Metabolic Capacity of Israeli Populations

This study has been terminated.

First Received: September 11, 2005 Last Updated: October 28, 2008 History of Changes

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

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

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Phenotypic and Genotypic Evaluation of Cytochrome P450 Isoforms in Populations of Different Ethnic Composition

Resource links provided by NLM:

MedlinePlus related topics: Caffeine

Drug Information available for: Mephenytoin Dapsone Debrisoquin sulfate Debrisoquin

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	yc19551-HMO-CTIL
Study First Received:	September 11, 2005
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00162383 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Study placed in the following topic categories:

Caffeine citrate
Mephenytoin
Neurotransmitter Agents
Adrenergic Agents
Debrisoquin
Dapsone

Caffeine
Peripheral Nervous System Agents
Cardiovascular Agents
Healthy
Antihypertensive Agents
Anticonvulsants

Additional relevant MeSH terms:

Sympatholytics
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Debrisoquin
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents

Pharmacologic Actions
Mephenytoin
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on September 11, 2009