Clinical trial NCT04131517: A Study to Test the Interaction of Padsevonil With Oral Contraceptives in Healthy Female Participants
Official title: An Open-Label, Randomized, Two-Way Crossover Study to Investigate the Potential Pharmacokinetic Interaction of Padsevonil With Oral Contraceptives in Healthy Female Participants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Female Participants
Keywords: Padsevonil
Contraceptives
Healthy female participants
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2019-10-18
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol in Part 1
timeFrame: Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B
measure: Maximum Observed Plasma Concentration (Cmax) of Levonorgestrel in Part 1
timeFrame: Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B
measure: Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol in Part 2
timeFrame: Day 9, 10, 11, 26, 27 and 28 during Treatment Sequence A and on Day 1, 2, 3, 26, 27 and 28 during Treatment Sequence B
measure: Maximum Observed Plasma Concentration (Cmax) of Levonorgestrel in Part 2
timeFrame: Day 9, 10, 11, 26, 27 and 28 during Treatment Sequence A and on Day 1, 2, 3, 26, 27 and 28 during Treatment Sequence B
measure: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Ethinylestradiol in Part 1
timeFrame: Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B
measure: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Levonorgestrel in Part 1
timeFrame: Day 13, 14, 15, 34, 35, 36 during Treatment Sequence A and on Day 1, 2, 3, 30, 31 and 32 during Treatment Sequence B
measure: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Ethinylestradiol in Part 2
timeFrame: Day 9, 10, 11, 26, 27 and 28 during Treatment Sequence A and on Day 1, 2, 3, 26, 27 and 28 during Treatment Sequence B
measure: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Levonorgestrel in Part 2
timeFrame: Day 9, 10, 11, 26, 27 and 28 during Treatment Sequence A and on Day 1, 2, 3, 26, 27 and 28 during Treatment Sequence B
Secondary outcomes:
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) in Part 1
timeFrame: From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 46)
measure: Percentage of Participants With Serious TEAEs in Part 1
timeFrame: From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 46)
measure: Percentage of Participants With TEAEs in Part 2
timeFrame: From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 42)
measure: Percentage of Participants With Serious TEAEs in Part 2
timeFrame: From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 42)
measure: Steady State Plasma Concentration (Cmax,ss) of Padsevonil in Part 1
timeFrame: Day 12 and 13 (Sequence A) and Day 29 and 30 (Sequence B)
measure: Steady State Plasma Concentration (Cmax,ss) of Padsevonil in Part 2
timeFrame: Day 8 and 9 (Sequence A) and Day 25 and 26 (Sequence B)
measure: Area Under the Concentration-time Curve From Time 0 to Time Tau (AUC[0-tau]) of Padsevonil in Part 1
timeFrame: Day 12 and 13 (Sequence A) and Day 29 and 30 (Sequence B)
measure: Area Under the Concentration-time Curve From Time 0 to Time Tau (AUC[0-tau]) of Padsevonil in Part 2
timeFrame: Day 8 and 9 (Sequence A) and Day 25 and 26 (Sequence B)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Up0035 001
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: