NCT02211157已完成1 期
Safety, Pharmacokinetics and Pharmacodynamics of BIRB 796 BS Tablets (20, 30, 150, 300, and 600 mg) Administered Orally to Healthy Human Subjects Once Daily for 7 Days. A Placebo Controlled, Randomised, Double Blinded Study
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
- 24
- 主要终点
- Number of patients with clinically relevant changes in vital signs
研究概览
简要总结
Study to assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating multiple doses with and without a 64 g fat breakfast at the 50 mg dose level
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects as determined by results of screening
- •Signed written informed consent in accordance with Good Clinical Practice and local legislation
- •Age ≥ 18 and ≤ 45 years
- •Broca ≥ - 20% and ≤ + 20%
排除标准
- •Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
- •Surgery of gastrointestinal tract (except appendectomy)
- •History of orthostatic hypotension, fainting spells and blackouts
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •Chronic or relevant acute infections
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Intake of drugs with a long half-life (>24 hours) within 1 month prior to administration or during the trial)
- •Use of any drugs which might influence the results of the trial within 10 days prior to administration or during trial
- •Participation in another trial with an investigational drug within 2 months prior to administration or during trial
- •Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
- •Inability to refrain from smoking on study days
- •Alcohol abuse (> 60 g/day)
- •Drug abuse
- •Blood donation > 400 ml within 1 month prior to administration or during the trial
- •Excessive physical activities within 5 days prior to administration or during the trial
- •Any laboratory value outside the reference range of clinical relevance including, but not limited to total white cell count ≥ 10 x 10**9/L, C-reactive protein ≥ 4.5 mg/L, Gamma-Glutamyl Transferase ≥ 40 U/L, any hemoglobin or > 15 mg/dl protein or urine dipstick, abnormal Multitest® assessment of cellular immunity
- •History of any familial bleeding disorder
- •Inability to comply with dietary regimen of study centre
研究组 & 干预措施
BIBR 796 BS, fasted
Experimental
dose escalation
干预措施: BIBR 796 BS (Drug)
BIBR 796 BS, fed
Experimental
50 mg BIRB 796 BS (food effect)
干预措施: BIBR 796 BS (Drug)
BIBR 796 BS, fed
Experimental
50 mg BIRB 796 BS (food effect)
干预措施: high fat breakfast (Other)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of patients with clinically relevant changes in vital signs
时间窗: up to 16 days
Number of patients with clinically relevant changes in laboratory parameters
时间窗: up to day 16
Number of patients with abnormal findings in electrocardiogram (ECG)
时间窗: up to day 16
Number of patients with adverse events
时间窗: up to 30 days
Assessment of tolerability on a 4-point scale
时间窗: day 16
次要结局
- Maximum plasma concentration (Cmax) for several time points(up to day 9)
- Area under the plasma concentration-time curve (AUC) for several time points(up to day 9)
- Time to maximum concentration (tmax)(up to day 9)
- Elimination rate constant (λz)(up to day 9)
- Terminal half-life (t1/2)(up to day 9)
- Mean residence time (MRT)(up to day 9)
- Apparent clearance (CL/f)(up to day 9)
- Apparent volume of distribution (Vz/F)(up to day 9)
- Assessment of neutrophil and monocyte activation by ex vivo stimulation of whole blood with formyl-methionyl-leucyl-phenylalanine (fMLP)(up to day 9)
- Assessment of neutrophil and monocyte activation by ex vivo stimulation of whole blood with tumour necrosis factor (TNF) α(up to day 9)
- Assessment of TNFα production by ex vivo stimulation of whole blood with endotoxin(up to day 9)
- Changes in cellular immune response measured by Multitest®(Day 8)
研究者
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