Evaluation of CYP2C9 Activity

Not Applicable

• Conditions: Healthy
• Interventions: Drug: Phenytoin single dose (300 mg)

• Registration Number: NCT00162461
• Lead Sponsor: Hadassah Medical Organization

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 1998-08
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-13
• Status Verified: 2018-03
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-06-12
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phenytoin	Phenytoin single dose (300 mg)	-

Primary Outcome Measures

Name	Time	Method
Frequency distribution of phenytoin metabolic ratio in the population	24 hours
Correlation between phenytoin metabolic ratio and CYP2C9 genotype	24 hours

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel