Drug-Drug Interaction Study of Colchicine and Azithromycin

Phase 1 Completed 24 enrolled Mutual Pharmaceutical Company, Inc.

Non-randomizedCrossoverOpen-labelBasic science

Summary

Azithromycin is a possible weak to moderate inhibitor of CYP3A4, one of the enzymes responsible for the metabolism of colchicine. This study will evaluate the effect of multiple doses of azithromycin 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	Azithromycin	Small molecule	250 mg	Oral
Subject	Colchicine	Small molecule	0.6 mg	Oral

Indications

No indication recorded.