Drug-Drug Interaction Study of Colchicine and Clarithromycin

Phase 1 Completed 24 enrolled Mutual Pharmaceutical Company, Inc.

Non-randomizedSingle-groupOpen-labelBasic science

Summary

Clarithromycin is a potent inhibitor of the activity of cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp). CYP 3A4 plays a role in the metabolism of colchicine and P-gp is responsible for the efflux of colchicine across membranes. This study will evaluate the effect of clarithromycin-related inhibition of CYP 3A4 and P-gp on the pharmacokinetics of colchicine. It will also evaluate the safety and tolerability of concurrent administration of clarithromycin and a single dose of colchicine.

Timeline

Start: 2007-11
Primary completion: 2007-12
Completion: 2008-01

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	Clarithromycin	Small molecule	250 mg	—
Subject	Colchicine	Small molecule	0.6 mg	—

Indications

No indication recorded.