NCT02183662已完成1 期
Safety and Pharmacokinetics of Single Rising Oral Doses of BI 224436 ZW at 6.2 mg, 12.5 mg, 25 mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg and 1200 mg Dose Levels in Healthy Male Volunteers (Randomized, Double-blind, Placebo-controlled Within Dose Groups)
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
- 105
- 主要终点
- maximum measured concentration of the analyte in plasma
研究概览
简要总结
To investigate safety and pharmacokinetics of BI 224436 ZW
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 males
- •Age ≥21 and Age ≤50 years
- •Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
- •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) and 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
- •HIV infection and other 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 within 10 days prior to administration or during the trial
- •Participation in another trial with an investigational drug within one month 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 treatment period)
- •Any laboratory value outside the reference range that is of clinical relevance
- •A baseline prolongation of QT/QTc interval (e.g., a QTc interval ≥450 ms)
- •A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- •Bradycardia (PR <60 beats/min)
研究组 & 干预措施
BI 224436
Experimental
干预措施: BI 224436 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo to BI 224436 (Drug)
结局指标
主要结局
maximum measured concentration of the analyte in plasma
时间窗: up to 72 hours
area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 24
时间窗: up to 24 hours
次要结局
- apparent volume of distribution(up to 72 hours)
- mean residence time of the analyte in the body after single oral administration(up to 72 hours)
- amount of analyte that is eliminated in urine from the time point t0 to time point t4(up to 4 hours)
- amount of analyte that is eliminated in urine from the time point t8 to time point t12(from 8 to 12 hours)
- terminal half-life of the analyte in plasma(up to 72 hours)
- time from dosing to maximum measured concentration of the analyte in plasma(up to 72 hours)
- apparent clearance of the analyte in plasma(up to 72 hours)
- terminal rate constant in plasma(up to 72 hours)
- the last measurable concentration in the concentration-time profile(up to 72 hours)
- amount of analyte that is eliminated in urine from the time point t12 to time point t24(from 12 to 24 hours)
- fraction of analyte eliminated in urine from time point t0 to time point t24(up to 24 hours)
- area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity(up to 72 hours)
- minimum observed concentration at 24 hours(up to 24 hours)
- apparent volume of distribution during the terminal phase λz(up to 72 hours)
- the percentage of the Area under the concentration-time curve until infinity, that is determined by extrapolation(up to 72 hours)
- amount of analyte that is eliminated in urine from the time point t4 to time point t8(from 4 to 8 hours)
- the extrapolated Area under the curve from the time of the last measurable concentration in the concentration-time profile to infinity(up to 72 hours)
- renal clearance of the analyte from the time point t0 until the time point t24(up to 24 hours)
研究者
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