drugset / Trial / NCT01250535

Human Cytochrome P450 4F Enzymes and Drug Interactions

NCT01250535

RandomizedCrossoverTriple-blindBasic science

Summary

Drug-drug interactions play an important role in clinical adverse events due to the prevalence of multi-drug therapy. Co-administration of warfarin and a statin has expanded substantially in the US over the last decades. The purpose of this study is to develop a mechanistic understanding of the role of a drug-metabolizing enzyme, CYP4F2, in the interaction between warfarin and statins. This study will test the hypothesis that lovastatin potentiates the anticoagulant effect of warfarin by inducing vitamin K-metabolizing enzyme CYP4F2 in humans, thus increasing warfarin's anticoagulant effect.

Timeline

Start
2010-12
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Lovastatin Small molecule 40 mg Oral
Subject Warfarin Small molecule 10 mg Oral

Indications

No indication recorded.