Overview

Drug-Drug Interaction Study Between Colchicine and Cyclosporine

Status:
Completed
Trial end date:
2008-09-01
Target enrollment:
Participant gender:
Summary
Colchicine is a substrate for both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp). Cyclosporine is a potent inhibitor of both CYP3A4 and P-gp. This study will evaluate the effect of single-dose cyclosporine 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
Phase:
Phase 1
Details
Lead Sponsor:
Mutual Pharmaceutical Company, Inc.
Treatments:
Colchicine
Cyclosporine
Cyclosporins