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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 is a Phase 1 study that was terminated before completion, run by ViiV Healthcare. The registered enrollment target is 16 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04128293
The ClinicalTrials.gov registry entry for NCT04128293 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which GSK3640254 Tablet is the first listed.
NCT04128293 reports 0 study locations.
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.
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