NCT02172105已完成1 期
A Double-blind, Randomised, Placebo Controlled (Within a Dose Group) Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Rising Inhalative Doses (5 μg, 10 μg and 20 μg) of BI 1744 CL for 14 Days in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Number of patients with abnormal findings in physical examination
研究概览
简要总结
Study to evaluate safety, tolerability, and pharmacokinetics of BI 1744 CL in healthy Japanese male volunteers.
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
- 20 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese men: According to the results of a complete medical history, the physical examination, vital signs (blood pressure and pulse rate), 12-lead ECG, clinical laboratory tests
- •Age ≥20 and ≤35 years
- •Body mass index (BMI) ≥18.5 and ≤25.0 kg/m2
- •Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
- •Subjects must be able to inhale medication in a competent manner from the Respimat®inhaler
排除标准
- •Any finding of the medical examination (including ,blood pressure and pulse rate 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
- •Surgery of the gastrointestinal tract (except appendectomy)
- •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 before drug administration or during the trial
- •Use of prescription or non-prescription drugs within 10 days before drug administration or during the trial. However, over-the-counter drugs for external application (such as lubricant eye drops for contact lens, insect bite reliever) shall be allowed
- •Participation in another trial with an investigational drug within four months before drug 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: corresponds to ca. 3 large bottles of beer, 3 gous (ca. 540 cc) of Japanese sake, 6 shots of whisky, 6 glasses of wine or 6 glasses of Japanese shochu, distilled alcoholic beverage)
- •Drug abuse
- •Blood donation (more than 100 mL within four weeks before drug administration or during the trial)
- •Excessive physical activities (within one week before administration or during the trial)
- •Any laboratory value outside the reference range that is of clinical relevance
- •Inability to comply with dietary regimen of trial site
- •A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms) or long QT syndroms
- •A history of additional risk factors for torsades de pointes (TdP) (e.g., heart failure, hypokalemia) or other cardiac arrhythmias
- •hyperthyroidism
- •Disagree with adequate contraception (the subject should use condoms and his partner should use oral contraception or intrauterine device [IUD]) during the study
研究组 & 干预措施
BI 1744 CL
Experimental
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
Number of patients with abnormal findings in physical examination
时间窗: Baseline, up to 13 days after last drug administration
Number of patients with clinically relevant findings in vital signs (blood pressure, pulse rate)
时间窗: Baseline, up to 13 days after last drug administration
Number of patients with abnormal findings in 12-lead electrocardiogram (ECG)
时间窗: Baseline, up to 13 days after last drug administration
Number of patients with clinically significant changes in clinical laboratory tests
时间窗: Baseline, up to 13 days after last drug administration
Change from baseline in potassium level
时间窗: Baseline and Day 14
Number of patients with adverse events
时间窗: 7 weeks
Assessment of tolerability on a 4-point scale
时间窗: Day 28
次要结局
- Cmax (maximum measured concentration of the analyte in plasma at different time points)(Up to day 18)
- tmax (time from dosing to maximum measured concentration of the analyte in plasma at different time points)(Up to day 18)
- AUC (area under the concentration-time curve of the analyte in plasma at different time points)(Up to day 18)
- %AUCtz-∞ (the percentage of the AUC 0-infinity that is obtained by extrapolation)(Up to day 18)
- λz (terminal rate constant in plasma at different time points)(Up to day 18)
- t1/2 (terminal half-life of the analyte in plasma at different time points)(Up to day 18)
- MRTih (mean residence time of the analyte in the body after inhalation administration at different time points)(Up to day 18)
- Aeτ (amount of analyte that is eliminated in urine after administration over a uniform dosing interval τ at different time points)(Up to day 18)
- feτ (fraction of analyte eliminated in urine after administration over a uniform dosing interval τ at different time points)(Up to day 18)
- CLR (renal clearance of the analyte at different time points)(Up to day 18)
- Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)(Up to day 18)
- Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)(Up to day 18)
- AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)(Up to day 18)
- CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration)(Up to day 18)
- Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)(Up to day 18)
- Accumulation ratio (RA,AUC)(Up to day 18)
- Accumulation ratio (RA,Cmax)(Up to day 18)
研究者
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