Genetic Variability in the Response to Warfarin at Baseline and During Induction of CYP2C9

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2011 by Hadassah Medical Organization
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01388075
First received: July 3, 2011
Last updated: July 5, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Healthy Subjects
Drug: Rifampicin

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • International Normalized Ratio (INR) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Warfarin concentration [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2011
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rifampicin
Consecutive treatments with rifampicin and placebo
Drug: Rifampicin
oral, 450 mg/day , 7 days

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects

Exclusion Criteria:

  • Consumption of any medication during 30 days
  • Smoking
  • Alcohol consumption
  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: NCT01388075

Contacts
Contact: Mordechai Muszkat, MD 972-6777111 ext 73793 muszkatm@hadassah.org.il

Locations
Israel
Hadassah Hebrew University Medical Center Not yet recruiting
Jerusalem, Israel, 91120
Contact: Mordechai Muszkat, MD    972-2-6777111 ext 73793    muszkatm@hadassah.org.il   
Principal Investigator: Mordechai Muszkat, MD         
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Mordechai Muszkat, MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01388075     History of Changes
Other Study ID Numbers: HMO-0451-10
Study First Received: July 3, 2011
Last Updated: July 5, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
induction
CYP2C9
Genetic variability
Expression

Additional relevant MeSH terms:
Rifampin
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014