Evaluating the Safety, Tolerability, and Pharmacokinetics of BIIB095 in Healthy Participants

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: BIIB095; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03454126

255HV101

2017-003982-90 (EudraCT Number)

Details and patient eligibility

About

The primary objective of the study is to evaluate the safety and tolerability of single- and multiple-ascending oral doses of BIIB095 in healthy participants. The secondary objectives are to characterize the single- and multiple-oral-dose PK of BIIB095 in healthy participants and to investigate the effect of food on the single-oral-dose PK of BIIB095 in healthy participants.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Ability of the subject to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
• 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.

Key Exclusion Criteria:

• History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
• 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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 11 patient groups

Cohort 1: BIIB095 5 mg

Experimental group

Description:

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.

Treatment:

Drug: BIIB095

Drug: Placebo

Cohort 2: BIIB095 25 mg

Experimental group

Description:

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.

Treatment:

Drug: BIIB095

Drug: Placebo

Cohort 3: BIIB095 100 mg

Experimental group

Description:

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.

Treatment:

Drug: BIIB095

Drug: Placebo

Cohort 4 (Fasted): BIIB095 200 mg

Experimental group

Description:

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.

Treatment:

Drug: BIIB095

Drug: Placebo

Cohort 4 (Fed): BIIB095 200 mg

Experimental group

Description:

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.

Treatment:

Drug: BIIB095

Drug: Placebo

Cohort 5: BIIB095 400 mg

Experimental group

Description:

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.

Treatment:

Drug: BIIB095

Drug: Placebo

Cohort 6: BIIB095 600 mg

Experimental group

Description:

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.

Treatment:

Drug: BIIB095

Drug: Placebo

Cohort 7: BIIB095 50 mg BID

Experimental group

Description:

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.

Treatment:

Drug: BIIB095

Drug: Placebo

Cohort 8: BIIB095 100 mg BID

Experimental group

Description:

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.

Treatment:

Drug: BIIB095

Drug: Placebo

Cohort 9: BIIB095 200 mg BID

Experimental group

Description:

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.

Treatment:

Drug: BIIB095

Drug: Placebo

Cohort 10: BIIB095 300 mg BID

Experimental group

Description:

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.

Treatment:

Drug: BIIB095

Drug: Placebo