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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

November 16, 2009
September 16, 2010
November 2009
June 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01017666 on ClinicalTrials.gov Archive Site
Adverse Events [ Time Frame: Duration of subject participation ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Healthy
  • Drug: BIIB014
    BIIB014 100mg PO Cohort 1 - 8d Cohort 2 - 14d
  • Drug: Placebo
    Matched placebo to BIIB014 Cohort 1 - 8d Cohort 2 - 14d
  • Experimental: Rosiglitazone 8mg PO
    Cohort 1
    Interventions:
    • Drug: BIIB014
    • Drug: Placebo
  • Experimental: Midazolam 2mg PO, Warfarin 25mg PO
    Cohort 2
    Interventions:
    • Drug: BIIB014
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
June 2010
June 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01017666
204HV103, EUDRA CT 2009-014259-60
No
Clinical Trial Manager, Biogen Idec Ltd
Biogen Idec
Not Provided
Not Provided
Biogen Idec
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP