A Study to Test the Pharmacodynamic, Pharmacokinetic, Safety, and Tolerability of Padsevonil in Healthy Study Participants Receiving Either Ethanol or Cannabidiol
Condition: Healthy Participants
Intervention: Padsevonil; Placebo (PSL)
Intervention description: Padsevonil will be administered in predefined dosages.; Placebo will be provided matching Padsevonil to maintain the blinding.
Intervention MeSH terms: 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: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Ethanol; Cannabidiol; Padsevonil

Summary:

      The purpose of the study is to evaluate the pharmacodynamic (PD) interaction between
      steady-steady treatment with padsevonil (PSL) and Ethanol and the pharmacokinetic (PK)
      interaction between stead-state treatment with PSL and cannabidiol (CBD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must be 18 to 55 years of age inclusive, at the time of signing the
             informed consent

          -  Participants who are overtly healthy as determined by medical evaluation including
             medical history, physical examination, laboratory tests, and cardiac monitoring

          -  Participant must have previous experience with alcohol consumption and, therefore,
             must be familiar with the effects and able to tolerate social amounts of alcohol

          -  Participant has a body weight of at least 50 kg (males) or 45 kg (females) and body
             mass index (BMI) within the range 18 to 30 kg/m2 (inclusive)

          -  Participants are male or female:

          -  A male participant must agree to use contraception as detailed in the protocol during
             the treatment period and for at least 7 days after the last dose of study treatment
             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 1 of the following conditions applies:

          -  Not a woman of childbearing potential (WOCBP) as defined n the protocol OR

          -  A WOCBP who agrees to follow the contraceptive guidance in the protocol during the
             Treatment Period and for at least 90 days after the last dose of study treatment

        Exclusion Criteria:

          -  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

          -  Participant has a history of chronic alcohol or drug abuse within the previous 6
             months or the presence of drug or alcohol dependency at Screening or Day -1 or tests
             positive for alcohol and/or drugs at Screening or Day -1

          -  Participant has a known hypersensitivity to any components of the study medication or
             comparative drugs (and/or an investigational device) as stated in this protocol

          -  Participant has a history of unexplained syncope or a family history of sudden death
             due to long QT syndrome

          -  Participant has 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

          -  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

          -  Participant has used hepatic enzyme-inducing drugs within 2 months prior to dosing

          -  Participant has alanine transaminase (ALT), aspartate aminotransferase (AST), or
             alkaline phosphatase (ALP) >1.0x upper limit of normal (ULN)

          -  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)

          -  Participant has any clinically relevant electrocardiogram (ECG) finding at the
             Screening Visit or at Baseline

          -  Participant has the presence of hepatitis B surface antigen (HBsAg) at Screening or
             within 3 months prior to dosing

          -  Participant has a positive hepatitis C antibody test result at Screening or within 3
             months prior to starting study intervention

          -  Participant has a positive human immunodeficiency virus (HIV) antibody test