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

This study has been completed.
Information provided by:
Biogen Identifier:
First received: November 16, 2009
Last updated: September 16, 2010
Last verified: September 2010
The purpose of this study is to understand whether BIIB014 has potential to affect how certain drugs are broken down by the body.

Condition Intervention Phase
Drug: BIIB014
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Biogen:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Adverse Events [ Time Frame: Duration of subject participation ]

Enrollment: 28
Study Start Date: November 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01017666

United Kingdom
InCROM Clinical Research Unit
London, United Kingdom, E14NL
Sponsors and Collaborators
  More Information

Responsible Party: Clinical Trial Manager, Biogen Idec Ltd Identifier: NCT01017666     History of Changes
Other Study ID Numbers: 204HV103
EUDRA CT 2009-014259-60
Study First Received: November 16, 2009
Last Updated: September 16, 2010

Keywords provided by Biogen:
Healthy Volunteer

Additional relevant MeSH terms:
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Adenosine A2 Receptor Antagonists
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents processed this record on May 24, 2017