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

August 21, 2023 updated by: Biogen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, E14NL
        • InCROM Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rosiglitazone 8mg PO
Cohort 1
Drug: BIIB014
BIIB014 100mg PO Cohort 1 - 8d Cohort 2 - 14d
Drug: Placebo
Matched placebo to BIIB014 Cohort 1 - 8d Cohort 2 - 14d
Experimental: Midazolam 2mg PO, Warfarin 25mg PO
Cohort 2
Drug: BIIB014
BIIB014 100mg PO Cohort 1 - 8d Cohort 2 - 14d
Drug: Placebo
Matched placebo to BIIB014 Cohort 1 - 8d Cohort 2 - 14d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
24 hours (Cohort 1); 144 hours (Cohort 2)

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: Duration of subject participation
Duration of subject participation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2009

Primary Completion (Actual)

June 2, 2010

Study Completion (Actual)

June 2, 2010

Study Registration Dates

First Submitted

November 16, 2009

First Submitted That Met QC Criteria

November 19, 2009

First Posted (Estimated)

November 20, 2009

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 21, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 204HV103
  • EUDRA CT 2009-014259-60

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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