Status:
COMPLETED
Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers
Lead Sponsor:
Biogen
Conditions:
Healthy
Eligibility:
All Genders
20-55 years
Phase:
PHASE1
Brief Summary
The primary objectives of the study are to evaluate the safety and tolerability of multiple doses of BIIB061 administered to healthy adults. The secondary objective is to determine the multiple-dose P...
Eligibility Criteria
Inclusion
- Key
- Males and postmenopausal (defined as no menses for 12 months and confirmed by follicle-stimulating hormone \[FSH\] levels determined at screening to be in the postmenopausal range) or surgically sterile females
- Must be in good health and have normal vital signs as determined by the Investigator, based on medical history and screening evaluations.
- Must agree to abstain from alcohol ingestion for the duration of the study.
- Must agree to abstain from consumption of grapefruit or grapefruit-containing products for the duration of the study, starting at least 24 hours prior to admission to the inpatient facility.
- Must agree to abstain from taking St. John's Wort (herbal preparation) for the duration of the study
- Must agree to abstain from any vigorous exercise (as determined by the Investigator) for the duration of the study.
- Must have a body mass index of 18 to 30 kg/m2, inclusive.
- Key
Exclusion
- History of or positive test result at screening for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\]).
- Presence of a metal device (e.g., any type of electronic, mechanical, or magnetic implant; cardiac pacemaker; aneurysm clips; implanted cardiac defibrillator) or potential ferromagnetic foreign body (metal slivers, metal shavings, other metal objects) that are contraindications for MRI.
- History of asthma, wheezing, allergies involving the lungs, or airway obstruction.
- History of bronchodilator or inhaler use.
- Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator.
- Inability or unwillingness to comply with study requirements.
- Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.
- Note: Other protocol defined inclusion/ exclusion criteria may apply.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT02228707
Start Date
August 1 2014
End Date
May 1 2016
Last Update
June 15 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Madison, Wisconsin, United States, 53704