A Study to Test the Interaction of Padsevonil With Oral Contraceptives in Healthy Female Participants

UCB

Status and phase: Terminated; Phase 1

Conditions: Healthy Female Participants

Treatments: Drug: Microgynon 30®; Drug: Padsevonil

Study type: Interventional

Funder types: Industry

Identifiers

NCT04131517

2019-002194-54 (EudraCT Number)

UP0035

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

14 participants in 2 patient groups

Oral contraceptive

Experimental group

Description:

Participants will receive oral contraceptive in Period 2 of Sequence A and Period 1 of Sequence B of Part 1 and Part 2.

Treatment:

Drug: Microgynon 30®

Oral contraceptive + padsevonil

Experimental group

Description:

Participants will receive padsevonil + oral contraceptive in Period 1 of Sequence A and Period 2 of Sequence B of Part 1 and Part 2.

Treatment:

Drug: Microgynon 30®

Drug: Padsevonil