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Metabolic Capacity of Israeli Populations

This study is currently recruiting participants.
Verified March 2017 by Yosef Caraco, Hadassah Medical Organization
Sponsor:
ClinicalTrials.gov Identifier:
NCT00162383
First Posted: September 13, 2005
Last Update Posted: March 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Yosef Caraco, Hadassah Medical Organization
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Phenotypic and Genotypic Evaluation of Cytochrome P450 Isoforms in Populations of Different Ethnic Composition

Further study details as provided by Yosef Caraco, Hadassah Medical Organization:

Primary Outcome Measures:
  • Phenotypic measurements of various P450 and non-P450 enzymes involved in drug metabolism. [ Time Frame: 24 hours ]
  • Frequency of genetic polymorphisms in these enzymes among different Israeli populations. [ Time Frame: 24 hours ]

Estimated Enrollment: 1200
Study Start Date: July 1995
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cocktail Drug: Debrisoquine Drug: Mephenytoin Drug: Dapsone Drug: Caffeine

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162383


Contacts
Contact: Yoseph Caraco, MD 00 972 2 6778584 caraco@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Yoseph Caraco, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Yoseph Caraco, MD Hadassah Medical Organization
  More Information

Responsible Party: Yosef Caraco, Head, Clinical Pharmacology Unit, Division of Medicine, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00162383     History of Changes
Other Study ID Numbers: yc19551-HMO-CTIL
First Submitted: September 11, 2005
First Posted: September 13, 2005
Last Update Posted: March 6, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Caffeine
Dapsone
Debrisoquin
Mephenytoin
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Leprostatic Agents
Anti-Bacterial Agents
Anticonvulsants
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents