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Trial record 23 of 107 for:    PHENYTOIN

Evaluation of CYP2C9 Activity

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ClinicalTrials.gov Identifier: NCT00162461
Recruitment Status : Recruiting
First Posted : September 13, 2005
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
United States - Israel Binational Science Foundation
Information provided by (Responsible Party):
Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE September 11, 2005
First Posted Date  ICMJE September 13, 2005
Last Update Posted Date June 12, 2018
Study Start Date  ICMJE August 1998
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2017)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2005)
  • 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  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of CYP2C9 Activity
Official Title  ICMJE 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:

  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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Phenytoin single dose (300 mg)
Study Arms  ICMJE Experimental: Phenytoin
Intervention: Drug: Phenytoin single dose (300 mg)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 3, 2017)
1200
Original Enrollment  ICMJE
 (submitted: September 11, 2005)
600
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Yoseph Caraco, MD 00 972 2 6778584 caraco@hadassah.org.il
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00162461
Other Study ID Numbers  ICMJE yc19559-HMO-CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Hadassah Medical Organization
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE United States - Israel Binational Science Foundation
Investigators  ICMJE
Principal Investigator: Yoseph Caraco, MD Hadassah Medical Organization
PRS Account Hadassah Medical Organization
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP