Safety, Tolerability and Pharmacokinetics of Single Rising Intravenous Doses of BI 44370 BS Solution in Healthy Male Volunteers
2014年8月12日 更新者:Boehringer Ingelheim
Safety, Tolerability and Pharmacokinetics of Single Rising Intravenous Doses (10 to 50 mg) of BI 44370 BS Solution in Healthy Male Volunteers (Randomised, Single-blind, Placebo-controlled Within Dose Groups, Phase I)
Study to investigate safety, tolerability, and pharmacokinetics of BI 44370 BS solution for intravenous (i.v.) infusion
研究概览
研究类型
介入性
注册 (实际的)
23
阶段
- 阶段1
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
21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:
- Healthy males according to the following criteria based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR), Respiratory Rate (RR) and body temperature), 12-lead ECG, clinical laboratory tests
- Age 21 to 50 years inclusive
- Body Mass Index (BMI) 18.5 to 29.9 kg/m2 inclusive
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and German law
Exclusion Criteria:
- Any finding of the medical examination (including BP, PR, RR, body temperature and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
- A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- Not willing to use adequate contraception (condom use plus another form of contraception, e.g. spermicide, oral contraceptive taken by female partner, sterilisation, or intrauterine device) during the whole study period from the time of the first intake of study drug until three months after the last intake
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 |
---|---|
安慰剂比较:安慰剂
|
|
实验性的:BI 44370
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Number of patients with clinically significant findings in vital signs
大体时间:up to 16 days
|
up to 16 days
|
Number of patients with clinically significant findings in 12-lead electrocardiogram (ECG)
大体时间:up to 16 days
|
up to 16 days
|
Number of patients with clinically significant laboratory findings
大体时间:up to 16 days
|
up to 16 days
|
Number of patients with adverse events
大体时间:up to 37 days
|
up to 37 days
|
Assessment of global tolerability by investigator on a 4-point scale
大体时间:within 14 days after last trial procedure
|
within 14 days after last trial procedure
|
次要结果测量
结果测量 |
大体时间 |
---|---|
AUC0-∞(血浆中分析物在从 0 外推到无穷大的时间间隔内的浓度-时间曲线下面积)
大体时间:给药后最多 24 小时
|
给药后最多 24 小时
|
Cmax(血浆中分析物的最大测量浓度)
大体时间:给药后最多 24 小时
|
给药后最多 24 小时
|
tmax(从给药到最大测量浓度的时间)
大体时间:给药后最多 24 小时
|
给药后最多 24 小时
|
λz(血浆中的终末速率常数)
大体时间:给药后最多 24 小时
|
给药后最多 24 小时
|
t1/2(分析物在血浆中的终末半衰期)
大体时间:给药后最多 24 小时
|
给药后最多 24 小时
|
AUC0-tz(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浓度-时间曲线下的面积)
大体时间:给药后最多 24 小时
|
给药后最多 24 小时
|
%AUCtz-∞(外推得到的AUC0-∞的百分比)
大体时间:给药后最多 24 小时
|
给药后最多 24 小时
|
CLR,t1-t2(分析物从时间点 t1 到时间点 t2 的肾脏清除率)
大体时间:给药后最多 24 小时
|
给药后最多 24 小时
|
AUC0-2 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 2 hours after drug application)
大体时间:up to 2 hours after drug administration
|
up to 2 hours after drug administration
|
AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from time point t1 to time point t2)
大体时间:up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
MRTinf (mean residence time of the analyte in the body after intravenous administration)
大体时间:up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
CL (total clearance of the analyte in plasma after intravascular administration)
大体时间:up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
Vz (apparent volume of distribution during the terminal phase λz following an intravascular dose)
大体时间:up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
Vss (apparent volume of distribution at steady state following intravascular administration)
大体时间:up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
大体时间:up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
大体时间:up to 24 hours after drug administration
|
up to 24 hours 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。
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
2008年9月1日
初级完成 (实际的)
2008年11月1日
研究注册日期
首次提交
2014年8月12日
首先提交符合 QC 标准的
2014年8月12日
首次发布 (估计)
2014年8月13日
研究记录更新
最后更新发布 (估计)
2014年8月13日
上次提交的符合 QC 标准的更新
2014年8月12日
最后验证
2014年8月1日
更多信息
与本研究相关的术语
其他研究编号
- 1246.12
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.
安慰剂的临床试验
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的