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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Other: Placebo; Drug: BIIB061

• Registration Number: NCT02228707
• Lead Sponsor: Biogen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-27
• Study First Submitted QC: 2014-08-27
• Study First Posted: 2014-08-29
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-14
• Last Update Posted: 2016-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants receive matched placebo
BIIB061	BIIB061	Participants receive BIIB061

Primary Outcome Measures

Name	Time	Method
Number of participants experiencing AEs	Up to 28 days post treatment period (Day 1 to Day 56)

Secondary Outcome Measures

Name	Time	Method
Plasma BIIB061 Concentration	Up to 28 days post treatment period (Day 1 to Day 56)

Trial Locations

Locations (1)

Research Site; 🇺🇸 Madison, Wisconsin, United States