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

Biogen28 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

BIIB014DRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

InCROM Clinical Research Unit

London, United Kingdom

Outcomes

Primary Outcomes

Pharmacokinetic profile of rosiglitazone (Cohort 1), midazolam & metabolites and s-warfarin (Cohort 2) during steady state exposure to BIIB014 or placebo

Time frame: 24 hours (Cohort 1); 144 hours (Cohort 2)

Secondary Outcomes

Adverse Events

Time frame: Duration of subject participation

Data from ClinicalTrials.gov

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