Clinical trial NCT02228707: Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2014-08-29
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 PK profile of BIIB061 in this study population.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants experiencing AEs
timeFrame: Up to 28 days post treatment period (Day 1 to Day 56)
Secondary outcomes:
measure: Plasma BIIB061 Concentration
timeFrame: Up to 28 days post treatment period (Day 1 to Day 56)
Other outcomes:
Locations:
city: Madison
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: