Determinants of Warfarin Metabolism

• Sponsor: Hadassah Medical Organization (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00162474
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Arm: 1
• Duration (Months): 207
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Warfarin; Drug: Phenytoin	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 600 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Correlation Between Phenotypic Activity of CYP2C9 and Genetic Polymorphism in CYP2C9 and Warfarin Metabolism.
• Study Start Date: Sep 1, 2003
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Warfarin	Drug: Warfarin; Drug: Phenytoin

Outcome Measures

Primary Outcome Measures

1. Warfarin oral clearance [2 weeks]

2. Formation clearance of CYP2C9 mediated warfarin metabolites [2 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Medical Organization	Jerusalem		Israel

Sponsors and Collaborators

• Hadassah Medical Organization

Investigators

• Principal Investigator: Yoseph Caraco, MD, Hadassah Medical Organization

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hadassah Medical Organization
• ClinicalTrials.gov Identifier: NCT00162474
• Other Study ID Numbers: yc195510-HMO-CTIL
• First Posted: Sep 13, 2005
• Last Update Posted: Jun 12, 2018
• Last Verified: Mar 1, 2018

• Keywords provided by Hadassah Medical Organization: Healthy Volunteers
• Additional relevant MeSH terms: Phenytoin; Warfarin

Study Results

No Results Posted as of Jun 12, 2018