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Evaluation of CYP2C9 Activity

This study is currently recruiting participants.
Verified March 2017 by Yosef Caraco, Hadassah Medical Organization
Sponsor:
ClinicalTrials.gov Identifier:
NCT00162461
First Posted: September 13, 2005
Last Update Posted: March 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
United States - Israel Binational Science Foundation
Information provided by (Responsible Party):
Yosef Caraco, Hadassah Medical Organization
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Use of Phenytoin Metabolic Ratio as a Putative Marker of CYP2C9 Activity In-vivo

Resource links provided by NLM:


Further study details as provided by Yosef Caraco, Hadassah Medical Organization:

Primary Outcome Measures:
  • Correlation between phenytoin metabolic ratio and CYP2C9 genotype [ Time Frame: 24 hours ]
  • Frequency distribution of phenytoin metabolic ratio in the population [ Time Frame: 24 hours ]

Estimated Enrollment: 1200
Study Start Date: August 1998
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phenytoin Drug: Phenytoin single dose (300 mg)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Yosef Caraco, Head, Clinical Pharmacology Unit, Division of Medicine, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00162461     History of Changes
Other Study ID Numbers: yc19559-HMO-CTIL
First Submitted: September 11, 2005
First Posted: September 13, 2005
Last Update Posted: March 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Yosef Caraco, Hadassah Medical Organization:
Healthy Volunteers

Additional relevant MeSH terms:
Phenytoin
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers