一项针对健康女性的研究，以测试 BI 425809 是否会影响血液中避孕药的含量
2026年4月16日 更新者：Boehringer Ingelheim
多剂量 BI 425809 对健康绝经前女性受试者口服多剂量炔雌醇和左炔诺孕酮组合的药代动力学的影响（开放标签、两期、固定序列设计试验，带磨合期）
该试验的主要目的是研究多次口服 BI 425809 对炔雌醇 (EE) 和左炔诺孕酮 (LNG)（作为复方口服避孕药 Microgynon® 给药）的稳态药代动力学的可能影响。
研究概览
研究类型
介入性
注册 (实际的)
19
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Mannheim、德国、68167
- CRS Clinical Research Services Mannheim GmbH
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 35年 (成人)
接受健康志愿者
是的
描述
纳入标准：
- 根据研究者的评估，健康的绝经前女性受试者，基于完整的病史，包括体格检查、生命体征（血压（BP）、脉率（PR））、12 导联心电图（12 导联心电图）和临床实验室测试没有任何临床显着异常。
- 年龄18至35岁（含）。
- 体重指数 (BMI) 为 18.5 至 29.9 公斤/平方米（含）。
- 在进入试验之前，根据国际协调良好临床实践会议 (ICH-GCP) 和当地立法签署并注明日期的书面知情同意书。
从首次施用 BI 425809 前至少 30 天开始至试验完成后 30 天满足以下任何标准的女性受试者：
- 使用适当的避孕措施，例如 非激素宫内节育器加避孕套。
- 性禁欲。
- 输精管结扎术的性伴侣（入学前至少 1 年进行过输精管结扎术）。
- 手术绝育（包括子宫切除术）。
排除标准：
如果以下任何一般标准适用，则不允许受试者参加：
- 任何体检结果（包括 BP、PR 或 ECG）偏离正常并由研究者评估为临床相关。
- 重复测量收缩压超出 90 至 140 毫米汞柱 (mmHg) 范围，舒张压超出 50 至 90 毫米汞柱范围，或脉率超出每分钟 45 至 90 次心跳 (bpm) ).
- 研究者认为具有临床相关性的超出参考范围的任何实验室值。
- 研究者评估为具有临床相关性的伴随疾病的任何证据。
- 胃肠道、肝脏、肾脏、呼吸系统、心血管、代谢、免疫或荷尔蒙失调。
- 可能干扰试验药物药代动力学的胆囊切除术或其他胃肠道手术（阑尾切除术或单纯疝修补术除外）。
- 中枢神经系统疾病（包括但不限于任何类型的癫痫发作或中风），以及其他相关的神经或精神疾病。
- 相关的体位性低血压、昏厥发作或停电的病史。 进一步的排除标准适用。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Microgynon® (R), then Microgynon® + Iclepertin (T)
|
伊可培汀
其他名称：
炔雌醇 (EE) 和左炔诺孕酮 (LNG)
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Area Under the Concentration-time Curve of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)
大体时间：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.
|
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.
|
|
Area Under the Concentration-time Curve of Levonogestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)
大体时间：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.
|
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.
|
|
Maximum Measured Concentration of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)
大体时间：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.
|
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.
|
|
Maximum Measured Concentration of Levonorgestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)
大体时间：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.
|
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.
|
|
Minimum Measured Concentration of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss )
大体时间：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.
|
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.
|
|
Minimum Measured Concentration of Levonorgestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss )
大体时间：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.
|
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.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年11月24日
初级完成 (实际的)
2023年10月4日
研究完成 (实际的)
2023年10月4日
研究注册日期
首次提交
2022年11月7日
首先提交符合 QC 标准的
2022年11月7日
首次发布 (实际的)
2022年11月14日
研究记录更新
最后更新发布 (实际的)
2026年5月6日
上次提交的符合 QC 标准的更新
2026年4月16日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 1346-0036
- 2022-500050-42-00 (注册表标识符：CTIS)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
由勃林格殷格翰赞助的 I 至 IV 期介入性和非介入性临床研究均在共享原始临床研究数据和临床研究文件的范围内。 例外情况可能适用，例如 研究勃林格殷格翰不是许可持有人的产品；关于药物制剂和相关分析方法的研究，以及与使用人体生物材料的药代动力学相关的研究；在单个中心进行或针对罕见疾病的研究（如果患者数量较少，因此匿名限制）。
有关更多详细信息，请参阅：
https://www.mystudywindow.com/msw/datatransparency
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.