At a glance
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A One-Directional, Open-Label Drug Interaction Study to Investigate the Effects of Multiple-Dose Atorvastatin on the Single-Dose Pharmacokinetics of Colchicine in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Colchicine and Atorvastatin for Healthy. Completed, enrolled 24 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
A single dose of 0.6 mg colchicine administered alone in the morning on Day 1.
Atorvastatin (1 x 40 mg tablet) administered once daily on Days 15-28.
A single dose of 0.6 mg colchicine administered with a single dose of 40 mg atorvastatin in the morning on Day 28 after an overnight fast.