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NCT01098513 · ClinicalTrials.gov registry record · Phase 1
GSK1349572 Relative Bioavailability Study
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01098513: Completed Phase 1 study, sponsored by ViiV Healthcare.
NCT01098513 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01098513, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a single-center, randomized, two part, open-label, crossover study in healthy adult subjects. Part A will evaluate the relative bioavailability of two new tablet formulations compared to the current tablet formulation of GSK1349572 at 50 mg administered as single doses each comprising of two 25 mg tablets. Pharmacokinetic samples from Part A will be analyzed and, if at least one of the new formulations meets appropriate criteria and is selected, Part B will be a single-sequence design conducted to evaluate food effect of the selected new tablet formulation at one dose level. A subset of subjects enrolled in Part A will continue in Part B. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 7-28 days after the last dose of study drug.
Interventions
- DRUG GSK1349572 formulation AP
- DRUG GSK1349572 formulation AW
- DRUG GSK1349572 formulation AX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-04 |
| Est. Completion | 2010-07 |
| Phase | Phase 1 |
What the finished NCT01098513 record still lists
NCT01098513 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 3 interventions - of which GSK1349572 formulation AP is the first listed.
NCT01098513 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01098513 about?
NCT01098513 is a clinical study titled "GSK1349572 Relative Bioavailability Study". This is a single-center, randomized, two part, open-label, crossover study in healthy adult subjects. Part A will evaluate the relative bioavailability of two new tablet formulations compared to the current tablet formulation of GSK1349572 at 50 mg administered as single doses each comprising of two...
What is the current status of trial NCT01098513?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2010-04. Estimated completion is 2010-07.
What interventions are being tested in trial NCT01098513?
The interventions under investigation include: GSK1349572 formulation AP (DRUG), GSK1349572 formulation AW (DRUG), GSK1349572 formulation AX (DRUG).
Who is sponsoring clinical trial NCT01098513?
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 NCT01098513's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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