Drug-Drug Interaction Study Between Colchicine and Atorvastatin

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.

Timeline

Start

2009-02

Primary completion

2009-03

Completion

2009-03

Publications

• Davis MW, Wason S. Effect of steady-state atorvastatin on the pharmacokinetics of a single dose of colchicine in healthy adults under fasted conditions. Clin Drug Investig. 2014 Apr;34(4):259-67. doi: 10.1007/s40261-013-0168-8.

Drugs

Indications

No indication recorded.