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COMPLETED Phase 1

Drug-Drug Interaction Study Between Colchicine and Ketoconazole

NCT00983216 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 24 participants
Start Date 2008-07
Est. Completion 2008-08
Phase Phase 1

Sponsor

Mutual Pharmaceutical Company

4 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mutual Pharmaceutical Company, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00983216 reports 1 study location spanning 1 distinct geographic area — top geographies include North Dakota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00983216?

The interventions under investigation include: Colchicine (DRUG), Ketoconazole (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00983216?

This trial is sponsored by Mutual Pharmaceutical Company, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial