A Study to Test How Well Different Doses of BI 3821001 Are Tolerated by Healthy People
A Phase I Single-blind, Randomised, Placebo-controlled, Parallel Group Design Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 3821001 Administered to Healthy Trial Participants
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3821001 administrations of multiple rising doses.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名：Boehringer Ingelheim
- 电话号码：018002430127
- 邮箱：clintriage.rdg@boehringer-ingelheim.com
学习地点
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Berlin、德国、13627
- 招聘中
- CRS Clinical Research Services Berlin GmbH
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接触：
- Boehringer Ingelheim
- 电话号码：08007234742
- 邮箱：deutschland@bitrialsupport.com
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy male or female of non-childbearing potential 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
- Aged 18 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 Further inclusion criteria apply.
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 outside the range of 50 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：随机化
- 介入模型：顺序分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：安慰剂组
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Placebo |
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实验性的：BI 3821001 treatment group
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BI 3821001 |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
大体时间：Up to 81 days
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Up to 81 days
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
大体时间：Up to 81 days
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Up to 81 days
|
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Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
大体时间：Up to 81 days
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Up to 81 days
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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 (估计的)
研究完成 (估计的)
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
- 2007-0003
- 2026-526877-41-00 (注册表标识符：CTIS (EU))
- U1111-1336-3575 (注册表标识符：WHO International Clinical Trials Registry Platform (ICTRP))
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
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研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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