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NCT00501397 · ClinicalTrials.gov registry record · Phase 1
A Study of the Effects of Ketoconazole Taken Orally Has on the PK Profiles of a Dose of GSK189075 in Healthy Volunteers
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT00501397: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT00501397 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00501397, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
The purpose of this research study is to evaluate the effect of several daily doses of ketoconazole (a medication used to treat fungal infections like athlete's foot) on a single dose of GSK189075 (an experimental diabetes drug), and also to evaluate the safety and tolerability of GSK189075 in healthy volunteers. The study will see whether ketoconazole causes GSK189075 to stay in your bloodstream for a longer period of time. It will also examine whether GSK189075 causes any changes in the amount of glucose you have in your urine.
Interventions
- DRUG GSK189075
- DRUG ketoconazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2007-02 |
| Phase | Phase 1 |
What the finished NCT00501397 record still lists
NCT00501397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which GSK189075 is the first listed.
NCT00501397 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00501397 about?
NCT00501397 is a clinical study titled "A Study of the Effects of Ketoconazole Taken Orally Has on the PK Profiles of a Dose of GSK189075 in Healthy Volunteers". The purpose of this research study is to evaluate the effect of several daily doses of ketoconazole (a medication used to treat fungal infections like athlete's foot) on a single dose of GSK189075 (an experimental diabetes drug), and also to evaluate the safety and tolerability of GSK189075 in healt...
What is the current status of trial NCT00501397?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2007-02.
What interventions are being tested in trial NCT00501397?
The interventions under investigation include: GSK189075 (DRUG), ketoconazole (DRUG).
Who is sponsoring clinical trial NCT00501397?
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 NCT00501397's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 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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