Determinants of Warfarin Metabolism
Information source: Hadassah Medical Organization
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Warfarin (Drug); Phenytoin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Hadassah Medical Organization Official(s) and/or principal investigator(s):
Yoseph Caraco, MD, Principal Investigator, Affiliation: Hadassah Medical Organization
Overall contact:
Yoseph Caraco, MD, Phone: 00 972 2 6778584, Email: caraco@hadassah.org.il
Summary
The anticoagulant effect of warfarin varies greatly among individuals. Some of this
variability is attributed to differences in the activity of CYP2C9, the predominant enzyme
involved in the metabolism of S-warfarin.
The present study is designed to define the differences in warfarin metabolism among healthy
individuals carrying different CYP2C9 genotypes. In addition, the study will define the
correlation between the phenytoin metabolic ratio, a marker of CYP2C9 activity in vivo, and
warfarin metabolism.
Clinical Details
Official title: Correlation Between Phenotypic Activity of CYP2C9 and Genetic Polymorphism in CYP2C9 and Warfarin Metabolism.
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Warfarin oral clearanceFormation clearance of CYP2C9 mediated warfarin metabolites
Eligibility
Minimum age: 20 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age range of 20-50 years old
- The absence of significant disease states
Exclusion Criteria:
- Known hypersensitivity to warfarin or phenytoin
- The presence of significant disease states
- Regular use of drugs (including birth control pills)
Locations and Contacts
Yoseph Caraco, MD, Phone: 00 972 2 6778584, Email: caraco@hadassah.org.il
Hadassah Medical Organization, Jerusalem, Israel; Recruiting
Arik Tzukert, DMD, Phone: 00 972 2 6776095, Email: arik@hadassah.org.il
Hadas Lemberg, PhD, Phone: 00 972 2 6777572, Email: lhadas@hadassah.org.il
Yoseph Caraco, MD, Principal Investigator
Additional Information
Starting date: September 2003
Last updated: October 28, 2008
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