Drug-Drug Interaction Study Between Colchicine and Cyclosporine

Phase 1 Completed 24 enrolled Mutual Pharmaceutical Company, Inc.

Non-randomizedSingle-groupOpen-labelBasic science

Summary

Colchicine is a substrate for both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp). Cyclosporine is a potent inhibitor of both CYP3A4 and P-gp. This study will evaluate the effect of single-dose cyclosporine 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: 2008-08
Primary completion: 2008-09
Completion: 2008-09

Publications

Wason S, Digiacinto JL, Davis MW. Effect of cyclosporine on the pharmacokinetics of colchicine in healthy subjects. Postgrad Med. 2012 Jul;124(4):189-96. doi: 10.3810/pgm.2012.07.2579.
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	Cyclosporine	Peptide	100 mg	Oral

Indications

No indication recorded.