Evaluation of CYP2C9 Activity

Condition(s) targeted: Healthy

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

Phase: N/A

Status: Recruiting

Sponsored by: Hadassah Medical Organization

Official(s) and/or principal investigator(s):
Yoseph Caraco, MD, Principal Investigator, Affiliation: Hadassah Medical Organization

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

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

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

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome:

Correlation between phenytoin metabolic ratio and CYP2C9 genotype

Frequency distribution of phenytoin metabolic ratio in the population

Minimum age: 20 Years. Maximum age: 50 Years. Gender(s): Both.

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)

Yoseph Caraco, MD, Phone: 00 972 2 6778584, Email: caraco@hadassah.org.il

Hadassah Medical Organization, Jerusalem, Israel; Recruiting
Arik Tzukert, DMD, Phone: 00 972 2 6776095, Email: arik@hadassah.org.il
Hadas Lemberg, PhD, Phone: 00 972 2 6777572, Email: lhadas@hadassah.org.il
Yoseph Caraco, MD, Principal Investigator

Starting date: August 1998
Last updated: October 28, 2008