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NCT00162383 Clinical Trial

Metabolic Capacity of Israeli Populations

Healthy Volunteers Clinical Trial

Official title:
Phenotypic and Genotypic Evaluation of Cytochrome P450 Isoforms in Populations of Different Ethnic Composition

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00162383
Other study ID # yc19551-HMO-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1995
Est. completion date December 2020

Study information
Verified date March 2018
Source Hadassah Medical Organization
Contact Yoseph Caraco, MD
Phone 00 972 2 6778584
Email caraco@hadassah.org.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1200
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Debrisoquine

• Mephenytoin

• Dapsone

• Caffeine

Locations
Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Phenotypic measurements of various P450 and non-P450 enzymes involved in drug metabolism. 24 hours
Primary Frequency of genetic polymorphisms in these enzymes among different Israeli populations. 24 hours
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