An Open-Label, Randomized, Two-Way Crossover Study to Investigate the Potential Pharmacokinetic Interaction of Padsevonil With Oral Contraceptives in Healthy Female Participants
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Ethinylestradiol in Part 2
研究概览
简要总结
The purpose of the study is to investigate the effect of steady-state padsevonil on the pharmacokinetic of a single dose oral contraceptive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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:
- •Oral contraceptive or oral hormone replacement therapy within prior 30 days
- •Implanted hormonal contraceptives within prior 6 months
- •Injectable contraceptives within prior 12 months
- •Topical controlled-delivery contraceptives within prior 3 months
- •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:
- •QT interval corrected for heart rate using Bazett's formula (QTcB) or Fridericia's formula (QTcF) >450 ms in 2 of 3 ECG recordings;
- •other conduction abnormalities (defined as PR interval ≥220 ms);
- •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
研究组 & 干预措施
Oral contraceptive
Participants will receive oral contraceptive in Period 2 of Sequence A and Period 1 of Sequence B of Part 1 and Part 2.
干预措施: Microgynon 30® (Drug)
Oral contraceptive + padsevonil
Participants will receive padsevonil + oral contraceptive in Period 1 of Sequence A and Period 2 of Sequence B of Part 1 and Part 2.
干预措施: Padsevonil (Drug)
Oral contraceptive + padsevonil
Participants will receive padsevonil + oral contraceptive in Period 1 of Sequence A and Period 2 of Sequence B of Part 1 and Part 2.
干预措施: Microgynon 30® (Drug)
结局指标
主要结局
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Ethinylestradiol in Part 2
时间窗: 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
AUC0-inf is the area under the concentration time curve from time 0 extrapolated to infinity of ethinylestradiol.
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Ethinylestradiol in Part 1
时间窗: 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
Area under the concentration time curve from time 0 extrapolated to infinity for ethinylestradiol was reported. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms.
Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol in Part 1
时间窗: 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
Cmax is maximum observed plasma concentration of ethinylestradiol (EE). Values were determined from the observed concentration and time data. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms.
Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol in Part 2
时间窗: 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
Cmax is maximum observed plasma concentration of ethinylestradiol.
Maximum Observed Plasma Concentration (Cmax) of Levonorgestrel in Part 2
时间窗: 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
Cmax is maximum observed plasma concentration of levonorgestrel.
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Levonorgestrel in Part 1
时间窗: 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
AUC0-inf is the area under the concentration time curve from time 0 extrapolated to infinity for levonorgestrel was reported. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms.
Maximum Observed Plasma Concentration (Cmax) of Levonorgestrel in Part 1
时间窗: 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
Cmax is maximum observed plasma concentration of levonorgestrel. Values were determined from the observed concentration and time data. This outcome measure was planned to be analyzed for 'Oral Contraceptive Alone' and 'PSL + Oral Contraceptive' arms.
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Levonorgestrel in Part 2
时间窗: 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
AUC0-inf is the area under the concentration time curve from time 0 extrapolated to infinity of levonorgestrel.
次要结局
- Steady State Plasma Concentration (Cmax,ss) of Padsevonil in Part 1(Day 12 and 13 (Sequence A) and Day 29 and 30 (Sequence B))
- Area Under the Concentration-time Curve From Time 0 to Time Tau (AUC[0-tau]) of Padsevonil in Part 1(Day 12 and 13 (Sequence A) and Day 29 and 30 (Sequence B))
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) in Part 1(From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 46))
- Percentage of Participants With Serious TEAEs in Part 1(From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 46))
- Percentage of Participants With Serious TEAEs in Part 2(From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 42))
- Area Under the Concentration-time Curve From Time 0 to Time Tau (AUC[0-tau]) of Padsevonil in Part 2(Day 8 and 9 (Sequence A) and Day 25 and 26 (Sequence B))
- Percentage of Participants With TEAEs in Part 2(From Baseline up to Safety Follow-Up during Treatment Sequences A and B (up to Day 42))
- Steady State Plasma Concentration (Cmax,ss) of Padsevonil in Part 2(Day 8 and 9 (Sequence A) and Day 25 and 26 (Sequence B))