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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01017666

Enrollment

Registered

2009-11-20

Start date

2009-11-01

Completion date

2010-06-02

Last updated

2023-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy Volunteer

Brief summary

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

Interventions

DRUGBIIB014

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
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)

Secondary

Measure	Time frame
Adverse Events	Duration of subject participation

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026