Drug-Drug Interaction Study Between Colchicine and Atorvastatin
Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
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.