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NCT00984061 · ClinicalTrials.gov registry record · Phase 1
Drug-Drug Interaction Study of Colchicine and Clarithromycin
A Phase 1 study, sponsored by Mutual Pharmaceutical Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00984061: Completed Phase 1 study, sponsored by Mutual Pharmaceutical Company.
NCT00984061 is a Phase 1 study that has completed, run by Mutual Pharmaceutical Company. 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
NCT00984061, a Phase 1 study, has completed, sponsored by Mutual Pharmaceutical Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Clarithromycin is a potent inhibitor of the activity of cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp). CYP 3A4 plays a role in the metabolism of colchicine and P-gp is responsible for the efflux of colchicine across membranes. This study will evaluate the effect of clarithromycin-related inhibition of CYP 3A4 and P-gp on the pharmacokinetics of colchicine. It will also evaluate the safety and tolerability of concurrent administration of clarithromycin and a single dose of colchicine.
Primary Outcome
The maximum or peak concentration that colchicine reaches in the plasma.
Interventions
- DRUG clarithromycin
- DRUG colchicine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2007-11 |
| Est. Completion | 2008-01 |
| Phase | Phase 1 |
What the finished NCT00984061 record still lists
NCT00984061 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 2 interventions - of which clarithromycin is the first listed.
NCT00984061 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00984061 about?
NCT00984061 is a clinical study titled "Drug-Drug Interaction Study of Colchicine and Clarithromycin". Clarithromycin is a potent inhibitor of the activity of cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp). CYP 3A4 plays a role in the metabolism of colchicine and P-gp is responsible for the efflux of colchicine across membranes. This study will evaluate the effect of clarithromycin-related inhib...
What is the current status of trial NCT00984061?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2007-11. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00984061?
The interventions under investigation include: clarithromycin (DRUG), colchicine (DRUG).
Who is sponsoring clinical trial NCT00984061?
This trial is sponsored by Mutual Pharmaceutical Company, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00984061'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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