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Cholesterol Metabolites as Markers for CYP3A Induction

NCT01340456 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-07-11

No results posted yet for this study

Summary

The objectives of this study are:

* To investigate if the endogenous cholesterol metabolite, 4beta-OHcholesterol could be used as a marker for induction of cytochrome P450 (CYP) 3A4.
* To compare 4beta-OHcholesterol with midazolam as a marker for induction of CYP3A4.

Conditions

  • CYP3A4 Induction

Interventions

DRUG

Rifampicin treatment

induction of CYP3A4 with one of three rifampicin doses (10, 20, 100 mg QD)

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Tobias Bäckström, MD PhD · Department of Clinical Pharmacology, Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01340456 on ClinicalTrials.gov