Evaluation of CYP2C9 Activity

This study is currently recruiting participants.

Verified by Hadassah Medical Organization, October 2008

Sponsors and Collaborators:	Hadassah Medical Organization United States - Israel Binational Science Foundation
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00162461

Purpose

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

Condition	Intervention
Healthy	Drug: Phenytoin single dose (300 mg)

Drug Information available for: Phenytoin Phenytoin sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	The Use of Phenytoin Metabolic Ratio as a Putative Marker of CYP2C9 Activity in-Vivo

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

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

Estimated Enrollment:	600
Study Start Date:	August 1998

Eligibility

Ages Eligible for Study:	20 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162461

Contacts

Contact: Yoseph Caraco, MD

00 972 2 6778584

caraco@hadassah.org.il

Locations

Israel
Hadassah Medical Organization	Recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD 00 972 2 6776095 arik@hadassah.org.il
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il
Principal Investigator: Yoseph Caraco, MD

Sponsors and Collaborators

Hadassah Medical Organization

United States - Israel Binational Science Foundation

Investigators

Principal Investigator:

Yoseph Caraco, MD

Hadassah Medical Organization

More Information

Study ID Numbers:	yc19559-HMO-CTIL
Study First Received:	September 11, 2005
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00162461
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

Healthy Volunteers

Study placed in the following topic categories:

Phenytoin
Healthy

Additional relevant MeSH terms:

Therapeutic Uses
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 15, 2009