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NCT01648179 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Relative Bioavailability of Three Formulations and Food Effect on GSK1322322 in Healthy Subjects
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01648179: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT01648179 is a Phase 1 study that has completed, run by GlaxoSmithKline. 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
NCT01648179, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study is an open-label, randomized, single dose, four period, balanced crossover study to assess in eligible healthy male or female subjects.
Primary Outcome
GSK1322322 AUC(0-∞) and Cmax following wet milled tablet formulation administered with and without moderate fat/calorie meal. GSK1322322 AUC(0-∞) and Cmax following oral mesylate salt solution administration.
Interventions
- DRUG GSK1322322 (mesylate salt) Powder for Injection
- DRUG GSK1322322 (freebase) tablets
- DRUG GSK1322322 (mesylate salt) Powder for Oral Solution
- DRUG GSK1322322 (freebase) tablets FED
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-03 |
| Est. Completion | 2012-05 |
| Phase | Phase 1 |
What the finished NCT01648179 record still lists
NCT01648179 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 4 interventions - of which GSK1322322 (mesylate salt) Powder for Injection is the first listed.
NCT01648179 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01648179 about?
NCT01648179 is a clinical study titled "A Study to Assess the Relative Bioavailability of Three Formulations and Food Effect on GSK1322322 in Healthy Subjects". This study is an open-label, randomized, single dose, four period, balanced crossover study to assess in eligible healthy male or female subjects.
What is the current status of trial NCT01648179?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2012-03. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01648179?
The interventions under investigation include: GSK1322322 (mesylate salt) Powder for Injection (DRUG), GSK1322322 (freebase) tablets (DRUG), GSK1322322 (mesylate salt) Powder for Oral Solution (DRUG), GSK1322322 (freebase) tablets FED (DRUG).
Who is sponsoring clinical trial NCT01648179?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01648179'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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