NCT02172170已完成1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (0.5 mg to 800 mg) of BI 10773 as Tablets Administered to Healthy Male Subjects. A Randomised Placebo-controlled (Within-dose Groups) and Double-blind Trial.
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
- 72
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
Study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses of BI 10773 to healthy male subjects.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males according to the following criteria:
- •Based upon a complete medical history, including the physical examination, vital signs ((blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
- •Age ≥ 18 and Age ≤ 50 years
- •BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
- •Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
排除标准
- •Any finding of the medical examination including ((blood pressure (BP), pulse rate (PR), 12-lead electrocardiogram (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 prior to administration or during the trial
- •Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- •Participation in another trial with an investigational drug within two 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)
- •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 the dietary regimen of trial site
- •A marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval >450 ms);
- •A history of additional risk factors for torsade de pointes (e.g. heart failure, hypokalemia, family history of Long QT Syndrome);
- •Exclusion criteria specific for this study:
- •Elevated urinary glucose levels at screening (> 15 mg/dl; > 0.83 mmol/L)
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
BI 10773 single rising dose
Experimental
干预措施: BI 10773 single rising dose (Drug)
结局指标
主要结局
Number of patients with adverse events
时间窗: up to 33 days
Number of patients with clinically significant changes in vital signs
时间窗: up to 12 days
Assessment of tolerability by investigator on a 4-point scale
时间窗: up to day 4
Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)
时间窗: up to 12 days
Number of patients with abnormal findings in physical examination
时间窗: up to 12 days
Number of patients with abnormal changes in laboratory parameters
时间窗: up to 12 days
次要结局
- Cmax (maximum concentration of the analyte in plasma)(up to 72 hours after drug administration)
- tmax (time from dosing to maximum concentration)(up to 72 hours after drug administration)
- AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(up to 72 hours after drug administration)
- %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)(up to 72 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 72 hours after drug administration)
- λz (terminal rate constant in plasma)(up to 72 hours after drug administration)
- t1/2 (terminal half-life of the analyte in plasma)(up to 72 hours after drug administration)
- MRTpo (mean residence time of the analyte in the body after po administration)(up to 72 hours after drug administration)
- CL/F (total clearance of the analyte in the plasma after extravascular administration)(up to 72 hours after drug administration)
- Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)(up to 72 hours after drug administration)
- Ae t1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)(up to 72 hours after drug administration)
- fe t1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)(up to 72 hours after drug administration)
- CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)(up to 72 hours after drug administration)
研究者
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