BIIB014 Effects on the Pharmacokinetics (PK) of Rosiglitazone, Warfarin, and Midazolam

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-01

Study Completion Date

2010-06-02

Brief Summary

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The purpose of this study is to understand whether BIIB014 has potential to affect how certain drugs are broken down by the body.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Rosiglitazone 8mg PO

Cohort 1

Group Type EXPERIMENTAL

BIIB014

Intervention Type DRUG

BIIB014 100mg PO Cohort 1 - 8d Cohort 2 - 14d

Placebo

Intervention Type DRUG

Matched placebo to BIIB014 Cohort 1 - 8d Cohort 2 - 14d

Midazolam 2mg PO, Warfarin 25mg PO

Cohort 2

Group Type EXPERIMENTAL

BIIB014

Intervention Type DRUG

BIIB014 100mg PO Cohort 1 - 8d Cohort 2 - 14d

Placebo

Intervention Type DRUG

Matched placebo to BIIB014 Cohort 1 - 8d Cohort 2 - 14d

Interventions

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BIIB014

BIIB014 100mg PO Cohort 1 - 8d Cohort 2 - 14d

Intervention Type DRUG

Placebo

Matched placebo to BIIB014 Cohort 1 - 8d Cohort 2 - 14d

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female subjects
* Between the ages of 18 and 45, inclusive.
* Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive

Exclusion Criteria

* Clinically significant abnormalities (as determined by the Investigator)
* Other unspecified reason that would make the subject unsuitable for enrollment (as determined by the Investigator)

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes