Evaluation of CYP2C9 Activity

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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...

Brief Summary

Official Title: “The Use of Phenytoin Metabolic Ratio as a Putative Marker of CYP2C9 Activity in-Vivo”

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

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Intervention(s) in this Clinical Trial

  • Drug: Phenytoin single dose (300 mg)

Outcome Measures for this Clinical Trial

Primary Measures

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

Criteria for Participation in this Clinical Trial

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: Hadassah Medical Organization Other

Overall Clinical Trial Officials and Contacts

Yoseph Caraco, MD Principal Investigator Hadassah Medical Organization  

Overall Contact: Yoseph Caraco, MD 00 972 2 6778584 caraco@hadassah.org.il

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00162461

Study ID Number: yc19559-HMO-CTIL

ClinicalTrials.gov Identifier: NCT00162461

Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00162461