Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Determinants of Warfarin Metabolism

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Information provided by:
Hadassah Medical Organization Identifier:
First received: September 11, 2005
Last updated: October 28, 2008
Last verified: October 2008

September 11, 2005
October 28, 2008
September 2003
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  • Warfarin oral clearance
  • Formation clearance of CYP2C9 mediated warfarin metabolites
Same as current
Complete list of historical versions of study NCT00162474 on Archive Site
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Determinants of Warfarin Metabolism
Correlation Between Phenotypic Activity of CYP2C9 and Genetic Polymorphism in CYP2C9 and Warfarin Metabolism.

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.

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Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Drug: Warfarin
  • Drug: Phenytoin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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)
20 Years to 50 Years
Contact: Yoseph Caraco, MD 00 972 2 6778584
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Hadassah Medical Organization
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Principal Investigator: Yoseph Caraco, MD Hadassah Medical Organization
Hadassah Medical Organization
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP