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NCT00975936 · ClinicalTrials.gov registry record · Phase 1
Phase 0 Microdose Study
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT00975936 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 12 participants.
The verdict
NCT00975936, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This study is a methodology study to evaluate a microdose strategy for Drug-Drug Interaction (DDI) which will be useful in the evaluation of the backup compounds for GSK706769, as well as possibly other assets. The safety, tolerability and pharmacokinetics will be evaluated in healthy adult subjects. This will be an open-label fixed-sequence 2-period study in healthy male volunteers after oral administration of \[14C\]-GSK706769 alone and in the presence of Ketoconazole.
Interventions
- DRUG Ketoconazole
- DRUG [14C]-GSK706769
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2009-09-21 |
| Est. Completion | 2009-11-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00975936
The ClinicalTrials.gov registry entry for NCT00975936 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ketoconazole is the first listed.
NCT00975936 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00975936 about?
NCT00975936 is a clinical study titled "Phase 0 Microdose Study". This study is a methodology study to evaluate a microdose strategy for Drug-Drug Interaction (DDI) which will be useful in the evaluation of the backup compounds for GSK706769, as well as possibly other assets. The safety, tolerability and pharmacokinetics will be evaluated in healthy adult subjects...
What is the current status of trial NCT00975936?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2009-09-21. Estimated completion is 2009-11-12.
What interventions are being tested in trial NCT00975936?
The interventions under investigation include: Ketoconazole (DRUG), [14C]-GSK706769 (DRUG).
Who is sponsoring clinical trial NCT00975936?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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