N/A N=29 Basic Science

Pharmacogenetics of Warfarin Induction and Inhibition

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT01447511 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcome: Primary: Warfarin Clearance. — 282; 246; 180; 84 mL/h — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Control - Warfarin only (Drug); Fluconazole - Warfarin (Drug); Rifampin - Warfarin (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Jun 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Warfarin Clearance.	282; 246; 180; 84; 71; 136	<0.0001 sig

Summary

This research study will help determine how a person's genetic makeup affects their response to drugs, the ability of the body to break down drugs, and their potential to experience an interaction between drugs. The investigators are investigating the drug interactions with the commonly used anticoagulant drug called warfarin. Warfarin is used for the treatment and prevention of life-threatening abnormal blood clots such as deep vein thrombosis, heart attacks, and strokes. The investigators chose warfarin for this study because it is a commonly used drug and must be monitored closely to avoid side effects. The investigators are interested in studying whether individuals with certain genetic profiles react differently to warfarin when it is combined with other drugs. This research is being done to see if certain genetic profiles require us to adjust warfarin doses differently than is needed for the general population. Genetic profiles of subjects are determined from their participation in the Pharmacogenetics Registry study (investigator Richard Brundage, University of Minnesota). The study hypothesis is: Functionally defective CYP2C9 alleles attenuate the warfarin-fluconazole inhibitory interaction and exacerbate the warfarin-rifampin inductive interaction.

Eligibility Criteria

Inclusion Criteria

Subjects will be 18-60 years old.
Women of child bearing age must be willing to use measures to avoid conception during the study period.
Subjects must agree not to take any known substrates, inhibitors, inducers or activators of either CYP2C9 or CYP3A4 from 1 week prior to the start of each study through the last day of study.

Exclusion Criteria

Current cigarette smoker
Abnormal renal, liver function tests, physical exam, or recent history of hepatic, renal, gastrointestinal or neoplastic disease.
Allergy to warfarin, fluconazole or rifampin and other chemically related drugs.
Recent ingestion (< 1 week) of any medication known to be metabolized by or alter CYP2C9 or CYP3A4 activity.
A positive pregnancy test at the time of the pharmacokinetic study.
Lab tests indicative of abnormal blood clotting capacity.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01447511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.