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单剂量 BI 425809 的安全性、耐受性和药代动力学

2026年5月8日 更新者：Boehringer Ingelheim

健康男性受试者（部分随机、单盲、安慰剂对照）单次增加口服剂量 BI 425809 的安全性、耐受性和药代动力学以及 BI 425809 的相对生物利用度和食物效应研究（开放标签、随机、三-方式交叉）

调查健康男性志愿者单次增加​​ BI 425809 剂量后 BI 425809 的安全性、耐受性和药代动力学；探讨BI 425809作为口服溶液的剂量比例性；研究 BI 425809 口服溶液禁食与 BI 425809 片剂禁食和片剂喂养的相对生物利用度

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

83

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

  • 德国
      • Ingelheim、德国
        • 1346.1.1 Boehringer Ingelheim Investigational Site

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 45年 (成人)

接受健康志愿者

是的

描述

纳入标准：

  • 健康男性受试者
  • 18至45岁（含）
  • 体重指数 (BMI) 18.5 至 29.9 kg/m2（含）
  • 受试者必须能够理解并遵守学习要求

排除标准：

  • 任何体格检查结果（包括血压 (BP)、脉率 (PR) 或心电图 (ECG)）偏离正常并由研究者判断为临床相关
  • 重复测量收缩压 <90 或 >140 mmHg，或舒张压 <50 或 >90 mmHg，或脉率 <50 或 >90
  • 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
  • 任何由研究者判断为临床相关的伴随疾病的证据
  • 胃肠道、肝脏、肾脏、呼吸系统、心血管、代谢、免疫或荷尔蒙失调
  • 可能干扰研究药物动力学的胃肠道手术
  • 中枢神经系统疾病（如癫痫）、其他神经系统疾病或精神疾病

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：交叉作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：SRD Part: Placebo
Participants received a single dose of oral solution of placebo matching BI 425809. SRD = Single Rising Dose.
药品：Placebo PfOS
Placebo as a powder for an oral solution (PfOS)
实验性的：SRD Part: 0.5 mg BI 425809
Participants received a single dose of oral solution containing 0.5 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
药品：BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
其他名称：
  • 伊可培汀
实验性的：SRD Part: 1 mg BI 425809
Participants received a single dose of oral solution containing 1 milligram (mg) of BI 425809. SRD = Single Rising Dose.
药品：BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
其他名称：
  • 伊可培汀
实验性的：SRD Part: 2 mg BI 425809
Participants received a single dose of oral solution containing 2 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
药品：BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
其他名称：
  • 伊可培汀
实验性的：SRD Part: 5 mg BI 425809
Participants received a single dose of oral solution containing 5 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
药品：BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
其他名称：
  • 伊可培汀
实验性的：SRD Part: 10 mg BI425809
Participants received a single dose of oral solution containing 10 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
药品：BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
其他名称：
  • 伊可培汀
实验性的：SRD Part: 25 mg BI 425809
Participants received a single dose of oral solution containing 25 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
药品：BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
其他名称：
  • 伊可培汀
实验性的：SRD Part: 50 mg BI 425809
Participants received a single dose of oral solution containing 50 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
药品：BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
其他名称：
  • 伊可培汀
实验性的：SRD Part: 100 mg BI 425809
Participants received a single dose of oral solution containing 100 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
药品：BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
其他名称：
  • 伊可培汀
实验性的：SRD Part: 150 mg BI 425809
Participants received a single dose of oral solution containing 150 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
药品：BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
其他名称：
  • 伊可培汀
实验性的：BA/FE Part: 25 mg BI 425809, R/T1/T2
Participants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R), 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), and 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect.
药品：BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
其他名称：
  • 伊可培汀
药品：BI 425809 tablet
BI 425809 as a tablet
其他名称：
  • 伊可培汀
实验性的：BA/FE Part: 25 mg BI 425809, R/T2/T1
Participants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R), 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), and 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect.
药品：BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
其他名称：
  • 伊可培汀
药品：BI 425809 tablet
BI 425809 as a tablet
其他名称：
  • 伊可培汀
实验性的：BA/FE Part: 25 mg BI 425809, T1/T2/R
Participants were administered 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), and 25 mg of BI 425809 as a tablet without food (reference treatment R). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect.
药品：BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
其他名称：
  • 伊可培汀
药品：BI 425809 tablet
BI 425809 as a tablet
其他名称：
  • 伊可培汀
实验性的：BA/FE Part: 25 mg BI 425809, T1/R/T2
Participants were administered 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), 25 mg of BI 425809 as a tablet without food (reference treatment R), and 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect.
药品：BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
其他名称：
  • 伊可培汀
药品：BI 425809 tablet
BI 425809 as a tablet
其他名称：
  • 伊可培汀
实验性的：BA/FE Part: 25 mg BI 425809, T2/T1/R
Participants were administered 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), and 25 mg of BI 425809 as a tablet without food (reference treatment R). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect.
药品：BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
其他名称：
  • 伊可培汀
药品：BI 425809 tablet
BI 425809 as a tablet
其他名称：
  • 伊可培汀
实验性的：BA/FE Part: 25 mg BI 425809, T2/R/T1
Participants were administered 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), 25 mg of BI 425809 as a tablet without food (reference treatment R), and 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect.
药品：BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
其他名称：
  • 伊可培汀
药品：BI 425809 tablet
BI 425809 as a tablet
其他名称：
  • 伊可培汀

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
Number of Participants With Drug-related Adverse Events (AE)
大体时间：SRD Part: From the time of first drug administration until the end of study, up to 18 days. BA/FE Part: From the time of first drug administration until the end of the intervention period, up to 18 days for each intervention.
Number of participants with drug-related Adverse Events (AE). Drug-relatedness was assessed by the investigator.
SRD Part: From the time of first drug administration until the end of study, up to 18 days. BA/FE Part: From the time of first drug administration until the end of the intervention period, up to 18 days for each intervention.

次要结果测量

结果测量
措施说明
大体时间
SRD Part: Maximum Concentration of BI 425809 in Plasma (Cmax)
大体时间：2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.
Maximum measured concentration of BI 425809 in plasma (Cmax) in the Single Rising Dose (SRD) part of the trial is reported.
2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.
BA/FE Part: Maximum Concentration of BI 425809 in Plasma (Cmax)
大体时间：2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.
Maximum measured concentration of BI 425809 in plasma (Cmax) in the bioavailability/food effect (BA/FE) part of the trial is reported.
2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.
SRD Part: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC(0-∞))
大体时间：2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC(0-∞)) in the Single Rising Dose (SRD) part of the trial is reported.
2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.
BA/FE Part: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC(0-∞))
大体时间：2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC(0-∞)) in the Bioavailability/Food Effect (BA/FE) part of the trial is reported.
2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.

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。

赞助

Boehringer Ingelheim

调查人员

  • 学习椅：Boehringer Ingelheim、Boehringer Ingelheim

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。

一般刊物

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)

2014年3月20日

初级完成 (实际的)

2014年9月10日

研究完成 (实际的)

2014年9月10日

研究注册日期

首次提交

2014年2月20日

首先提交符合 QC 标准的

2014年2月20日

首次发布 (估计的)

2014年2月21日

研究记录更新

最后更新发布 (实际的)

2026年6月3日

上次提交的符合 QC 标准的更新

2026年5月8日

最后验证

2026年5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

  • 1346.1
  • 2013-004937-34 (EudraCT编号：EudraCT)

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

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

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.

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