A Study to Test the Safety, and Tolerability of Padsevonil in Healthy Male Japanese Study Participants
Condition: Healthy Japanese Participants
Intervention: Padsevonil
Intervention description: Padsevonil will be administered in predefined dosages.
Intervention MeSH terms: Padsevonil
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: Male
Minimum age: 20 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Padsevonil; CYP2C19; Healthy Japanese Participants; Pharmacokinetics

Summary:

      The purpose of the study is to investigate the pharmacokinetics (PK) of padesevonil in
      CYP2C19 genotyped healthy male Japanese study participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The study participant must be 20 to 55 years of age inclusive, at the time of signing
             the informed consent

          -  The study participant is overtly healthy as determined by medical evaluation including
             medical history, physical examination, laboratory tests, and cardiac monitoring

          -  The study participant is of Japanese descent as evidenced by appearance and verbal
             confirmation of familial heritage

          -  The study participant has a body weight ≥50 kg and body mass index within the range
             [18 to 30] kg/m^2 (inclusive)

          -  The study participant is male

        Exclusion Criteria:

          -  The study participant has any medical or psychiatric condition that, in the opinion of
             the Investigator, could jeopardize or would compromise the study participant's ability
             to participate in this study, such as a history of schizophrenia, or other psychotic
             disorder, bipolar disorder, or severe unipolar depression. The presence of potential
             psychiatric exclusion criteria will be determined based on the psychiatric history
             collected at the Screening Visit

          -  The study participant has a history or presence of cardiovascular, respiratory,
             hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological
             disorders, capable of significantly altering the absorption, metabolism, or
             elimination of drugs; constituting a risk when taking the study intervention; or
             interfering with the interpretation of data

          -  The study participant has a history of unexplained syncope or a family history of
             sudden death due to long QT syndrome

          -  The study participant has a lifetime history of suicide attempt (including an actual
             attempt, interrupted attempt, or aborted attempt), or has had suicidal ideation in the
             past 6 months as indicated by a positive response ("Yes") to either Question 4 or
             Question 5 of the "Screening/Baseline" version of the Columbia-Suicide Severity Rating
             Scale (C-SSRS) at Screening

          -  The study participant has alanine aminotransferase (ALT), aspartate aminotransferase
             (AST), or alkaline phosphatase (ALP) >1.0 x upper limit of normal (ULN)

          -  The study participant has bilirubin >1.0 x ULN (isolated bilirubin >1.0 x ULN is
             acceptable if bilirubin is fractionated and direct bilirubin <35 %)

          -  The study participant has current or chronic history of liver disease or known hepatic
             or biliary abnormalities

          -  The study participant has any clinically relevant electrocardiogram (ECG) finding at
             the Screening Visit or at Baseline.

          -  The study participant has made a blood or plasma donation or has had a comparable
             blood loss (>450 mL) within the last 30 days prior to Screening. Blood donation during
             the study is not permitted