Safety Tolerability and Pharmacokinetic of BI 411034
2017年7月5日 更新者：Boehringer Ingelheim
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 411034 (PIB) in Healthy Male Volunteers (Randomised, Single-blind, Placebocontrolled Within Dose Groups, Phase I Study)
The primary objective of the current study is to investigate the safety, tolerability and pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of single rising doses.
The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19 (Cytochrome P450) genotyped extensive metabolisers (EM).
Another objective is to compare the safety and pharmacokinetic profiles between two different groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)
研究概览
研究类型
介入性
注册 (实际的)
62
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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Ingelheim、德国
- 1308.1.1 Boehringer Ingelheim Investigational Site
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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
18年 至 50年 (成人)
接受健康志愿者
是的
有资格学习的性别
男性
描述
Inclusion criteria:
1. Healthy male subjects
Exclusion criteria:
1. Any relevant deviation from healthy conditions
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：单组作业
- 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
口服溶液
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口服溶液
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实验性的：BI 411034 low dose - group 1
Solution for oral administration
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Low dose solution for oral administration
Medium dose solution for oral administration
High dose solution for oral administration
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实验性的：BI 411034 low dose - group 2
Solution for oral administration
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Low dose solution for oral administration
Medium dose solution for oral administration
High dose solution for oral administration
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实验性的：BI 411034 medium dose - group 3
Solution for oral administration
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Low dose solution for oral administration
Medium dose solution for oral administration
High dose solution for oral administration
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实验性的：BI 411034 medium dose - group 4
Solution for oral administration
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Low dose solution for oral administration
Medium dose solution for oral administration
High dose solution for oral administration
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实验性的：BI 411034 medium dose - group 5
Solution for oral administration
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Low dose solution for oral administration
Medium dose solution for oral administration
High dose solution for oral administration
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实验性的：BI 411034 high dose - group 6
Solution for oral administration
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Low dose solution for oral administration
Medium dose solution for oral administration
High dose solution for oral administration
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实验性的：BI 411034 high dose - group 7
Solution for oral administration
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Low dose solution for oral administration
Medium dose solution for oral administration
High dose solution for oral administration
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实验性的：BI 411034 high dose - group 8
Solution for oral administration
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Low dose solution for oral administration
Medium dose solution for oral administration
High dose solution for oral administration
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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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Number of Participants With Drug Related AEs
大体时间：From drug administration until end of trial examination, up to 13 days
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Number of participants with drug related adverse events (AEs)
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From drug administration until end of trial examination, up to 13 days
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Clinically Relevant Abnormalities for Physical Examinations, Vital Signs, ECG, Laboratory Tests
大体时间：From drug administration until end of trial examination, up to 13 days
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Clinically relevant abnormalities for physical examinations, vital signs (blood pressure, pulse rate, oral body temperature, orthostasis test), 12-lead electrocardiogram (ECG) and clinical laboratory tests.
Clinically relevant abnormalities are reported by the investigator as adverse events (AEs).
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From drug administration until end of trial examination, up to 13 days
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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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Maximum Measured Concentration (Cmax )
大体时间：2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
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Maximum measured concentration of the analyte (BI 411034) in plasma
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2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
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Time to Maximum Measured Concentration (Tmax)
大体时间：2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
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Time from dosing to maximum measured concentration
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2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
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Area Under the Curve From 0 Extrapolated to Infinity (AUC0-infinity)
大体时间：2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
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Area under the concentration-time curve of the analyte (BI 411034) in plasma over the time interval from 0 extrapolated to infinity
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2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
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Amount of Analyte Eliminated in Urine From 0h to 4h (Ae0-4)
大体时间：2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
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Amount of analyte (BI 411034) eliminated in urine from the time point 0h to time point 4h.
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2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
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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)
2012年4月1日
初级完成 (实际的)
2012年8月1日
研究完成 (实际的)
2012年8月1日
研究注册日期
首次提交
2012年4月19日
首先提交符合 QC 标准的
2012年4月19日
首次发布 (估计)
2012年4月20日
研究记录更新
最后更新发布 (实际的)
2017年8月15日
上次提交的符合 QC 标准的更新
2017年7月5日
最后验证
2017年7月1日
更多信息
与本研究相关的术语
其他研究编号
- 1308.1
- 2011-004840-23 (EudraCT编号：EudraCT)
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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