Clinical trial

A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Assess the Effect of BIIB014 on the Pharmacokinetics of Rosiglitazone, Warfarin, and Midazolam in Healthy Volunteers

Name

204HV103

Description

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

Trial arms

Trial start

2009-11-01

Estimated PCD

2010-06-02

Trial end

2010-06-02

Status

Completed

Phase

Early phase I

Treatment

BIIB014

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

Arms:

Midazolam 2mg PO, Warfarin 25mg PO, Rosiglitazone 8mg PO

Placebo

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

Arms:

Midazolam 2mg PO, Warfarin 25mg PO, Rosiglitazone 8mg PO

Size

Primary endpoint

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

24 hours (Cohort 1); 144 hours (Cohort 2)

Eligibility criteria

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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 28, 'type': 'ACTUAL'}}

Updated at

2023-08-23

1 organization

2 products

1 indication

Product

Indication

Organization

Product