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NCT04263142 · 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 of HIV Infections, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
- 1
- Study location
NCT04263142: Completed Phase 1 study of HIV Infections, sponsored by ViiV Healthcare.
NCT04263142 is a Phase 1 study of HIV Infections that has completed, run by ViiV Healthcare. The registered enrollment target is 39 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04263142, a Phase 1 study of HIV Infections, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label, 2 part, single-dose and crossover study conducted to assess the relative bioavailability of a tablet compared to a capsule of GSK3640254 and to assess the effect of food on the GSK3640254 tablet in healthy participants. This study will also evaluate the effect of food (fasted, moderate fat meal, and high fat meal) on the pharmacokinetics of the GSK3640254 mesylate tablet formulation. In Part 1, participants will be randomly assigned to 1 of 2 treatment sequences (AB or BA) in two sequential treatment periods; and in Part 2, participants will be randomly assigned to 1 of 3 treatment sequences (CDE, DEC, or ECD) in three sequential treatment periods. 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 30 participants will be enrolled.
Primary Outcome
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis. PK parameters were calculated using standard non-compartmental analysis.
Conditions Studied
Interventions
- DRUG GSK3640254 Tablet
- DRUG GSK3640254 Capsule
Study Locations (1)
Texas
- GSK Investigational Site - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2020-01-27 |
| Est. Completion | 2020-03-24 |
| Phase | Phase 1 |
What the finished NCT04263142 record still lists
NCT04263142 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (91% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which GSK3640254 Tablet is the first listed.
NCT04263142 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04263142 about?
NCT04263142 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, 2 part, single-dose and crossover study conducted to assess the relative bioavailability of a tablet compared to a capsule of GSK3640254 and to assess the effect of food on the GSK3640254 tablet in healthy participants. This study will also evaluate the effect of food (fasted,...
What is the current status of trial NCT04263142?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2020-01-27. Estimated completion is 2020-03-24.
What conditions does trial NCT04263142 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT04263142?
The interventions under investigation include: GSK3640254 Tablet (DRUG), GSK3640254 Capsule (DRUG).
Who is sponsoring clinical trial NCT04263142?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04263142 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04263142's enrollment target sits among peer trials
39 405th of 542 higher than 138 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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.
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