Drug-Drug Interaction Study Between Colchicine and Ketoconazole

Phase 1 Completed 24 enrolled Mutual Pharmaceutical Company, Inc.

Non-randomizedSingle-groupOpen-labelBasic science

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.

Timeline

Start: 2008-07
Primary completion: 2008-08
Completion: 2008-08

Publications

Terkeltaub RA, Furst DE, Digiacinto JL, Kook KA, Davis MW. Novel evidence-based colchicine dose-reduction algorithm to predict and prevent colchicine toxicity in the presence of cytochrome P450 3A4/P-glycoprotein inhibitors. Arthritis Rheum. 2011 Aug;63(8):2226-37. doi: 10.1002/art.30389.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Colchicine	Small molecule	0.6 mg	Oral
Subject	Ketoconazole	Small molecule	200 mg	—

Indications

No indication recorded.