Status:
COMPLETED
Drug-Drug Interaction Between Colchicine and Ritonavir
Lead Sponsor:
Mutual Pharmaceutical Company, Inc.
Conditions:
Pharmacokinetics
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Ritonavir is a potent inhibitor of CYP3A4, one of the enzymes responsible for the metabolism of colchicine. This study will evaluate the effect of multiple doses of ritonavir on the pharmacokinetic pr...
Detailed Description
Ritonavir is a potent inhibitor of CYP3A4, one of the enzymes responsible for the metabolism of colchicine. This study will evaluate the effect of multiple doses of ritonavir on the pharmacokinetic pr...
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, hyperlipidemia, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurological, 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
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
NCT00983515
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
East Grand Forks, Minnesota, United States, 56721