A Study in Healthy Men to Test How Bosentan Influences the Amount of Zongertinib in the Blood
The Effect of Multiple Oral Doses of Bosentan on the Single Oral Dose Pharmacokinetics of Zongertinib in Healthy Male Subjects (an Open-label, Two-treatment, Two-period Fixed Sequence Trial)
研究概览
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
-
Biberach、德国、88397
- Humanpharmakologisches Zentrum Biberach
-
-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion criteria :
- Healthy male trial participant 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 (ECG), and clinical laboratory tests
- Age of 25 to 55 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 Council for Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Exclusion criteria :
- Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate (PR) outside the range of 45 to 90 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
- Further exclusion criteria apply.
学习计划
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：Fixed sequence arm
First reference treatment: Zongertinib Then test treatment: Bosentan and Zongertinib
|
宗格替尼
波森坦
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
血浆中分析物的最大测量浓度 (Cmax)
大体时间：最多 8 天
|
最多 8 天
|
|
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
大体时间：up to 8 days
|
up to 8 days
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
从 0 到最后一个可量化数据点的时间间隔内血浆中分析物的浓度-时间曲线下面积 (AUC0-tz)
大体时间：最多 8 天
|
最多 8 天
|
合作者和调查者
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 1479-0047
- 2025 (美国 NIH 拨款/合同：Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- U1111-1325-4206 (注册表标识符：WHO International Clinical Trials Registry Platform (ICTRP))
- 2025-523193-16 (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)？
IPD 计划说明
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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.