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

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ClinicalTrials.gov Identifier: NCT01017666
Recruitment Status : Completed
First Posted : November 20, 2009
Last Update Posted : September 17, 2010
Sponsor:
Information provided by:
Biogen

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: BIIB014 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (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
Study Start Date : November 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010


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




Primary Outcome Measures :
  1. 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 :
  1. Adverse Events [ Time Frame: Duration of subject participation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01017666


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

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
First Posted: November 20, 2009    Key Record Dates
Last Update Posted: September 17, 2010
Last Verified: September 2010

Keywords provided by Biogen:
Healthy Volunteer

Additional relevant MeSH terms:
Midazolam
3-(4-amino-3-methylbenzyl)-7-(2-furyl)-3H-(1,2,3)triazolo(4,5-d)pyrimidine-5-amine
Warfarin
Rosiglitazone
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Hypoglycemic Agents
Adenosine A2 Receptor Antagonists
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents