NCT00162383

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Jul 1995

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1995

Completed
10.2 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
15.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 12, 2018

Status Verified

March 1, 2018

Enrollment Period

25.4 years

First QC Date

September 11, 2005

Last Update Submit

June 11, 2018

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Cocktail

EXPERIMENTAL
Drug: DebrisoquineDrug: MephenytoinDrug: DapsoneDrug: Caffeine

Interventions

DebrisoquineDRUG
Cocktail
MephenytoinDRUG
Cocktail
DapsoneDRUG
Cocktail
CaffeineDRUG
Cocktail

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age range 20-50
  • Absence of significant disease state

You may not qualify if:

  • The presence of significant disease states
  • The regular use of drugs (including birth control pills)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

RECRUITING

MeSH Terms

Interventions

DebrisoquinMephenytoinDapsoneCaffeine

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHydantoinsImidazolidinesImidazolesAzolesHeterocyclic Compounds, 1-RingSulfonesSulfur CompoundsOrganic ChemicalsXanthinesAlkaloidsPurinonesPurines

Study Officials

  • Yoseph Caraco, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoseph Caraco, MD

CONTACT

00 972 2 6778584caraco@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 13, 2005

Study Start

July 1, 1995

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

June 12, 2018

Record last verified: 2018-03

Locations

IL(1)