BIIB014 Effects on the Pharmacokinetics (PK) of Rosiglitazone, Warfarin, and Midazolam
- Registration Number
- NCT01017666
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Rosiglitazone 8mg PO BIIB014 Cohort 1 Rosiglitazone 8mg PO Placebo Cohort 1 Midazolam 2mg PO, Warfarin 25mg PO BIIB014 Cohort 2 Midazolam 2mg PO, Warfarin 25mg PO Placebo Cohort 2
- Primary Outcome Measures
Name Time Method Pharmacokinetic profile of rosiglitazone (Cohort 1), midazolam & metabolites and s-warfarin (Cohort 2) during steady state exposure to BIIB014 or placebo 24 hours (Cohort 1); 144 hours (Cohort 2)
- Secondary Outcome Measures
Name Time Method Adverse Events Duration of subject participation
Trial Locations
- Locations (1)
InCROM Clinical Research Unit
🇬🇧London, United Kingdom