Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 44847 Administered to Healthy Male Subjects
2014年8月7日 更新者:Boehringer Ingelheim
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (50 mg to 800 mg) of BI 44847 as Tablet(s) Administered to Healthy Male Subjects. A Randomised, Placebo-controlled (Within Dose Groups) and Double-blinded Trial
Study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 44847 in Japanese healthy volunteers
研究概览
研究类型
介入性
注册 (实际的)
48
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
20年 至 35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:
Subjects will be healthy male volunteers who meet the criteria below:
- Persons without clinically remarkable findings or clinically evident complications based on their concurrent illness, past medical history, physical examination, vital signs (blood pressure, pulse rate, and body temperature), 12-lead ECG, and laboratory test results
- Persons who are 20 or older and 35 or younger
- Persons with a BMI 18.5 kg/m2 or more and 25.0 kg/m2 less
- Persons who are willing to participate in this trial before study initiation and who give their written consent in accordance with Good Clinical Practice
Exclusion Criteria:
- Any finding of the medical examination (including BP, Pulse Rate (PR) 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
- 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 any drugs within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within four 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 study centre 19. A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome)
- The use of concomitant medications that prolong the QT/QTc interval
- Any ECG value outside of the reference range and of clinical relevance including, but not limited to QRS interval >120 ms
- Elevated urinary glucose levels at screening (>15 mg/dl)
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:双倍的
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 44847
single rising dose
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
发生不良事件的患者人数
大体时间:长达 5 周
|
长达 5 周
|
Number of patients with clinically relevant changes in vital signs
大体时间:up to day 7
|
up to day 7
|
Number of patients with clinically relevant finding in 12-lead electrocardiogram (ECG)
大体时间:up to day 7
|
up to day 7
|
Number of patients with clinically relevant changes in laboratory parameters
大体时间:up to day 7
|
up to day 7
|
次要结果测量
结果测量 |
大体时间 |
---|---|
λz(血浆中的终末速率常数)
大体时间:给药后最多 48 小时
|
给药后最多 48 小时
|
Vz/F(血管外给药后终末期 λz 的表观分布容积)
大体时间:给药后最多 48 小时
|
给药后最多 48 小时
|
fet1-t2(从时间点 t1 到时间点 t2 尿液中消除的分析物的分数)
大体时间:给药后最多 48 小时
|
给药后最多 48 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 48 小时
|
给药后最多 48 小时
|
%AUCtz-∞(外推得到的AUC0-∞的百分比)
大体时间:给药后最多 48 小时
|
给药后最多 48 小时
|
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
大体时间:up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
Cmax (maximum concentration of the analyte in plasma)
大体时间:up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
tmax (time from dosing to maximum concentration)
大体时间:up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
AUC0-inf. (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
大体时间:up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
t1/2 (terminal half-life of the analyte in plasma
大体时间:up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
MRTpo (mean residence time of the analyte in the body after po administration)
大体时间:up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
CL/F (total clearance of the analyte in the plasma after extravascular administration)
大体时间:up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
大体时间:up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
Area under the plasma glucose concentration time curve
大体时间:up to 12 hours after drug administration
|
up to 12 hours after drug administration
|
Total amount of glucose excreted in the urine
大体时间:up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
Maximum glucose concentration in plasma
大体时间:up to 12 hours after drug administration
|
up to 12 hours after drug administration
|
Maximum glucose concentration in urine
大体时间:up to 48 hours after drug administration
|
up to 48 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
2007年8月1日
初级完成 (实际的)
2007年9月1日
研究注册日期
首次提交
2014年8月7日
首先提交符合 QC 标准的
2014年8月7日
首次发布 (估计)
2014年8月8日
研究记录更新
最后更新发布 (估计)
2014年8月8日
上次提交的符合 QC 标准的更新
2014年8月7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
- 1224.11
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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City of Hope Medical CenterNational Cancer Institute (NCI)主动,不招人造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病,BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病,BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
-
Mila (bMotion Technologies)完全的
-
Universidad Autonoma de MadridCentro Universitario La Salle完全的