Evaluating the Safety, Tolerability, and Pharmacokinetics of BIIB095 in Healthy Participants
NCT ID: NCT03454126
Last Updated: 2019-05-16
Study Results
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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COMPLETED
PHASE1
80 participants
INTERVENTIONAL
2018-03-29
2019-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cohort 1: BIIB095 5 mg
Following an overnight fast from food of at least 8 hours, participants will receive a single dose of either BIIB095 5 mg or placebo orally, followed by a fast of at least 4 hours post dose.
BIIB095
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.
Cohort 2: BIIB095 25 mg
Following an overnight fast from food of at least 8 hours, participants will receive a single dose of either BIIB095 25 mg or placebo orally, followed by a fast of at least 4 hours post dose.
BIIB095
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.
Cohort 3: BIIB095 100 mg
Following an overnight fast from food of at least 8 hours, participants will receive a single dose of either BIIB095 100 mg or placebo orally, followed by a fast of at least 4 hours post dose.
BIIB095
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.
Cohort 4 (Fasted): BIIB095 200 mg
Following an overnight fast from food of at least 8 hours, participants will receive a single dose of either BIIB095 200 mg or placebo orally, followed by a fast of at least 4 hours post dose.
BIIB095
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.
Cohort 4 (Fed): BIIB095 200 mg
After a minimum 2 week washout period, followed by an overnight fast of at least 8 hours, participants will consume a high fat breakfast. Participants will then receive a single dose of either BIIB095 200 mg or placebo orally within 30 minutes after starting the breakfast, followed by a fast from food for at least 4 hours post dose.
BIIB095
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.
Cohort 5: BIIB095 400 mg
Following an overnight fast from food of at least 8 hours, participants will receive a single dose of either BIIB095 400 mg or placebo orally, followed by a fast of at least 4 hours post dose.
BIIB095
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.
Cohort 6: BIIB095 600 mg
Following an overnight fast from food of at least 8 hours, participants will receive a single dose of either BIIB095 600 mg or placebo orally, followed by a fast of at least 4 hours post dose.
BIIB095
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.
Cohort 7: BIIB095 50 mg BID
Participants will receive a single dose of either BIIB095 50 mg or placebo orally BID approximately 12 hours apart from Days 1 to 13, and once in the morning on Day 14. Morning doses will be preceded by an overnight fast from food of at least 8 hours and will be followed by a fast of at least 2 hours post dose. Evening doses will be preceded by a fast from food of at least 2 hours and will be followed by a fast of at least 2 hours post dose.
BIIB095
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.
Cohort 8: BIIB095 100 mg BID
Participants will receive a single dose of either BIIB095 100 mg or placebo orally BID approximately 12 hours apart from Days 1 to 13, and once in the morning on Day 14. Morning doses will be preceded by an overnight fast from food of at least 8 hours and will be followed by a fast of at least 2 hours post dose. Evening doses will be preceded by a fast from food of at least 2 hours and will be followed by a fast of at least 2 hours post dose.
BIIB095
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.
Cohort 9: BIIB095 200 mg BID
Participants will receive a single dose of either BIIB095 200 mg or placebo orally BID approximately 12 hours apart from Days 1 to 13, and once in the morning on Day 14. Morning doses will be preceded by an overnight fast from food of at least 8 hours and will be followed by a fast of at least 2 hours post dose. Evening doses will be preceded by a fast from food of at least 2 hours and will be followed by a fast of at least 2 hours post dose.
BIIB095
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.
Cohort 10: BIIB095 300 mg BID
Participants will receive a single dose of either BIIB095 300 mg or placebo orally BID approximately 12 hours apart from Days 1 to 13, and once in the morning on Day 14. Morning doses will be preceded by an overnight fast from food of at least 8 hours and will be followed by a fast of at least 2 hours post dose. Evening doses will be preceded by a fast from food of at least 2 hours and will be followed by a fast of at least 2 hours post dose.
BIIB095
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.
Interventions
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BIIB095
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.
Eligibility Criteria
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Inclusion Criteria
* Must have a body mass index between 18 and 30 kg/m2, inclusive.
* All women of childbearing potential and all men must practice highly effective contraception during the study and for 5 times the half-life or 3 months, whichever is longer, after their last dose of study treatment. In addition, subjects should not donate sperm or eggs during the study and for at least 3 months after their last dose of study treatment.
* Must be in good health as determined by the Investigator, based on medical history and Screening evaluations.
Exclusion Criteria
* Significant history of fainting or vaso-vagal attacks, as determined by the Investigator.
* Current condition known to affect cardiac conduction, or a personal or familial history of Brugada syndrome.
* Congenital nonhemolytic hyperbilirubinemia (Gilbert's syndrome).
* History or risk of seizures or a history of epilepsy, significant head injury or related neurological disorders (excluding childhood febrile convulsions), as determined by the Investigator.
* Current enrollment in any other drug, biologic, device, or clinical study, or treatment with an investigational drug or approved therapy for investigational use within 30 days (6 months for biologics) prior to Day -1, or 5 half-lives of the agent, whichever is longer.
* Exposure to more than 4 experimental chemical entities within 12 months prior to the first dosing day.
* Breastfeeding, pregnant, or planning to become pregnant during study participation
18 Years
65 Years
ALL
Yes
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Leeds, , United Kingdom
Hammersmith Medicines Research
London, , United Kingdom
Countries
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Other Identifiers
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2017-003982-90
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
255HV101
Identifier Type: -
Identifier Source: org_study_id
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