Back to resultsSingle-Dose Study of a New Formulation of BIIB061
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BIIB061
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Oral Remyelination
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.
- All male subjects must practice effective contraception during the study and be willing and able to continue male contraception for 3 months after the dose of study treatment. All male subjects must also be willing to refrain from sperm donation for at least 3 months after their dose of study treatment.
- Must be in good health and have normal vital signs as determined by the Investigator, based on medical history and screening evaluations.
- Body mass index of 18.0 to 30.0 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]).
- Prior exposure to BIIB061.
- History of any clinically significant cardiac, endrocrinologic, hematologic, hepatic, gastric, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, oncologic, or other major disease, as determined by the Investigator.
- Treatment with any prescription medication within 28 days prior to and throughout the duration of the study.
- Use of any over-the-counter products, including herbal or alternative health preparations within the 14 days prior to the study
- Enrollment in any interventional clinical study in which an investigational drug, biologic, device, or approved therapy for investigational use is administered or used within 30 days prior to the study
- Any live or attenuated immunization/vaccination given within 30 days prior to the study or planned to be given during the study.
- Blood donation within 30 days prior to the study
- Surgery within 3 months prior to the study
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BIIB061
Arm Description
Single oral dose of 30 mg BIIB061 of the new formulation
Outcomes
Primary Outcome Measures
PK parameter - area under the concentration-time curve from time 0 to infinity (AUCinf)
PK parameter - AUC from time 0 to time of the last measurable concentration (AUClast)
PK parameter - maximum observed concentration (Cmax)
Secondary Outcome Measures
PK parameter - Time to reach maximum observed concentration (Tmax)
PK parameter - half-life (t1/2)
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Assessment of changes from baseline in Clinical laboratory parameters
Assessment of clinically relevant abnormalities in Vital signs
Assessment of physical examinations
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02521545
Brief Title
Single-Dose Study of a New Formulation of BIIB061
Official Title
A Single-Dose Study in Healthy Volunteers to Assess the Pharmacokinetic Profile of a New Formulation of BIIB061
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of the study is to assess the pharmacokinetic (PK) profile of BIIB061 in the new oral formulation in the fasted state in healthy male and female volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BIIB061 in the new formulation in this study population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Oral Remyelination
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIIB061
Arm Type
Experimental
Arm Description
Single oral dose of 30 mg BIIB061 of the new formulation
Intervention Type
Drug
Intervention Name(s)
BIIB061
Intervention Description
Capsule
Primary Outcome Measure Information:
Title
PK parameter - area under the concentration-time curve from time 0 to infinity (AUCinf)
Time Frame
Day 1-4, 6, 10, 14, 21
Title
PK parameter - AUC from time 0 to time of the last measurable concentration (AUClast)
Time Frame
Day 1-4, 6, 10, 14, 21
Title
PK parameter - maximum observed concentration (Cmax)
Time Frame
Day 1-4, 6, 10, 14, 21
Secondary Outcome Measure Information:
Title
PK parameter - Time to reach maximum observed concentration (Tmax)
Time Frame
Day 1-4, 6, 10, 14, 21
Title
PK parameter - half-life (t1/2)
Time Frame
Day 1-4, 6, 10, 14, 21
Title
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time Frame
Up to 21 days
Title
Assessment of changes from baseline in Clinical laboratory parameters
Time Frame
Up to 21 days
Title
Assessment of clinically relevant abnormalities in Vital signs
Time Frame
Up to 21 days
Title
Assessment of physical examinations
Time Frame
Up to 21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
All male subjects must practice effective contraception during the study and be willing and able to continue male contraception for 3 months after the dose of study treatment. All male subjects must also be willing to refrain from sperm donation for at least 3 months after their dose of study treatment.
Must be in good health and have normal vital signs as determined by the Investigator, based on medical history and screening evaluations.
Body mass index of 18.0 to 30.0 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]).
Prior exposure to BIIB061.
History of any clinically significant cardiac, endrocrinologic, hematologic, hepatic, gastric, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, oncologic, or other major disease, as determined by the Investigator.
Treatment with any prescription medication within 28 days prior to and throughout the duration of the study.
Use of any over-the-counter products, including herbal or alternative health preparations within the 14 days prior to the study
Enrollment in any interventional clinical study in which an investigational drug, biologic, device, or approved therapy for investigational use is administered or used within 30 days prior to the study
Any live or attenuated immunization/vaccination given within 30 days prior to the study or planned to be given during the study.
Blood donation within 30 days prior to the study
Surgery within 3 months prior to the study
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Single-Dose Study of a New Formulation of BIIB061
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