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NCT00162461 Clinical Trial

Evaluation of CYP2C9 Activity

Healthy Clinical Trial

Official title:
The Use of Phenytoin Metabolic Ratio as a Putative Marker of CYP2C9 Activity In-vivo

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00162461
Other study ID # yc19559-HMO-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1998
Est. completion date December 2020

Study information
Verified date March 2018
Source Hadassah Medical Organization
Contact Yoseph Caraco, MD
Phone 00 972 2 6778584
Email caraco@hadassah.org.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The use of phenytoin metabolism to produce S-HPPH accounts for more than 85% of its metabolism. This metabolic pathway is mediated by the activity of CYP2C9.

The purpose of the present study is:

1. To confirm the use of phenytoin metabolic ratio as a marker of CYP2C9 activity

2. To correlate phenytoin metabolic ratio with CYP2C9 genotype

3. To study the frequency distribution of CYP2C9 activity in-vivo

Recruitment information / eligibility
Status Recruiting
Enrollment 1200
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

- Absence of significant disease states

Exclusion Criteria:

- The presence of significant disease states

- The use of drugs (including birth control pills)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Phenytoin single dose (300 mg)

Locations
Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (2)
Lead Sponsor Collaborator
Hadassah Medical Organization United States - Israel Binational Science Foundation

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation between phenytoin metabolic ratio and CYP2C9 genotype 24 hours
Primary Frequency distribution of phenytoin metabolic ratio in the population 24 hours
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