A Study to Test the Cardiac Effects of Padsevonil in Healthy Study Participants
Condition: Healthy Study Participants
Intervention: Padsevonil; Moxifloxacin; Placebo
Intervention description: Pharmaceutical form: Film-coated tablet
Route of administration: Oral use
Study participants will receive padsevonil in a pre-specified dosing sequence during the Treatment Period; Pharmaceutical form: Film-coated tablet
Route of administration: Oral use
Study participants will receive moxifloxacin once during the Treatment Period; Pharmaceutical form: Film-coated tablet
Route of administration: Oral use
Study participants will receive placebo in a pre-specified sequence during the Treatment Period to match padsevonil and maintain the blinding
Intervention MeSH terms: Moxifloxacin; Padsevonil
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy study participants; Padsevonil; Moxifloxacin; Cardiac repolarization

Summary:

      The purpose of the study is to evaluate the effects on cardiac repolarization of high-dose
      padsevonil (PSL) in comparison to placebo in healthy study participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must be 18 to 55 years of age inclusive, at the time of signing the
             informed consent form (ICF)

          -  Participant who is overtly healthy as determined by medical evaluation including
             medical history, physical examination, laboratory tests, and cardiac monitoring

          -  Body weight of at least 50 kilogram (kg) (males) or 45 kg (females) and body mass
             index (BMI) within the range 18 to 30 kg/m2 (inclusive)

          -  Male and/or female:

        A male study participant must agree to use contraception during the Treatment Period and
        for at least 90 days after the last dose of study medication and refrain from donating
        sperm during this period

        A female participant is eligible to participate if she is not pregnant, not breastfeeding,
        and at least one of the following conditions applies:

        Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the
        contraceptive guidance during the Treatment Period and for at least 90 days after the last
        dose of study medication

        Exclusion Criteria:

          -  Participant has a known hypersensitivity to any components of the study medication or
             comparative drugs as stated in this protocol or history of tendon pathology secondary
             to use of quinolone antibiotics

          -  Participant has a history of unexplained syncope or a family history of sudden death
             due to long QT syndrome

          -  Participant has a present condition of respiratory or cardiovascular disorders, eg,
             cardiac insufficiency, coronary heart disease, hypertension, arrhythmia,
             tachyarrhythmia, or myocardial infarction

          -  Past or intended use of over-the-counter (OTC) or prescription medication including
             herbal medications within 2 weeks or 5 half-lives prior to dosing.

          -  Participant has used hepatic enzyme-inducing drugs (eg, glucocorticoids,
             phenobarbital, isoniazid, phenytoin, rifampicin, etc) within 2 months prior to the
             first dose of study medication

          -  Participant has previously received padsevonil (PSL) in this or any other study

          -  Participant has any clinically relevant electrocardiogram (ECG) finding at the
             Screening Visit or at Baseline. 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 participant with any of the following
             findings will be excluded:

               1. QT interval corrected for heart rate using the Fridericia method (QTcF) ≥450 ms
                  (on mean of triplicate ECG recordings);

               2. Other conduction abnormalities (defined as PR interval >220 ms);

               3. QRS interval >109 ms;

               4. Any rhythm other than sinus rhythm;

               5. Any history of Wolff-Parkinson-White Syndrome, Brugada Syndrome, unexplained
                  syncope, or ventricular tachycardia;

               6. Family history of QTc prolongation or of unexplainable sudden death at <50 years
                  of age

          -  Participant has made a blood or plasma donation or has had a comparable blood loss
             (>450 mL) within 30 days prior to the Screening Visit. Blood donation during the study
             is not permitted