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Human Cytochrome P450 4F Enzymes and Drug Interactions

NCT01250535 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2013-01-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Michael Z Wang, PhD · University of Kansas

  • Kim LR Brouwer, PharmD PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01250535 on ClinicalTrials.gov