Determinants of Warfarin Metabolism

NCT ID: NCT00162474

Last Updated: 2018-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Warfarin

Group Type EXPERIMENTAL

Warfarin

Intervention Type DRUG

Phenytoin

Intervention Type DRUG

Interventions

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Warfarin

Intervention Type DRUG

Phenytoin

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yoseph Caraco, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Yoseph Caraco, MD

Role: CONTACT

00 972 2 6778584

Facility Contacts

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Arik Tzukert, DMD

Role: primary

00 972 2 6776095

Hadas Lemberg, PhD

Role: backup

00 972 2 6777572

References

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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.

Reference Type DERIVED
PMID: 27878474 (View on PubMed)

Other Identifiers

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yc195510-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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