Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BI 1744 CL in Healthy Male and Female Volunteers
2014年6月20日 更新者:Boehringer Ingelheim
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses (2.5 μg, 10 μg, and 30 μg) of BI 1744 CL for 14 Days in Healthy Male and Female Volunteers (Doubleblind, Randomised, Placebo Controlled [at Each Dose Level] Study)
To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1744 CL
研究概览
研究类型
介入性
注册 (实际的)
47
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
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Healthy male or female based upon a complete medical history, including the physical examination, regarding vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease.
- Age ≥21 and ≤50 years
- BMI ≥18.5 and <30 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Exclusion Criteria:
- Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
- 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 the drug or its excipients) as judged clinically relevant by the investigator
- Intake of drugs with a long half-life (>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomisation
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to randomisation
- Participation in another trial with an investigational drug within 2 months prior to randomisation
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- Inability to refrain from smoking on trial days as judged by the investigator
- Alcohol abuse (more than 60 g alcohol a day)
- Drug abuse
- Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)
- Excessive physical activities within 1 week prior to randomisation or during the trial
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of the study centre
The following exclusion criteria are specific for this study due to the known class side effect profile of ß2-mimetics:
- Asthma or history of pulmonary hyperreactivity
- Hyperthyrosis
- Allergic rhinitis in need of treatment
- Clinically relevant cardiac arrhythmia
- Paroxysmal tachycardia (>100 beats per minute).
For female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception e.g. oral contraception, sterilisation, IUD (intrauterine device). Females who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condoms) prior to administration of study medication, during the study and at least 2 months after release from the study.
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
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 1744 CL multiple rising doses
|
|
实验性的:BI 1744 CL medium dose, females
|
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 changes in physical examination
大体时间:Baseline, day 32 (end-of-study examination)
|
Baseline, day 32 (end-of-study examination)
|
Number of patients with clinically significant changes in vital signs
大体时间:Baseline, up to day 32
|
Baseline, up to day 32
|
Number of patients with clinically significant changes in 12-lead ECG (Electrocardiogram)
大体时间:Baseline, up to day 32
|
Baseline, up to day 32
|
Number of patients with abnormal changes in laboratory tests
大体时间:Baseline, up to day 32
|
Baseline, up to day 32
|
Changes in airway resistance (Raw) measured by body plethysmography
大体时间:Baseline, up to day 32
|
Baseline, up to day 32
|
Changes in tremormetry parameters
大体时间:Baseline, up to day 32
|
Baseline, up to day 32
|
Number of patients with adverse events
大体时间:Up to day 32
|
Up to day 32
|
Assessment of tolerability by the investigator on a 4-point scale
大体时间:Day 32 (end-of-study examination)
|
Day 32 (end-of-study examination)
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Cmax (maximum concentration of the analyte in plasma)
大体时间:Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
tmax (time from dosing to maximum concentration)
大体时间:Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
AUC (area under the concentration-time curve of the analyte in plasma at different time points)
大体时间:Up to 408 hours after drug administration
|
Up to 408 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 384 hours after drug administration
|
Up to 384 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 384 hours after drug administration
|
Up to 384 hours after drug administration
|
%AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation)
大体时间:Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
λz (terminal rate constant of the analyte in plasma)
大体时间:Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
t½ (terminal half-life of the analyte in plasma)
大体时间:Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
MRTih (mean residence time of the analyte in the body after inhalation)
大体时间:Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
大体时间:Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
Vz/F (apparent volume of distribution of the analyte during the terminal phase λz following an extravascular dose)
大体时间:Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
CLR,t1-t2 (renal clearance of the analyte in plasma from the time point t1 until the time point t2)
大体时间:Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
RA,Cmax,14 based on Cmax (Accumulation ratio of the analyte in plasma after multiple dose administration over a uniform dosing interval τ)
大体时间:Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
RA,AUC,14 based on AUC0-τ
大体时间:Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
大体时间:Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
大体时间:Up to 408 hours after drug administration
|
Up to 408 hours after drug administration
|
Linearity Index (LI)
大体时间:Up to 408 hours after drug administration
|
Up to 408 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1月1日
初级完成 (实际的)
2006年9月1日
研究注册日期
首次提交
2014年6月20日
首先提交符合 QC 标准的
2014年6月20日
首次发布 (估计)
2014年6月24日
研究记录更新
最后更新发布 (估计)
2014年6月24日
上次提交的符合 QC 标准的更新
2014年6月20日
最后验证
2014年6月1日
更多信息
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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