Metabolic Capacity of Israeli Populations

Not Applicable

• Conditions: Healthy Volunteers
• Interventions: Drug: Debrisoquine; Drug: Mephenytoin; Drug: Dapsone; Drug: Caffeine

• Registration Number: NCT00162383
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

The ability to metabolize drugs varies greatly among individuals. Major fraction of this variability lies in genetic polymorphisms of genes encoding for enzymes responsible for both phase I and phase II reactions.

The purpose of this study ws to evaluate the phenotypic activity and the frequency of genetic polymorphisms in different phase II and phase I enzymes among various populations residing in Israel.

Detailed Description

Not available

Study Timeline

• Study Start: 1995-07
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-13
• Status Verified: 2018-03
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-06-12
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Age range 20-50
• Absence of significant disease state

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cocktail	Mephenytoin	-
Cocktail	Caffeine	-
Cocktail	Debrisoquine	-
Cocktail	Dapsone	-

Primary Outcome Measures

Name	Time	Method
Phenotypic measurements of various P450 and non-P450 enzymes involved in drug metabolism.	24 hours
Frequency of genetic polymorphisms in these enzymes among different Israeli populations.	24 hours

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel