一项针对健康男性的研究，旨在测试不同剂量的 BI 3731579 的耐受性
2026年6月23日 更新者：Boehringer Ingelheim
一项部分随机、单盲、安慰剂对照试验，旨在研究以片剂形式向健康男性受试者施用单次剂量 BI 3731579 的安全性、耐受性和药代动力学
该试验的主要目的是研究 BI 3731579 在健康男性受试者中的安全性、耐受性和药代动力学 (PK)。
研究概览
研究类型
介入性
注册 (实际的)
63
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
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Biberach、德国、88397
- Humanpharmakologisches Zentrum Biberach
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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
- 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，健康男性受试者基于完整的病史，包括体格检查、生命体征（血压 (BP)、脉搏率 (PR)）、12 导联心电图 (ECG) 和临床实验室测试
- 年龄18周岁至45周岁（含）
- 体重指数 (BMI) 18.5 至 29.9 kg/m^2（含）
- 在参加试验之前，根据国际人用药品技术要求协调委员会 - 良好临床实践 (ICH-GCP) 和当地立法签署并注明日期的书面知情同意书
排除标准
- 体检（包括血压、PR 或心电图）中任何偏离正常值且经研究者评估为具有临床相关性的发现
- 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 mmHg 范围、或脉率超出 50 至 90 次/分钟 (bpm) 范围
- 研究者认为具有临床相关性的任何超出参考范围的实验室值
- 经研究者评估为临床相关的伴随疾病的任何证据 适用进一步的排除标准
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：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Dose group (DG) 1, 6 mg BI 3731579
DG 1 comprised participants who received a single oral dose of 6 milligrams (mg) BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
Participants received a single oral dose of BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
The doses received were respectively 6 mg (DG 1), 21 mg (DG 2), 60 mg (DG 3), 120 mg (DG 4), 210 mg (DG 5), 360 mg (DG 6), 480 mg (DG 7) and 600 mg (DG 8).
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实验性的：DG 2, 21 mg BI 3731579
DG 2 comprised participants who received a single oral dose of 21 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
Participants received a single oral dose of BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
The doses received were respectively 6 mg (DG 1), 21 mg (DG 2), 60 mg (DG 3), 120 mg (DG 4), 210 mg (DG 5), 360 mg (DG 6), 480 mg (DG 7) and 600 mg (DG 8).
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实验性的：DG 3, 60 mg BI 3731579
DG 3 comprised participants who received a single oral dose of 60 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
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Participants received a single oral dose of BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
The doses received were respectively 6 mg (DG 1), 21 mg (DG 2), 60 mg (DG 3), 120 mg (DG 4), 210 mg (DG 5), 360 mg (DG 6), 480 mg (DG 7) and 600 mg (DG 8).
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实验性的：DG 4, 120 mg BI 3731579
DG 4 comprised participants who received a single oral dose of 120 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
Participants received a single oral dose of BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
The doses received were respectively 6 mg (DG 1), 21 mg (DG 2), 60 mg (DG 3), 120 mg (DG 4), 210 mg (DG 5), 360 mg (DG 6), 480 mg (DG 7) and 600 mg (DG 8).
|
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实验性的：DG 5, 210 mg BI 3731579
DG 5 comprised participants who received a single oral dose of 210 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
Participants received a single oral dose of BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
The doses received were respectively 6 mg (DG 1), 21 mg (DG 2), 60 mg (DG 3), 120 mg (DG 4), 210 mg (DG 5), 360 mg (DG 6), 480 mg (DG 7) and 600 mg (DG 8).
|
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实验性的：DG 6, 360 mg BI 3731579
DG 6 comprised participants who received a single oral dose of 360 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
Participants received a single oral dose of BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
The doses received were respectively 6 mg (DG 1), 21 mg (DG 2), 60 mg (DG 3), 120 mg (DG 4), 210 mg (DG 5), 360 mg (DG 6), 480 mg (DG 7) and 600 mg (DG 8).
