Healthy Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 600 |
| Est. completion date | December 2020 |
| Est. primary completion date | December 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years to 50 Years |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Hadassah Medical Organization | Jerusalem |
| Lead Sponsor | Collaborator |
|---|---|
| Hadassah Medical Organization |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Warfarin oral clearance | 2 weeks | ||
| Primary | Formation clearance of CYP2C9 mediated warfarin metabolites | 2 weeks |
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