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Determinants of Warfarin Metabolism

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Yosef Caraco, Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Yosef Caraco, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00162474
First received: September 11, 2005
Last updated: March 3, 2017
Last verified: March 2017

September 11, 2005
March 3, 2017
September 2003
December 2020   (Final data collection date for primary outcome measure)
  • Warfarin oral clearance [ Time Frame: 2 weeks ]
  • Formation clearance of CYP2C9 mediated warfarin metabolites [ Time Frame: 2 weeks ]
  • Warfarin oral clearance
  • Formation clearance of CYP2C9 mediated warfarin metabolites
Complete list of historical versions of study NCT00162474 on ClinicalTrials.gov 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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Interventional
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Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Other
Healthy
  • Drug: Warfarin
  • Drug: Phenytoin
Experimental: Warfarin
Interventions:
  • Drug: Warfarin
  • Drug: Phenytoin
Shaul C, Blotnick S, Muszkat M, Bialer M, Caraco Y. Quantitative Assessment of CYP2C9 Genetic Polymorphisms Effect on the Oral Clearance of S-Warfarin in Healthy Subjects. Mol Diagn Ther. 2017 Feb;21(1):75-83. doi: 10.1007/s40291-016-0247-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
December 2020
December 2020   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
20 Years to 50 Years   (Adult)
Yes
Contact: Yoseph Caraco, MD 00 972 2 6778584 caraco@hadassah.org.il
Israel
 
 
NCT00162474
yc195510-HMO-CTIL
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Yosef Caraco, Hadassah Medical Organization
Hadassah Medical Organization
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Principal Investigator: Yoseph Caraco, MD Hadassah Medical Organization
Hadassah Medical Organization
March 2017

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