A Study to Test the Interaction of Padsevonil With Oral Contraceptives in Healthy Female Participants
Condition: Healthy Female Participants
Intervention: Padsevonil; Microgynon 30®
Intervention description: Study Medication: Padsevonil Dosage formulation: Oral tablets; 400 mg BID (Part 1) and 200 mg BID (Part 2); Study Medication: Microgynon 30® Dosage formulation: Oral tablets Dose: Ethinyl estradiol 30 µg + levonorgestrel 150 µg
Intervention MeSH terms: Padsevonil; Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Padsevonil; Contraceptives; Healthy female participants

Summary:

      The purpose of the study is to investigate the effect of steady-state padsevonil on the
      pharmacokinetic of a single dose oral contraceptive.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must be aged 18 years of age or greater, at the time of signing the
             informed consent

          -  Participant must be a premenopausal female with no indication of abnormal or
             gestational/lactational hypothalamic-pituitary-ovarian function. Menopause will be
             defined for the purpose of this study as amenorrhea of ≥12 months for which no other
             reason has been identified

          -  Participant must not be pregnant or breastfeeding. Participant must agree to use an
             effective form of contraception (other than hormonal methods) for the duration of the
             Treatment Period and for at least 90 days (or 5 terminal half-lives) after the last
             dose of study medication

          -  Participant must be in good physical and mental health as determined by medical
             evaluation including medical history, physical examination, laboratory tests, and
             cardiac monitoring

          -  Participant must have body weight of at least 45 kg and body mass index within the
             range 18 to 30 kg/m^2 (inclusive)

        Exclusion Criteria:

          -  Participant has a history of discontinued use of oral contraceptives (OC) for medical
             reasons

          -  Participant has any medical reason that would contraindicate the administration of OC
             (per label)

          -  Participant has used any of the following within the specified time period prior to
             first dose of study medication:

               1. Oral contraceptive or oral hormone replacement therapy within prior 30 days

               2. Implanted hormonal contraceptives within prior 6 months

               3. Injectable contraceptives within prior 12 months

               4. Topical controlled-delivery contraceptives within prior 3 months

               5. Hormone-releasing intrauterine devices ('coils') within prior 3 months

          -  Participant has other relevant gynecological disorders (such as premature ovarian
             failure or endometriosis)

          -  Participant has any clinically relevant electrocardiogram (ECG) finding at the
             Screening Visit or at Baseline (Day -1) 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:

               1. QT interval corrected for heart rate using Bazett's formula (QTcB) or
                  Fridericia's formula (QTcF) >450 ms in 2 of 3 ECG recordings;

               2. other conduction abnormalities (defined as PR interval ≥220 ms);

               3. 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 the result is out-of-range again, the study
                  participant cannot be included