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

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ClinicalTrials.gov Identifier: NCT02228707
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : June 15, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: BIIB061 Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : August 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
Experimental: BIIB061
Participants receive BIIB061
Drug: BIIB061
Participants receive BIIB061

Placebo Comparator: Placebo
Participants receive matched placebo
Other: Placebo
Matched placebo




Primary Outcome Measures :
  1. Number of participants experiencing AEs [ Time Frame: Up to 28 days post treatment period (Day 1 to Day 56) ]

Secondary Outcome Measures :
  1. Plasma BIIB061 Concentration [ Time Frame: Up to 28 days post treatment period (Day 1 to Day 56) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228707


Locations
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United States, Wisconsin
Research Site
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen

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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02228707     History of Changes
Other Study ID Numbers: 231HV102
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016