A Study to Evaluate the Pharmacokinetics and Safety of Brivaracetam in Healthy Chinese Subjects
Condition: Healthy Participants
Intervention: brivaracetam
Intervention description: Pharmaceutical form: Film-coated tablets
Concentration: 100 mg tablets
Route of administration: Oral use
Intervention MeSH terms: Brivaracetam
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Epilepsy; Healthy participants; Phase 1; Brivaracetam

Summary:

      The purpose of the study is to assess the pharmacokinetics, safety, and tolerability of
      brivaracetam after a single dose and multiple doses in healthy adult Chinese Study
      Participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved
             written Informed Consent form is signed and dated by the subject

          -  Subject is considered reliable and capable of adhering to the protocol (eg, able to
             understand and complete diaries), visit schedule, or medication intake according to
             the judgment of the Investigator

          -  Subjects are Chinese males and females born in China between 18 and 45 years of age
             (both inclusive) whose parents are of Chinese origin

          -  Subjects with body mass index (BMI) from 19 to 24 kg/m^2 (both inclusive). Minimum
             body weight is equal to or more than 50 kg

          -  Subjects with supine blood pressure levels of between 90 to 150 and 60 to 90 mmHg
             (inclusive) for systolic and diastolic, respectively, with pulse rate of 50 to 100
             beats per minute (bpm) (supine position, inclusive) at Screening Visit

          -  Subjects without clinically relevant abnormalities in a standard 12-lead
             Electrocardiogram (ECG) at Screening Visit judged by the Investigators

          -  Subjects with laboratory values within the reference range at Screening Visit, or
             those with values exceeding the reference range but judged by the Investigators to be
             not clinically significant to their participation in the study

        Exclusion Criteria:

          -  Subject has participated in another study of an investigational medicinal product
             (IMP) (or a medical device) within the previous 30 days or is currently participating
             in another study of an IMP (or a medical device)

          -  Subject has any medical or psychiatric condition that, in the opinion of the
             Investigator, could jeopardize or would compromise the subject's ability to
             participate in this study

          -  Pregnant, lactating, or sexually active women with childbearing potential who are not
             using a medically accepted birth control method

          -  Subject has a known hypersensitivity to any components of the IMP or any of its
             excipients

          -  Subjects with any previous or current cardiovascular, respiratory, hepatic, renal,
             digestive, endocrine, or nervous system disorder that may affect absorption,
             secretion, metabolism, or excretion of the investigational product per Investigator
             judgement

          -  Subjects showing a positive result for hepatitis B surface antigen, hepatitis C virus
             antibody, human immunodeficiency virus antibody, or syphilis test at Screening Visit