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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01017666
First received: November 16, 2009
Last updated: September 16, 2010
Last verified: September 2010
History of Changes
  Purpose

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
Healthy
 Drug: BIIB014
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Further study details as provided by Biogen Idec:

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: Duration of subject participation ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017666

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

No publications provided

Responsible Party: Clinical Trial Manager, Biogen Idec Ltd
ClinicalTrials.gov 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
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Biogen Idec:
Healthy Volunteer

Additional relevant MeSH terms:
Midazolam
Warfarin
Rosiglitazone
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
 Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Hematologic Agents
Hypoglycemic Agents

ClinicalTrials.gov processed this record on May 23, 2013