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

• Status: Completed
• Trial end date: 2019-04-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Biogen

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.