NCT02171767已完成1 期
Pharmacokinetics, Safety and Tolerability of BIBW 2992 Administered Orally as 20 mg, 30 mg, 40 mg, and 50 mg Tablets (Final Formulation) to Healthy Male Volunteers in an Open-label, Single Rising Dose, 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
- 48
- 主要终点
- Cmax (maximum measured concentration of the analyte in plasma)
研究概览
简要总结
Study to assess pharmacokinetics incl. dose proportionality, safety and tolerability of 4 different dosage strengths of BIBW 2992 tablets (final formulation of 20 mg, 30 mg, 40 mg, 50 mg) administered as single doses to healthy male volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males according to a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
- •Age 21 to 55 years, inclusive
- •Body mass index 18.5 to 29.9 kg/m2, inclusive
- •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), Puse 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
- •Chronic or relevant acute infections
- •History of relevant allergy/hypersensitivity (including drug allergy or its excipients)
- •Intake of drugs with a long half-life (>24 hours) within 1 month prior to administration of the trial drug or during the trial
- •Use of any drugs (including herbal preparations, vitamins and nutrient supplements) within 10 days prior to administration of the trial drug or during the trial
- •Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
- •Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- •Inability to refrain from smoking within the in-house periods from 12 hours before until 25 hours after each administration of the trial drug
- •Alcohol abuse (more than 30 g/day)
- •Drug abuse
- •Blood donation (more than 100 mL within 4 weeks prior to administration of the trial drug or during the trial)
- •Excessive physical activities (within 1 week prior to administration of the trial drug 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
- •Exclusion criteria specific for this study:
- •History of clinically relevant skin diseases, psoriasis or moderate/severe acne
- •History or evidence of interstitial lung disease
- •Males who are unwilling to use a medically acceptable method of contraception during the first 3 months after administration of the trial drug. Acceptable methods of contraception for use by male volunteers include sexual abstinence, a vasectomy performed at least 1 year prior to dosing, barrier contraception or another medically accepted contraceptive method
研究组 & 干预措施
BIBW 2992 MA2 - single rising dose
Experimental
干预措施: BIBW 2992 MA2 - single rising dose (Drug)
结局指标
主要结局
Cmax (maximum measured concentration of the analyte in plasma)
时间窗: predose, up to120 h 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)
时间窗: predose, up to 120 h after drug administration
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
时间窗: predose, up to 120 h after drug administration
次要结局
- %AUCtz-∞ (percentage of the AUCtz-∞ obtained by extrapolation from the last quantifiable data point to infinity)(predose, up to 120 h after drug administration)
- AUC0-24 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 [predose] to 24 h)(predose, up to 120 h after drug administration)
- MRTpo (mean residence time of the analyte in the body after oral administration)(predose, up to 120 h after drug administration)
- CL/F (apparent clearance of the analyte in plasma after extravascular administration)(predose, up to 120 h after drug administration)
- tmax (time from dosing to the maximum concentration of the analyte in plasma)(predose, up to 120 h after drug administration)
- λz (terminal rate constant of the analyte in plasma)(predose, up to 120 h after drug administration)
- t1/2 (terminal half-life of the analyte in plasma)(predose, up to 120 h days after drug administration)
- Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)(predose, up to 120 h after drug administration)
- Number of patients with abnormal findings in physical examination(Screening, up to 20 days after drug administration)
- Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)(Screening, up to 20 days after drug administration)
- Number of patients with abnormal changes in laboratory parameters(Screening, up to 20 days after drug administration)
- Number of patients with adverse events(up to 41 days)
- Assessment of tolerability by investigator on a 4-point scale(up to 20 days after drug administration)
- Number of patients with abnormal changes in 12-lead electrocardiogram (ECG)(Screening, up to 20 days after drug administration)
研究者
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