NCT00162461

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. 1.To confirm the use of phenytoin metabolic ratio as a marker of CYP2C9 activity
  2. 2.To correlate phenytoin metabolic ratio with CYP2C9 genotype
  3. 3.To study the frequency distribution of CYP2C9 activity in-vivo

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Aug 1998

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1998

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
15.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 12, 2018

Status Verified

March 1, 2018

Enrollment Period

22.4 years

First QC Date

September 11, 2005

Last Update Submit

June 11, 2018

Conditions

Healthy

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Correlation between phenytoin metabolic ratio and CYP2C9 genotype

    24 hours

  • Frequency distribution of phenytoin metabolic ratio in the population

    24 hours

Study Arms (1)

Phenytoin

EXPERIMENTAL
Drug: Phenytoin single dose (300 mg)

Interventions

Phenytoin single dose (300 mg)DRUG
Phenytoin

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age range of 20-50 years old
  • Absence of significant disease states

You may not qualify if:

  • The presence of significant disease states
  • The use of drugs (including birth control pills)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

RECRUITING

MeSH Terms

Interventions

Phenytoin

Intervention Hierarchy (Ancestors)

HydantoinsImidazolidinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Yoseph Caraco, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoseph Caraco, MD

CONTACT

00 972 2 6778584caraco@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 13, 2005

Study Start

August 1, 1998

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

June 12, 2018

Record last verified: 2018-03

Locations

IL(1)