NCT02172131终止1 期
Safety, Tolerability and Pharmacokinetics of Single Rising Doses of 0.5 μg, 2.5 μg, 5 μg, 10 μg, 15 μg, 20 μg, 25 μg and 30 μg BI 1744 CL (Calculated as Free Base) Given as Intravenous Infusion Over 30 Minutes to Healthy Male Subjects. A Single-centre, Single-blind, Placebo-controlled, Randomised Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 64
- 主要终点
- Assessment of tolerability by investigator on a 4-point scale
研究概览
简要总结
To investigate safety, tolerability, and pharmacokinetics (PK) of single i.v. doses of BI 1744 CL
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
- Single
入排标准
- 年龄范围
- 21 Years 至 45 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 (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 ≤45 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
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 medication
- •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 medication
- •Participation in another trial with an investigational drug within 2 months prior to medication
- •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 medication 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 1744 CL
Experimental
Single rising dose of BI 1744 CL as intravenous (i.v.) infusion
干预措施: BI 1744 CL (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Assessment of tolerability by investigator on a 4-point scale
时间窗: Day 10 after drug administration
Number of patients with clinically significant changes in vital signs
时间窗: Baseline and up to day 10 after drug administration
Number of patients with abnormal changes in 12-lead ECG (electrocardiogram) parameters
时间窗: Baseline and up to day 10 after drug administration
Number of patients with abnormal findings in physical examination
时间窗: Baseline, Day 10 after drug administration
Number of patients with abnormal changes in laboratory parameters
时间窗: Baseline and up to day 10 after administration
Number of patients with adverse events
时间窗: Up to day 10
次要结局
- t1/2 (terminal half-life of the analyte in plasma)(Up to 48 hours after drug administration)
- AUC (area under the concentration-time curve of the analyte in plasma at different time points)(Up to 48 hours after drug administration)
- Cmax (maximum measured concentration of the analyte in plasma)(Up to 48 hours after drug administration)
- tmax (time from dosing to maximum measured concentration)(Up to 48 hours after drug administration)
- %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)(Up to 48 hours after drug administration)
- λz (terminal rate constant in plasma)(Up to 48 hours after drug administration)
- MRT (mean residence time of the analyte in the body after intravenous administration)(Up to 48 hours after drug administration)
- CL (total clearance of the analyte in plasma after intravascular administration)(Up to 48 hours after drug administration)
- V (apparent volume of distribution at different time points following an intravascular dose)(Up to 48 hours after drug administration)
- Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)(Up to 96 hours after drug administration)
- fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)(Up to 96 hours after drug administration)
- CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)(Up to 96 hours after drug administration)
研究者
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