Status:
COMPLETED
Evaluating the Safety, Tolerability, and Pharmacokinetics of BIIB095 in Healthy Participants
Lead Sponsor:
Biogen
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 character...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
March 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03454126
Start Date
March 29 2018
End Date
April 30 2019
Last Update
May 16 2019
Active Locations (2)
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1
Research Site
Leeds, United Kingdom, LS2 9LH
2
Hammersmith Medicines Research
London, United Kingdom, NW10 7EW