drugset / Trial / NCT01250535
Human Cytochrome P450 4F Enzymes and Drug Interactions
Phase 1
Completed
19 enrolled
University of North Carolina, Chapel Hill
National Institutes of Health (NIH) · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lovastatin | Small molecule | 40 mg | Oral |
| Subject | Warfarin | Small molecule | 10 mg | Oral |
Indications
No indication recorded.