Status:
COMPLETED
Drug-Drug Interaction Study Between Colchicine and Ketoconazole
Lead Sponsor:
Mutual Pharmaceutical Company, Inc.
Conditions:
Pharmacokinetics
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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 multip...
Detailed Description
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 multip...
Eligibility Criteria
Inclusion
- Healthy adults 18-45 years of age, non-smoking and non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures) with a body mass index (BMI) greater than or equal to 18 and less than or equal to 32, inclusive
Exclusion
- Recent participation (within 28 days) in other research studies
- Recent significant blood donation or plasma donation
- Pregnant or lactating
- Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
- Recent (2-year) history or evidence of alcoholism or drug abuse
- History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
- Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study
- Drug allergies to colchicine or ketoconazole or any other anti-fungal agent
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00983216
Start Date
July 1 2008
End Date
August 1 2008
Last Update
October 15 2009
Active Locations (1)
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1
PRACS Institute, Ltd. - Cetero Research
Fargo, North Dakota, United States, 58104