Metabolic Capacity of Israeli Populations - Tabular View

Tracking Information

First Received Date ^ICMJE

September 11, 2005

Last Updated Date

October 28, 2008

Start Date ^ICMJE

July 1995

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

1. Phenotypic measurements of various P450 and non-P450 enzymes involved in drug metabolism
2. Frequency of genetic polymorphisms in these enzymes among different Israeli populations.

Change History

Complete list of historical versions of study NCT00162383 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Metabolic Capacity of Israeli Populations

Official Title ^ICMJE

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

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Condition ^ICMJE

Healthy Volunteers

Intervention ^ICMJE

Drug: Debrisoquine
Drug: Mephenytoin
Drug: Dapsone
Drug: Caffeine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

1200

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

20 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00162383

Responsible Party

Study ID Numbers ^ICMJE

yc19551-HMO-CTIL

Study Sponsor ^ICMJE

Hadassah Medical Organization

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Yoseph Caraco, MD

Hadassah Medical Organization

Information Provided By

Hadassah Medical Organization

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP