Study to Evaluate the Effect of Coadministered Erythromycin on the Pharmacokinetics and Safety of Padsevonil
Condition: Pharmacokinetics
Intervention: Padsevonil (UCB0942); Erythromycin
Intervention description: Pharmaceutical Form: film-coated tablet
Route of Administration: Oral use; Pharmaceutical Form: film-coated tablet
Route of Administration: Oral use
Intervention MeSH terms: Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Padsevonil
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Padsevonil

Summary:

      The purpose of this study is to evaluate and compare the Pharmacokinetics (PK) of concomitant
      administration of Padsevonil (PSL) in the presence and absence of erythromycin in healthy
      study participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Study participant is male or female and between 18 and 55 years of age (inclusive)

          -  Study participant is of a body weight of at least 50 kg for males and 45 kg for
             females, as determined by a body mass index (BMI) between 18 and 30 kg/m^2

          -  Female study participants use an efficient form of contraception for the duration of
             the study (unless menopausal). Hormonal contraception may be susceptible to an
             interaction with the Investigational Medicinal Product (IMP), which may reduce the
             efficacy of the contraception method. The potential for reduced efficacy of any
             hormonal contraception methods requires that a barrier method (preferably male condom)
             also be used

          -  Study participant has clinical laboratory test results within the local reference
             ranges or values are considered as not clinically relevant by the investigator and
             approved by the UCB Study Physician

          -  Study participant has Blood Pressure (BP) and pulse rate within normal range in supine
             position after 10 minutes of rest

          -  Male study participant agrees that, during the study period, when having sexual
             intercourse with a woman of childbearing potential, he will use an efficient barrier
             contraceptive (condom plus spermicide) AND that the respective partner will use an
             additional efficient contraceptive method

        Exclusion Criteria:

          -  Study participant has previously received Investigational Medicinal Product (IMP) in
             this study

          -  Study participant has participated in another study of an IMP (or a medical device)
             within the previous 3 months before Screening (or within 5 half-lives for the IMP,
             whichever is longer) or is currently participating in another study of an IMP (or a
             medical device)

          -  Study participant has a history of drug or alcohol dependency within the previous 6
             months or tests positive for alcohol (breath test) and/or drugs of abuse (urine test)
             at the Screening Visit or at any time during confinement

          -  Study participant has made a blood or plasma donation or has had a comparable blood
             loss (>400 mL) within the last 3 months prior to the Screening Visit

          -  Study participant smokes more than 5 cigarettes per day (or equivalent) or has done so
             within 6 months prior to the Screening Visit

          -  Study participant is taking any concomitant medication currently or within 2 weeks
             prior to the first day of dosing with the exception of paracetamol (acetaminophen)

          -  Study participant has any clinically relevant Electrocardiogram (ECG) finding at the
             Screening Visit or confinement

          -  Study participant has a history within the last 5 years or present condition of
             malignancy, with the exception of basal cell carcinoma

          -  Female study participant tests positive for pregnancy, plans to get pregnant during
             the participation in the study, or who is breastfeeding