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实验性的：DG 7, 480 mg BI 3731579
DG 7 comprised participants who received a single oral dose of 480 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
Participants received a single oral dose of BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
The doses received were respectively 6 mg (DG 1), 21 mg (DG 2), 60 mg (DG 3), 120 mg (DG 4), 210 mg (DG 5), 360 mg (DG 6), 480 mg (DG 7) and 600 mg (DG 8).
|
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实验性的：DG 8, 600 mg BI 3731579
DG 8 comprised participants who received a single oral dose of 600 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
|
Participants received a single oral dose of BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
The doses received were respectively 6 mg (DG 1), 21 mg (DG 2), 60 mg (DG 3), 120 mg (DG 4), 210 mg (DG 5), 360 mg (DG 6), 480 mg (DG 7) and 600 mg (DG 8).
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安慰剂比较：Placebo
This group comprised all participants who received BI 3731579-matched placebo as film-coated tablets and as a single oral dose, with 240 milliliters (mL) of water following an overnight fast of at least 10 hours (hrs).
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Participants received BI 3731579-matched placebo as film-coated tablets and as a single oral dose, with 240 milliliters (mL) of water following an overnight fast of at least 10 hours (hrs).
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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 |
|---|---|---|
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Occurrence of Any Treatment-emergent Adverse Event (AE) Assessed as Drug-related by the Investigator
大体时间：From timepoint of drug administration plus the residual effect period, up to 4 days (96 hours) after drug administration.
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The occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator is reported.
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From timepoint of drug administration plus the residual effect period, up to 4 days (96 hours) after drug administration.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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AUC0-tz (Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point)
大体时间：Measured within 3 hours prior to drug administration and at 0.25 hours (hrs), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hrs after drug intake.
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AUC0-tz (area under the concentration-time curve of BI 3731579 in plasma over the time interval from 0 to the last quantifiable data point) is reported.
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Measured within 3 hours prior to drug administration and at 0.25 hours (hrs), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hrs after drug intake.
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AUC0-∞ (Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
大体时间：Measured within 3 hours prior to drug administration and at 0.25 hours (hrs), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hrs after drug intake.
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AUC0-∞ (area under the concentration-time curve of BI 3731579 in plasma over the time interval from 0 extrapolated to infinity) is reported.
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Measured within 3 hours prior to drug administration and at 0.25 hours (hrs), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hrs after drug intake.
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Cmax (Maximum Measured Concentration of BI 3731579 in Plasma)
大体时间：Measured within 3 hours prior to drug administration and at 0.25 hours (hrs), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hrs after drug intake.
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Cmax (maximum measured concentration of BI 3731579 in plasma) is reported.
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Measured within 3 hours prior to drug administration and at 0.25 hours (hrs), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hrs after drug intake.
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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)
2024年7月8日
初级完成 (实际的)
2025年5月19日
研究完成 (实际的)
2025年5月27日
研究注册日期
首次提交
2024年5月21日
首先提交符合 QC 标准的
2024年5月21日
首次发布 (实际的)
2024年5月24日
研究记录更新
最后更新发布 (实际的)
2026年8月10日
上次提交的符合 QC 标准的更新
2026年6月23日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- 1519-0001
- 2023-510318-25-00 (注册表标识符：CTIS)
- U1111-1304-0523 (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)？
不
IPD 计划说明
由勃林格殷格翰赞助的临床研究，第一期至第四期，介入性和非介入性，均属于原始临床研究数据和临床研究文件共享的范围。 可能存在例外情况，例如 研究勃林格殷格翰不是许可证持有者的产品；有关药物配方和相关分析方法的研究，以及使用人体生物材料进行药代动力学的研究；在单一中心进行的研究或针对罕见疾病的研究（在患者数量较少且因此匿名化受到限制的情况下）。
更多详情请参阅：
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
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.