- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01388075
Genetic Variability in the Response to Warfarin at Baseline and During Induction of CYP2C9
July 5, 2011 updated by: Hadassah Medical Organization
The genetic factors associated with variability in CYP2C9 induction have not been elucidated.
The hypothesis underlying this study is that following 7 days treatment with rifampicin, a known CYP450 inducer, the genetic variability in regulatory elements controlling CYP2C9 expression will be associated with the magnitude of change in INR response to warfarin and in CYP2C9-mediated warfarin metabolism.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mordechai Muszkat, MD
- Phone Number: 73793 972-6777111
- Email: muszkatm@hadassah.org.il
Study Locations
-
-
-
Jerusalem, Israel, 91120
- Hadassah Hebrew University Medical Center
-
Principal Investigator:
- Mordechai Muszkat, MD
-
Contact:
- Mordechai Muszkat, MD
- Phone Number: 73793 972-2-6777111
- Email: muszkatm@hadassah.org.il
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy subjects
Exclusion Criteria:
- Consumption of any medication during 30 days
- Smoking
- Alcohol consumption
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rifampicin
Consecutive treatments with rifampicin and placebo
|
oral, 450 mg/day , 7 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
International Normalized Ratio (INR)
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Warfarin concentration
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Anticipated)
June 1, 2018
Study Registration Dates
First Submitted
July 3, 2011
First Submitted That Met QC Criteria
July 5, 2011
First Posted (Estimate)
July 6, 2011
Study Record Updates
Last Update Posted (Estimate)
July 6, 2011
Last Update Submitted That Met QC Criteria
July 5, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Antitubercular Agents
- Antibiotics, Antitubercular
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C8 Inducers
- Cytochrome P-450 CYP2C19 Inducers
- Cytochrome P-450 CYP2C9 Inducers
- Rifampin
Other Study ID Numbers
- HMO-0451-10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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