NCT02211924已完成1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (50 mg to 800 mg) of BI 44847 as Tablet(s) Administered to Healthy Male Subjects. A Randomised, Placebo-controlled (Within Dose Groups) and Double-blinded Trial
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Number of patients with clinically relevant changes in vital signs
研究概览
简要总结
Study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 44847 in Japanese healthy 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
- •Subjects will be healthy male volunteers who meet the criteria below:
- •Persons without clinically remarkable findings or clinically evident complications based on their concurrent illness, past medical history, physical examination, vital signs (blood pressure, pulse rate, and body temperature), 12-lead ECG, and laboratory test results
- •Persons who are 20 or older and 35 or younger
- •Persons with a BMI 18.5 kg/m2 or more and 25.0 kg/m2 less
- •Persons who are willing to participate in this trial before study initiation and who give their written consent in accordance with Good Clinical Practice
排除标准
- •Any finding of the medical examination (including BP, Pulse Rate (PR) 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 any drugs within 10 days prior to administration or during the trial
- •Participation in another trial with an investigational drug within four 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 that is of clinical relevance
- •Inability to comply with dietary regimen of study centre
- •A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome)
- •The use of concomitant medications that prolong the QT/QTc interval
- •Any ECG value outside of the reference range and of clinical relevance including, but not limited to QRS interval >120 ms
- •Elevated urinary glucose levels at screening (>15 mg/dl)
研究组 & 干预措施
BI 44847
Experimental
single rising dose
干预措施: BI 44847 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of patients with clinically relevant changes in vital signs
时间窗: up to day 7
Number of patients with clinically relevant finding in 12-lead electrocardiogram (ECG)
时间窗: up to day 7
Number of patients with clinically relevant changes in laboratory parameters
时间窗: up to day 7
Number of patients with adverse events
时间窗: up to 5 weeks
次要结局
- Cmax (maximum concentration of the analyte in plasma)(up to 48 hours after drug administration)
- tmax (time from dosing to maximum concentration)(up to 48 hours after drug administration)
- AUC0-inf. (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(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)
- AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)(up to 48 hours after drug administration)
- λz (terminal rate constant in plasma)(up to 48 hours after drug administration)
- t1/2 (terminal half-life of the analyte in plasma(up to 48 hours after drug administration)
- MRTpo (mean residence time of the analyte in the body after po administration)(up to 48 hours after drug administration)
- CL/F (total clearance of the analyte in the plasma after extravascular administration)(up to 48 hours after drug administration)
- Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)(up to 48 hours after drug administration)
- Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)(up to 48 hours after drug administration)
- fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)(up to 48 hours after drug administration)
- CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)(up to 48 hours after drug administration)
- Area under the plasma glucose concentration time curve(up to 12 hours after drug administration)
- Total amount of glucose excreted in the urine(up to 48 hours after drug administration)
- Maximum glucose concentration in plasma(up to 12 hours after drug administration)
- Maximum glucose concentration in urine(up to 48 hours after drug administration)
研究者
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