Metabolic Capacity of Israeli Populations

Phenotypic and Genotypic Evaluation of Cytochrome P450 Isoforms in Populations of Different Ethnic Composition

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Dapsone; Drug: Caffeine; Drug: Debrisoquine; Drug: Mephenytoin

• Study Type: Interventional
• Enrollment (Anticipated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yoseph Caraco, MD; Phone Number: 00 972 2 6778584; Email: caraco@hadassah.org.il

Study Locations

• Israel
  • Jerusalem, Israel
    • Recruiting
    • Hadassah Medical Organization
    • Principal Investigator: Yoseph Caraco, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cocktail	Drug: Dapsone; Drug: Caffeine; Drug: Debrisoquine; Drug: Mephenytoin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Phenotypic measurements of various P450 and non-P450 enzymes involved in drug metabolism.	24 hours
Frequency of genetic polymorphisms in these enzymes among different Israeli populations.	24 hours

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Investigators: Principal Investigator: Yoseph Caraco, MD, Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start: July 1, 1995
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: September 11, 2005
• First Submitted That Met QC Criteria: September 11, 2005
• First Posted (Estimate): September 13, 2005

Study Record Updates

• Last Update Posted (Actual): June 12, 2018
• Last Update Submitted That Met QC Criteria: June 11, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Anti-Bacterial Agents; Leprostatic Agents; Anticonvulsants; Antiprotozoal Agents; Antiparasitic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Antimalarials; Folic Acid Antagonists; Sympatholytics; Dapsone; Caffeine; Debrisoquin; Mephenytoin
• Other Study ID Numbers: yc19551-HMO-CTIL