A Randomised, Double-blind, Placebo-controlled (Within Dose Groups) Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses (0.5 μg to 70 μg Administered With the Respimat®) of BI 11054 CL in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 主要终点
- Number of subjects with clinically significant findings in physical examination
研究概览
简要总结
To investigate safety, tolerability, and pharmacokinetics of BI 11054
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male based upon a complete medical history, including the physical examination, regarding vital signs (BP, 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
- •Body mass index (BMI) ≥18.5 and <30 kg/m2
- •Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
排除标准
- •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 40 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)
研究组 & 干预措施
BI 11054 CL
干预措施: BI 11054 CL (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with clinically significant findings in physical examination
时间窗: up to 18 days after drug administration
Number of subjects with clinically significant findings in additional safety laboratory tests
时间窗: up to 24 hours after drug administration
cyclic adenosine monophosphate (cAMP) and potassium
Number of subjects with clinically significant findings in vital signs
时间窗: up to 18 days after drug administration
blood pressure (BP), pulse rate (PR), respiratory rate (RR)
Global tolerability assessed by investigator on a 4-point scale
时间窗: up to 18 days after drug administration
Number of subjects with clinically significant findings in orthostasis tests
时间窗: up to 24 hours after drug administration
Number of subjects with clinically significant findings in laboratory tests
时间窗: up to 18 days after drug administration
Number of subjects with adverse events
时间窗: up to 18 days after drug administration
Number of subjects with findings of pulmonary auscultation
时间窗: up to 24 hours after drug administration
Airway resistance (Raw)
时间窗: up to 24 hours after drug administration
measured by body plethysmography
Number of subjects with clinically significant changes in body temperature
时间窗: up to 24 hours after drug administration
Number of subjects with clinically significant findings in electrocardiogram (ECG)
时间窗: up to 18 days after drug administration
Number of subjects with findings of oropharyngeal inspection
时间窗: up to 24 hours after drug administration
次要结局
- Cmax (maximum measured concentration of the analyte in plasma)(up to 96 hours)
- AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable analyte plasma concentration)(up to 96 hours)
- MRTih (mean residence time of the analyte in the body after inhalation)(up to 96 hours)
- tmax (time from dosing to maximum measured concentration)(up to 96 hours)
- AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from time t1 to time t2)(up to 96 hours)
- AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(up to 96 hours)
- %AUCtz-∞ (percentage of the AUCtz-∞ that is obtained by extrapolation)(up to 96 hours)
- CL/F (apparent clearance of the analyte in plasma after extravascular administration)(up to 96 hours)
- λz (terminal rate constant in plasma)(up to 96 hours)
- t1/2 (terminal half-life of the analyte in plasma)(up to 96 hours)
- Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)(up to 96 hours)
- CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)(up to 96 hours)
- Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)(up to 96 hours)
- fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)(up to 96 hours)