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NCT01031472 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess Relative Bioavailability and Food Effect of New Formulations of GSK2248761
A Phase 1 study of HIV Infections and Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01031472: Completed Phase 1 study of HIV Infections and Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare.
NCT01031472 is a Phase 1 study of HIV Infections and Infection, Human Immunodeficiency Virus that has completed, run by ViiV Healthcare. The registered enrollment target is 24 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01031472, a Phase 1 study of HIV Infections and Infection, Human Immunodeficiency Virus, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-center, randomized, two part, open-label, crossover study in healthy adult subjects to assess the effect of up to three formulations on the relative bioavailability of GSK2248761 100mg administered with and without food. Part A will evaluate two new formulations compared to the current formulation. Part B will evaluate one additional formulation if the bioavailability of the two formulations in Part A do not meet pre-specified criteria. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 7-10 days after the last dose of study drug.
Primary Outcome
Plasma samples will be collected for the analysis of AUC (0-inf) of GSK2248761.
Conditions Studied
Interventions
- DRUG GSK2248761 formulation 1
- DRUG GSK2248761 reference formulation
- DRUG GSK2248761 formulation 3
- DRUG GSK2248761 formulation 2 or 4
Study Locations (1)
New York
- GSK Investigational Site - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2009-12-21 |
| Est. Completion | 2010-03-11 |
| Phase | Phase 1 |
What the finished NCT01031472 record still lists
NCT01031472 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 4 interventions - of which GSK2248761 formulation 1 is the first listed.
NCT01031472 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01031472 about?
NCT01031472 is a clinical study titled "A Study to Assess Relative Bioavailability and Food Effect of New Formulations of GSK2248761". This is a single-center, randomized, two part, open-label, crossover study in healthy adult subjects to assess the effect of up to three formulations on the relative bioavailability of GSK2248761 100mg administered with and without food. Part A will evaluate two new formulations compared to the curr...
What is the current status of trial NCT01031472?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2009-12-21. Estimated completion is 2010-03-11.
What conditions does trial NCT01031472 study?
This clinical trial studies the following conditions: HIV Infections, Infection, Human Immunodeficiency Virus.
What interventions are being tested in trial NCT01031472?
The interventions under investigation include: GSK2248761 formulation 1 (DRUG), GSK2248761 reference formulation (DRUG), GSK2248761 formulation 3 (DRUG), GSK2248761 formulation 2 or 4 (DRUG).
Who is sponsoring clinical trial NCT01031472?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01031472 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01031472's enrollment target sits among peer trials
24 470th of 542 higher than 64 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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