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NCT00983216 · ClinicalTrials.gov registry record · Phase 1
Drug-Drug Interaction Study Between Colchicine and Ketoconazole
A Phase 1 study of Pharmacokinetics, sponsored by Mutual Pharmaceutical Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT00983216: Completed Phase 1 study of Pharmacokinetics, sponsored by Mutual Pharmaceutical Company.
NCT00983216 is a Phase 1 study of Pharmacokinetics that has completed, run by Mutual Pharmaceutical Company. The registered enrollment target is 24 participants, below the 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00983216, a Phase 1 study of Pharmacokinetics, has completed, sponsored by Mutual Pharmaceutical Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Ketoconazole is a potent inhibitor of the cytochrome P450 (CYP) 3A4 enzyme system, one of the enzyme systems responsible for the metabolism of colchicine. This study will evaluate the effect of multiple doses of ketoconazole on the pharmacokinetic profile of a single 0.6 mg dose of colchicine. A secondary objective is to evaluate the safety and tolerability of this regimen in healthy volunteers. All study subjects will be monitored for adverse events throughout the study period.
Primary Outcome
The maximum or peak concentration that colchicine reaches in the plasma.
Conditions Studied
Interventions
- DRUG Colchicine
- DRUG Ketoconazole
Study Locations (1)
North Dakota
- PRACS Institute, Ltd. - Cetero Research - Fargo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2008-07 |
| Est. Completion | 2008-08 |
| Phase | Phase 1 |
What the finished NCT00983216 record still lists
NCT00983216 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 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Pharmacokinetics appearing as the primary indexed condition, and to 2 interventions - of which Colchicine is the first listed.
NCT00983216 reports a single indexed study location in North Dakota.
Frequently Asked Questions
What is clinical trial NCT00983216 about?
NCT00983216 is a clinical study titled "Drug-Drug Interaction Study Between Colchicine and Ketoconazole". Ketoconazole is a potent inhibitor of the cytochrome P450 (CYP) 3A4 enzyme system, one of the enzyme systems responsible for the metabolism of colchicine. This study will evaluate the effect of multiple doses of ketoconazole on the pharmacokinetic profile of a single 0.6 mg dose of colchicine. A sec...
What is the current status of trial NCT00983216?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2008-07. Estimated completion is 2008-08.
What conditions does trial NCT00983216 study?
This clinical trial studies the following conditions: Pharmacokinetics.
What interventions are being tested in trial NCT00983216?
The interventions under investigation include: Colchicine (DRUG), Ketoconazole (DRUG).
Who is sponsoring clinical trial NCT00983216?
This trial is sponsored by Mutual Pharmaceutical Company, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00983216 being conducted?
This trial has 1 study location across North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00983216's enrollment target sits among peer trials
24 23rd of 37 higher than 12 of 37 other Pharmacokinetics trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pharmacokinetics 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.
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