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NCT01627587 · ClinicalTrials.gov registry record · Phase 1
A Two Cohort Study to Look at the Metabolites of GSK221149, the Metabolism of GSK221149 Administered With a High Fat Meal and With Ketoconazole
A Phase 1 study of Obstetric Labour, Premature, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT01627587: Completed Phase 1 study of Obstetric Labour, Premature, sponsored by GlaxoSmithKline.
NCT01627587 is a Phase 1 study of Obstetric Labour, Premature that has completed, run by GlaxoSmithKline. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01627587, a Phase 1 study of Obstetric Labour, Premature, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a two part study. Part A of the study will evaluate the metabolites of GSK221149 following single and repeat oral dosing and will also assess the pharmacokinetics of GSK221149 when administered with a potent CYP3A4 inhibitor Ketoconazole. Part B of the study will look at the pharmacokinetics of GSK221149 following a high fat meal.
Conditions Studied
Interventions
- DRUG Ketoconazole
- DRUG GSK221149 750 mg
- DRUG GSK221149 100 mg
- DRUG GSK221149 750 mg Fasted
- DRUG GSK221149 750 mg + Food
Study Locations (1)
Texas
- GSK Investigational Site - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2011-12-12 |
| Est. Completion | 2012-02-09 |
| Phase | Phase 1 |
What the finished NCT01627587 record still lists
NCT01627587 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 1 condition, with Obstetric Labour, Premature appearing as the primary indexed condition, and to 5 interventions - of which Ketoconazole is the first listed.
NCT01627587 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01627587 about?
NCT01627587 is a clinical study titled "A Two Cohort Study to Look at the Metabolites of GSK221149, the Metabolism of GSK221149 Administered With a High Fat Meal and With Ketoconazole". This is a two part study. Part A of the study will evaluate the metabolites of GSK221149 following single and repeat oral dosing and will also assess the pharmacokinetics of GSK221149 when administered with a potent CYP3A4 inhibitor Ketoconazole. Part B of the study will look at the pharmacokinetics...
What is the current status of trial NCT01627587?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2011-12-12. Estimated completion is 2012-02-09.
What conditions does trial NCT01627587 study?
This clinical trial studies the following conditions: Obstetric Labour, Premature.
What interventions are being tested in trial NCT01627587?
The interventions under investigation include: Ketoconazole (DRUG), GSK221149 750 mg (DRUG), GSK221149 100 mg (DRUG), GSK221149 750 mg Fasted (DRUG), GSK221149 750 mg + Food (DRUG).
Who is sponsoring clinical trial NCT01627587?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01627587 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obstetric Labour, Premature
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01627587's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 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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