Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 14332 CL Powder in Healthy Male Subjects
2014年8月7日 更新者:Boehringer Ingelheim
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (0.5 mg to 200 mg) of BI 14332 CL as Powder in the Bottle Reconstituted With 0.1% Tartaric Acid Administered to Healthy Male Subjects. A Randomised and Placebo-controlled Trial, Double Blinded Within Dose Groups
To investigate safety, tolerability and pharmacokinetics, and pharmacodynamics of BI 14332 CL
研究概览
研究类型
介入性
注册 (实际的)
53
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
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:
- Healthy males were included based on a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, and clinical laboratory tests
- Age ≥18 and Age ≤50 years
- Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Exclusion Criteria:
- Any finding of the medical examination (including BP, HR 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 drugs which reasonably influenced the results of the trial 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 and of clinical relevance
- Inability to comply with the dietary regimen of the study centre
- Any ECG value outside the reference range and of clinical relevance including, but not limited to QRS interval >120 ms or a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms or QT >500 ms)
- A history of additional risk factors for Torsades des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- The use of concomitant medications that prolong the QT/QTc interval
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 14332 CL
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 |
---|---|
Number of patients with adverse events
大体时间:up to day 16
|
up to day 16
|
Number of patients with clinically significant findings in vital signs (blood pressure, heart rate)
大体时间:up to day 16
|
up to day 16
|
Number of patients with clinically significant findings ECG
大体时间:up to day 16
|
up to day 16
|
Number of patients with clinically significant findings laboratory tests
大体时间:up to day 16
|
up to day 16
|
Assessment of global tolerability by investigator on a 4-point scale
大体时间:within 9 to 16 days after drug administration
|
within 9 to 16 days after drug administration
|
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:给药后长达 192 小时
|
给药后长达 192 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:给药后长达 192 小时
|
给药后长达 192 小时
|
λz(血浆中的终末速率常数)
大体时间:给药后长达 192 小时
|
给药后长达 192 小时
|
t1/2(分析物在血浆中的终末半衰期)
大体时间:给药后长达 192 小时
|
给药后长达 192 小时
|
MRTpo(口服给药后分析物在体内的平均停留时间)
大体时间:给药后长达 192 小时
|
给药后长达 192 小时
|
Vz/F(血管外剂量后末期 λz 期间的表观分布容积)
大体时间:给药后长达 192 小时
|
给药后长达 192 小时
|
Cmax (maximum concentration of the analyte in plasma)
大体时间:up to 192 hours after drug administration
|
up to 192 hours after drug administration
|
tmax (time from dosing to maximum concentration)
大体时间:up to 192 hours after drug administration
|
up to 192 hours after drug administration
|
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
大体时间:up to 192 hours after drug administration
|
up to 192 hours after drug administration
|
CL/F (total clearance of the analyte in the plasma after extravascular administration)
大体时间:up to 192 hours after drug administration
|
up to 192 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 120 hours after drug administration
|
up to 120 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 120 hours after drug administration
|
up to 120 hours after drug administration
|
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
大体时间:up to 120 hours after drug administration
|
up to 120 hours after drug administration
|
Change in Dipeptidyl peptidase IV (DDP-IV) activity
大体时间:up to 192 hours after drug administration
|
up to 192 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
2006年2月1日
初级完成 (实际的)
2006年4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
- 1233.1
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
-
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