NCT02214901已完成1 期
A Randomised, Double-blind, Placebo-controlled (Within Dose Groups) Study to Evaluate Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses BIBW 2948 BS (0.75 to 150 mg Inhalation Powder, Hard Capsule for HandiHaler®) in Healthy Male Volunteers
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
- 91
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
Study to investigate safety, tolerability, and pharmacokinetics of BIBW 2948 BS
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
- 21 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males based on a complete medical history, including physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests:
- •No finding deviating from normal and of clinical relevance
- •No evidence of a clinically relevant concomitant disease
- •Aged between ≥21 and ≤50 years
- •BMI (Body Mass Index) between ≥18.5 and ≤30 kg/m2
- •Provision of written informed consent signed and dated prior to admission to the study in accordance with good clinical practice (GCP) and local legislation
排除标准
- •Any finding during the medical examination (including BP, 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 the 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 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)
- •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
研究组 & 干预措施
BIBW 2948 BS in single rising doses
Experimental
干预措施: BIBW 2948 BS for oral inhalation (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of patients with adverse events
时间窗: Up to day 29
Changes from baseline in airway resistance (Raw)
时间窗: Pre-dose, up to 24 hours after start of treatment
measured via plethysmography
Assessment of tolerability by investigator, a 4-point scale
时间窗: Up to 8 days after start of treatment
Changes from baseline in clinical laboratory tests
时间窗: Up to 8 days after start of treatment
Changes from baseline in vital signs (blood pressure, pulse rate, respiratory rate, orthostasis test, oral body temperature)
时间窗: Up to 8 days after start of treatment
Changes from baseline in 12-lead electrocardiogram (ECG)
时间窗: Up to 8 days after start of treatment
次要结局
- Maximum concentration of BIBW 3056 ZW in plasma (Cmax)(Pre-dose, up to 48 hours after start of treatment)
- Amount of BIBW 3056 ZW eliminated in urine at different time points (Aet1-t2)(Pre-dose, up to 48 hours after start of treatment)
- Area under the concentration-time curve of the analytes in plasma at different time points (AUCt1-t2)(Pre-dose, up to 48 hours after start of treatment)
- Time from dosing to maximum concentration of the analytes in plasma (tmax)(Pre-dose, up to 48 hours after start of treatment)
- Fraction of BIBW 3065 ZW eliminated in urine at different time points (fet1-t2)(Pre-dose, up to 48 hours after start of treatment)
- Renal clearance of BIBW 3056 ZW from 0 to 24 hours (CLR,0-24)(Pre-dose, up to 48 hours after start of treatment)
- Terminal rate constant of BIBW 3056 ZW in plasma (λz)(Pre-dose, up to 48 hours after start of treatment)
- Apparent volume of distribution of BIBW 3056 ZW during the terminal phase λz following an extravascular dose (Vz/F)(Pre-dose, up to 48 hours after start of treatment)
- The percentage of the AUC 0-∞ that is obtained by extrapolation (%AUCtz-∞)(Pre-dose, up to 48 hours after start of treatment)
- Terminal half life of BIBW 3056 ZW in plasma (t½)(Pre-dose, up to 48 hours after start of treatment)
- Mean residence time of BIBW 3056 ZW in the body after inhalation (MRTih)(Pre-dose, up to 48 hours after start of treatment)
- Apparent clearance of BIBW 3056 ZW in the plasma after extravascular administration (CL/F)(Pre-dose, up to 48 hours after start of treatment)
研究者
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