Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 20 - 55 |
| Updated: | 6/16/2016 |
| Start Date: | August 2014 |
| End Date: | May 2016 |
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers
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 PK profile of BIIB061 in this study population.
doses of BIIB061 administered to healthy adults. The secondary objective is to determine the
multiple-dose PK profile of BIIB061 in this study population.
Key Inclusion Criteria:
- 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 Criteria:
- 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.
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