Metabolic Capacity of Israeli Populations

This study has been terminated.

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

Sponsor:	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:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label
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 3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione 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

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

Additional relevant MeSH terms:

Caffeine
Mephenytoin
Dapsone
Debrisoquin
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents

Neurotransmitter Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Leprostatic Agents
Anti-Bacterial Agents
Antihypertensive Agents
Cardiovascular Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 12, 2012