Evaluation of CYP2C9 Activity

The Use of Phenytoin Metabolic Ratio as a Putative Marker of CYP2C9 Activity In-vivo

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00162461

Enrollment

1200

Registered

2005-09-13

Start date

1998-08-31

Completion date

2020-12-31

Last updated

2018-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy Volunteers

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

Interventions

DRUGPhenytoin single dose (300 mg)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Correlation between phenytoin metabolic ratio and CYP2C9 genotype	24 hours
Frequency distribution of phenytoin metabolic ratio in the population	24 hours

Countries

Israel

Contacts

Primary ContactYoseph Caraco, MD

caraco@hadassah.org.il00 972 2 6778584

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026