NCT02183493已完成1 期
Relative Bioavailability of a 5 mg BI 1356 Tablet Administered With and Without Food to Healthy Male and Female Subjects in an Open, Randomised, Single Dose, Two-way Crossover, Phase I 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
- 32
- 主要终点
- Maximum measured concentration (Cmax) of BI 1356 in plasma
研究概览
简要总结
To investigate the food effect on the relative bioavailability and pharmacokinetics of a 5 mg BI 1356 tablet administered as a single dose
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females 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 deviating from normal and of clinical relevance. Repeated measurement of a systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
- •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 within one month or less than 10 half-lives of the respective drug prior to first study drug administration and during the trial except if a relevant interaction can be ruled out
- •Participation in another trial with an investigational drug within two months prior to first study 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 (average consumption of more than 20 g/day in females and 30 g/day in males)
- •Drug abuse
- •Blood donation (more than 100 mL within four weeks prior to the start of study)
- •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 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 torsades de points (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- •For female subjects:
- •Positive pregnancy test, pregnancy or planning to become pregnant during the study or within 2 months after study completion
- •No adequate contraception during the study and until 2 months after study completion, i.e. not any of the following: implants, injectables, combined oral contraceptives, intrauterine device (IUD) , sexual abstinence for at least 1 month prior to enrolment, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females, who do not have a vasectomised partner, are not sexually abstinent or surgically sterile will be asked to use an additional barrier method (e.g. condom, diaphragm with spermicide)
- •Lactation
研究组 & 干预措施
Fed administration of BI 1356
Experimental
干预措施: BI 1356 (Drug)
Fasted administration of BI 1356
Active Comparator
干预措施: BI 1356 (Drug)
结局指标
主要结局
Maximum measured concentration (Cmax) of BI 1356 in plasma
时间窗: up to 96 hours after start of treatment
Area under the concentration-time curve of BI 1356 in plasma over the time interval from 0 to 72 h (AUC0-72)
时间窗: up to 72 hours after start of treatment
次要结局
- Terminal half-life (t1/2) of BI 1356 in plasma(up to 96 hours after start of treatment)
- Number of patients with adverse events(up to 11 weeks)
- Area under the concentration-time curve of BI 1356 in plasma at different time points(up to 96 hours after start of treatment)
- Time from dosing to the maximum concentration (tmax) of BI 1356 in plasma(up to 96 hours after start of treatment)
- Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)(up to 96 hours after start of treatment)
- Terminal elimination rate constant (λz) in plasma(up to 96 hours after start of treatment)
- Mean residence time of BI 1356 in the body after oral administration (MRTpo)(up to 96 hours after start of treatment)
- Apparent clearance of BI 1356 in the plasma after extravascular administration (CL/F)(up to 96 hours after start of treatment)
- Assessment of tolerability on a 4-point scale by investigator(14 days after last study drug administration)
研究者
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