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NCT01648257 · ClinicalTrials.gov registry record · Phase 1
Relative Bioavailability Study of GSK1265744 Formulations
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01648257: Completed Phase 1 study, sponsored by ViiV Healthcare.
NCT01648257 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01648257, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This is a single-center, randomized, open-label, balanced, 3 way crossover study (3 periods) in healthy adult subjects. During each period, subjects will receive a single dose of GSK1265744 oral formulation in the fasted state and serial PK sampling for up to 168 hours (8 days) and safety assessments will be performed. Each period will be separated by a washout period of at least 14 days and a follow-up visit will occur 10 to 14 days after the last dose of study drug.
Primary Outcome
Plasma GSK1265744 PK parameters: area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time AUC(0-infinity); AUC from time zero to time t, AUC(0-t), and maximum observed concentration, Cmax.
Interventions
- DRUG GSK1265744 Na Salt Tablets
- DRUG GSK1265744 Free Acid Nanomilled Capsules
- DRUG GSK1265744 Free Acid Micronized Capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2012-08 |
| Est. Completion | 2012-11 |
| Phase | Phase 1 |
What the finished NCT01648257 record still lists
NCT01648257 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which GSK1265744 Na Salt Tablets is the first listed.
NCT01648257 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01648257 about?
NCT01648257 is a clinical study titled "Relative Bioavailability Study of GSK1265744 Formulations". This is a single-center, randomized, open-label, balanced, 3 way crossover study (3 periods) in healthy adult subjects. During each period, subjects will receive a single dose of GSK1265744 oral formulation in the fasted state and serial PK sampling for up to 168 hours (8 days) and safety assessment...
What is the current status of trial NCT01648257?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2012-08. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01648257?
The interventions under investigation include: GSK1265744 Na Salt Tablets (DRUG), GSK1265744 Free Acid Nanomilled Capsules (DRUG), GSK1265744 Free Acid Micronized Capsules (DRUG).
Who is sponsoring clinical trial NCT01648257?
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 NCT01648257's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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