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Evaluation of CYP2C9 Activity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
United States - Israel Binational Science Foundation
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00162461
First received: September 11, 2005
Last updated: October 28, 2008
Last verified: October 2008
History of Changes
  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:

  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

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

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

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Hadassah Medical Organization:
Healthy Volunteers

Additional relevant MeSH terms:
Phenytoin
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013