Drug-Drug Interaction Between Colchicine and Ritonavir

Phase 1 Completed 24 enrolled Mutual Pharmaceutical Company, Inc.

Non-randomizedSingle-groupOpen-labelBasic science

Summary

Ritonavir is a potent inhibitor of CYP3A4, one of the enzymes responsible for the metabolism of colchicine. This study will evaluate the effect of multiple doses of ritonavir 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	Ritonavir	Other / unclassified	100 mg	—

Indications

No indication recorded.