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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01031472
The ClinicalTrials.gov registry entry for NCT01031472 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (95% lower). The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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