Metabolic Capacity of Israeli Populations - Full Text View

Purpose

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.

Condition	Intervention
Healthy Volunteers	Drug: Debrisoquine Drug: Mephenytoin Drug: Dapsone Drug: Caffeine

MedlinePlus related topics:

Caffeine

ChemIDplus related topics:

Dapsone 3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione Caffeine citrate Debrisoquin Debrisoquin sulfate Mephenytoin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

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

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

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

Estimated Enrollment:	1200
Study Start Date:	July 1995

Eligibility

Ages Eligible for Study:	20 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162383

Locations


Israel
	Hadassah Medical Organization
	Jerusalem, Israel

Sponsors and Collaborators

Hadassah Medical Organization

Investigators


Principal Investigator:	Yoseph Caraco, MD	Hadassah Medical Organization

More Information

Study ID Numbers:	yc19551-HMO-CTIL
First Received:	September 11, 2005
Last Updated:	March 17, 2008
ClinicalTrials.gov Identifier:	NCT00162383
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Study placed in the following topic categories:

Caffeine citrate

Mephenytoin

Debrisoquin

Dapsone

Caffeine

Healthy

Additional relevant MeSH terms:

Sympatholytics

Neurotransmitter Agents

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Central Nervous System Agents

Anticonvulsants

ClinicalTrials.gov processed this record on September 19, 2008

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00162383