Evaluation of CYP2C9 Activity - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 11, 2005

Last Updated Date

October 28, 2008

Start Date ^†

August 1998

Current Primary Outcome Measures ^†

Correlation between phenytoin metabolic ratio and CYP2C9 genotype
Frequency distribution of phenytoin metabolic ratio in the population

Original Primary Outcome Measures ^†

Correlation between phenytoin metabolic ratio and CYP2C9 genotype
Frequency distribution of phenytoin metabolic ratio in the population

Change History

Complete list of historical versions of study NCT00162461 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Evaluation of CYP2C9 Activity

Official Title ^†

The Use of Phenytoin Metabolic Ratio as a Putative Marker of CYP2C9 Activity in-Vivo

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:

To confirm the use of phenytoin metabolic ratio as a marker of CYP2C9 activity
To correlate phenytoin metabolic ratio with CYP2C9 genotype
To study the frequency distribution of CYP2C9 activity in-vivo

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Condition ^†

Healthy

Intervention ^†

Drug: Phenytoin single dose (300 mg)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

600

Completion Date

Primary Completion Date

Eligibility Criteria ^†

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)

Gender

Both

Ages

20 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Yoseph Caraco, MD

00 972 2 6778584

caraco@hadassah.org.il

Location Countries ^†

Israel

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00162461

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Hadassah Medical Organization

Collaborators ^††

United States - Israel Binational Science Foundation

Investigators ^†

Principal Investigator:

Yoseph Caraco, MD

Hadassah Medical Organization

Information Provided By

Hadassah Medical Organization

Verification Date

October 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.