The Effect of Multiple Doses of BI 425809 on the Pharmacokinetics of Multiple Doses of a Combination of Ethinylestradiol and Levonorgestrel Following Oral Administration in Healthy Premenopausal Female Subjects (an Open-label, Two-period, Fixed Sequence Design Trial With run-in Period)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss )
研究概览
简要总结
The main objective of this trial is to investigate the possible effect of multiple oral doses of BI 425809 on the steady state pharmacokinetics of ethinylestradiol (EE) and levonogestrel (LNG) (administered as the combined oral contraceptive Microgynon®).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy premenopausal female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure(BP), Pulse rate (PR)), 12-lead Electrocardiogram (12-lead ECG), and clinical laboratory tests without any clinically significant abnormalities.
- •Age of 18 to 35 years (inclusive).
- •Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive).
- •Signed and dated written informed consent in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- •Female subjects who meet any of the following criteria starting from at least 30 days before the first administration of BI 425809 and until 30 days after trial completion:
- •Use of adequate contraception, e.g. non-hormonal intrauterine device plus condom.
- •Sexually abstinent.
- •A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment).
- •Surgically sterilised (including hysterectomy).
排除标准
- •Subjects will not be allowed to participate, if any of the following general criteria apply:
- •Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
- •Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm).
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
- •Any evidence of a concomitant disease assessed as clinically relevant by the investigator.
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
- •Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair).
- •Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders.
- •History of relevant orthostatic hypotension, fainting spells, or blackouts. Further exclusion criteria apply.
研究组 & 干预措施
Microgynon® (R), then Microgynon® + Iclepertin (T)
干预措施: Microgynon® (Drug)
Microgynon® (R), then Microgynon® + Iclepertin (T)
干预措施: Iclepertin (Drug)
结局指标
主要结局
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss )
时间窗: Up to 22 days
Maximum measured concentration of the analyte in plasma at steady state over (Cmax,ss)
时间窗: Up to 22 days
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ(Cmin,ss)
时间窗: Up to 22 days
Area Under the Concentration-time Curve of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)
时间窗: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.
This outcome measured the area under the concentration-time curve of ethinylestradiol (EE), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Area Under the Concentration-time Curve of Levonogestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)
时间窗: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.
This outcome measured the area under the concentration-time curve of levonogestrel (LNG), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Maximum Measured Concentration of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)
时间窗: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.
This outcome measured the maximum measured concentration of ethinylestradiol (EE), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Maximum Measured Concentration of Levonorgestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)
时间窗: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.
This outcome measured the maximum measured concentration of levonorgestrel (LNG), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Minimum Measured Concentration of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss )
时间窗: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.
This outcome measured the minimum measured concentration of ethinylestradiol (EE), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Minimum Measured Concentration of Levonorgestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss )
时间窗: From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.
This outcome measured the minimum measured concentration of Levonorgestrel (LNG), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
次要结局
未报告次要终点