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Metabolic Capacity of Israeli Populations

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ClinicalTrials.gov Identifier: NCT00162383
Recruitment Status : Recruiting
First Posted : September 13, 2005
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Yosef Caraco, Hadassah Medical Organization

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.


Condition or disease Intervention/treatment
Healthy Volunteers Drug: Debrisoquine Drug: Mephenytoin Drug: Dapsone Drug: Caffeine

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
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
Study Start Date : July 1995
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Cocktail Drug: Debrisoquine Drug: Mephenytoin Drug: Dapsone Drug: Caffeine



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


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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)

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

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 Posted: September 13, 2005    Key Record Dates
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
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Anticonvulsants