NCT01388075

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 6, 2011

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Last Updated

July 6, 2011

Status Verified

July 1, 2011

Enrollment Period

6.9 years

First QC Date

July 3, 2011

Last Update Submit

July 5, 2011

Conditions

Healthy Subjects

Keywords

inductionCYP2C9Genetic variabilityExpression

Outcome Measures

Primary Outcomes (1)

  • International Normalized Ratio (INR)

    6 weeks

Secondary Outcomes (1)

  • Warfarin concentration

    6 weeks

Study Arms (1)

Rifampicin

EXPERIMENTAL

Consecutive treatments with rifampicin and placebo

Drug: Rifampicin

Interventions

RifampicinDRUG

oral, 450 mg/day , 7 days

Rifampicin

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Hebrew University Medical Center

Jerusalem, 91120, Israel

Location

MeSH Terms

Interventions

Rifampin

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Central Study Contacts

Mordechai Muszkat, MD

CONTACT

972-6777111muszkatm@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 3, 2011

First Posted

July 6, 2011

Study Start

July 1, 2011

Primary Completion

June 1, 2018

Last Updated

July 6, 2011

Record last verified: 2011-07

Locations

IL(1)