Phase 1 study, sponsored by ViiV Healthcare.
- Terminated
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT04128293: Clinical Trial Phase 1 study, sponsored by ViiV Healthcare.
NCT04128293 is a Phase 1 study that was terminated before completion, run by ViiV Healthcare. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04128293, a Phase 1 study, was terminated before completion, sponsored by ViiV Healthcare.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This is an open-label, single-dose, four-period, four sequential, and crossover study conducted to assess the relative bioavailability of GSK3640254 mesylate tablets and GSK3640254 mesylate capsules (in the presence of a moderate fat meal). This study will also evaluate the effect of food (fasted, moderate fat meal, and high fat meal) on the pharmacokinetics of GSK3640254 mesylate tablet formulation. Participants will be randomized to receive a single dose of GSK3640254 200 milligram (mg) capsules under moderate fat conditions and GSK3640254 200 mg tablets under moderate fat, fasted and high fat conditions in each treatment period. Approximately 16 participants will be enrolled and the duration of the study will be approximately 54 days.
Primary Outcome
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. PK Parameter Population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated.
Interventions
- DRUG GSK3640254 Tablet
- DRUG GSK3640254 Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-10-08 |
| Est. Completion | 2019-11-15 |
| Phase | Phase 1 |
Why NCT04128293 stopped before completion
NCT04128293 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which GSK3640254 Tablet is the first listed.
NCT04128293 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04128293 about?
NCT04128293 is a clinical study titled "A Relative Bioavailability and Food-Effect Study of GSK3640254 Tablet and Capsule Formulations in Healthy Participants". This is an open-label, single-dose, four-period, four sequential, and crossover study conducted to assess the relative bioavailability of GSK3640254 mesylate tablets and GSK3640254 mesylate capsules (in the presence of a moderate fat meal). This study will also evaluate the effect of food (fasted, m...
What is the current status of trial NCT04128293?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2019-10-08. Estimated completion is 2019-11-15.
What interventions are being tested in trial NCT04128293?
The interventions under investigation include: GSK3640254 Tablet (DRUG), GSK3640254 Capsule (DRUG).
Who is sponsoring clinical trial NCT04128293?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04128293's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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