Drug-Drug Interaction Study Between Colchicine and Ketoconazole
Status:
Completed
Trial end date:
2008-08-01
Target enrollment:
Participant gender:
Summary
Ketoconazole is a potent inhibitor of the cytochrome P450 (CYP) 3A4 enzyme system, one of the
enzyme systems responsible for the metabolism of colchicine. This study will evaluate the
effect of multiple doses of ketoconazole 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.