Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BIIB061

Participants receive BIIB061

Group Type EXPERIMENTAL

BIIB061

Intervention Type DRUG

Participants receive BIIB061

Placebo

Participants receive matched placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Matched placebo

Interventions

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BIIB061

Participants receive BIIB061

Intervention Type DRUG

Placebo

Matched placebo

Intervention Type OTHER

Eligibility Criteria

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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.

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes