A Study to Test the Safety and Tolerability of Single and Multiple Doses of Padsevonil in Adult and Elderly Study Participants
Condition: Elderly Study Participants; Adult Study 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: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Padsevonil; Phase 1; Pharmacokinetic

Summary:

      The purpose of the study is to evaluate the plasma pharmacokinetic of padsevonil in adult and
      elderly study participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Study participants in the adult cohort must be ≥18 to 64 years of age at the time of
             signing the informed consent form (ICF)

          -  Study participants in the elderly cohort must be ≥65 years of age at the time of
             signing the ICF

          -  Study participants who are overtly healthy as determined by medical evaluation,
             including medical history, physical examination, laboratory tests, and cardiac
             monitoring. In addition, elderly study participants must be considered to be in
             general good physical and mental health

          -  Study participants must have a body weight of at least 50 kg for males and 45 kg for
             females, and a body mass index within the range of 18 to 32 kg/m2 (inclusive)

        Exclusion Criteria:

          -  Study participant has a current or past psychiatric condition that, in the opinion of
             the Investigator, could compromise the study participant's safety or ability to
             participate in this study, or 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
             Screening

          -  Study participant has 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

          -  Study participant has a known hypersensitivity to any components of the study
             medication as stated in this protocol

          -  Subject has a history of unexplained syncope or a family history of sudden death due
             to long QT syndrome

          -  Study participant has abnormal blood pressure

          -  Study participant has had lymphoma, leukemia, or any malignancy within the past 5
             years, except for basal cell or squamous epithelial carcinomas of the skin that have
             been resected with no evidence of metastatic disease for 3 years

          -  Study participant has a lifetime history of suicide 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

          -  Study participant has past or intended use of over-the-counter or prescription
             medication, including herbal medications within 2 weeks or 5 half-lives prior to
             dosing

          -  The study participant has used hepatic enzyme-inducing drugs within 2 months prior to
             dosing

          -  Study participant has previously received padsevonil (PSL) in this or another study

          -  Study participant has alanine aminotransferase (ALT), aspartate aminotransferase
             (AST), or alkaline phosphatase (ALP) >1.0x upper limit of normal (ULN)

          -  Study participant has bilirubin >1.0xULN (isolated bilirubin >1.0xULN is acceptable if
             bilirubin is fractionated and direct bilirubin <35%)

          -  Study participant has current or chronic history of liver disease or known hepatic or
             biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic
             gallstones)

          -  Study participant has any clinically relevant electrocardiogram (ECG) finding at
             Screening or at Baseline. Study participant has an abnormality in the 12-lead ECG
             that, in the opinion of the Investigator, increases the risks associated with
             participating in the study. In addition, any study participant with any of the
             following findings will be excluded: (a) QT interval corrected for heart rate using
             Bazett's formula (QTcB) or Fridericia's formula (QTcF) >450 ms in study participants
             in 2 of 3 ECG recordings; (b) other conduction abnormalities (defined as PR interval
             ≥220 ms); (c) irregular rhythms other than sinus arrhythmia or occasional, rare
             supraventricular or rare ventricular ectopic beats. In case of an out of range result,
             1 repeat will be allowed. If out of range again, the study participant cannot be
             included