Phase 1
Completed N=24
Drug-Drug Interaction Study Between Colchicine and Atorvastatin
Healthy
Source: ClinicalTrials.gov NCT00960323 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Mar 2010
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) of Colchicine — 2,023.29; 2,487.96 pg/mL
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) of Colchicine |
2,023.29; 2,487.96 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] |
8,717.33; 10,714.92 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] |
9,592.53; 11,043.58 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT00960323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.