NCT01250535

Human Cytochrome P450 4F Enzymes and Drug Interactions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers
• Drug Drug Interactions

Interventions

Type	Name	Description
DRUG	Warfarin	10 mg, po, single dose on day 7
DRUG	Placebo	po, once a day, days 1 through 14
DRUG	Lovastatin	40 mg, po, once a day, days 1 through 14

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-11-30
• Last updated: 2013-01-21

Locations

1 site across 1 country: United States