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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00983216
The ClinicalTrials.gov registry entry for NCT00983216 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (61% lower). The listed sponsor is Mutual Pharmaceutical Company, which has 27 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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