This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Metabolic Capacity of Israeli Populations

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Yosef Caraco, Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Yosef Caraco, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00162383
First received: September 11, 2005
Last updated: March 3, 2017
Last verified: March 2017
  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: No masking
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 11, 2005
Last Updated: March 3, 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

ClinicalTrials.gov processed this record on June 23, 2017