Drug-Drug Interaction Study Between Colchicine and Atorvastatin
Completed · Phase 1
Conditions studied: Healthy
In brief
Colchicine is a substrate for cytochrome P450 3A4 (CYP3A4). In-vitro studies have indicated that the ortho-and para-hydroxylated metabolites of atorvastatin may be CYP3A4/5 competitive and mechanism-based inhibitors (MBI). This study will evaluate the effect of multiple doses of atorvastatin 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.
Key facts
- Study ID
- NCT00960323
- Run by
- Mutual Pharmaceutical Company, Inc.
- People needed
- 24
- Starts
- 2009-02-01
- Expected to finish
- 2009-03-01
- Last updated by the study team
- 2010-03-30
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy adults 18-45 years of age
- Non-smoking and non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures)
- Body mass index (BMI) greater than or equal to 18 and less than or equal to 32, inclusive
- Hemoglobin greater than or equal to 11.5g/dL
You may not qualify if…
- 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 atorvastatin or any other HMG-CoA reductase inhibitor agents (i.e. simvastatin, lovastatin, rosuvastatin, fluvastatin, and pravastatin)
Where it is running
- PRACS Institute, Ltd. - Cetero Research — Fargo, North Dakota, United States
Full record on ClinicalTrials.gov
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