NCT02208856已完成1 期
Safety, Pharmacokinetics and Pharmacodynamics of Single Rising Doses (1, 4, 15, 50, 100, 200, 400, and 600 mg) Oral BIRB 796 BS in Healthy Human Subjects. A Placebo Controlled, Randomised Study, Double Blinded at Each Dose Level
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
- 64
- 主要终点
- Number of subjects with clinically relevant changes in electrocardiograms (ECG)
研究概览
简要总结
To assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating single doses, with and without a 64 g fat breakfast at one selected dose.
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 (GCP) and local legislation
- •Age >= 18 and <= 45 years
- •Broca >= -20% and <= +20%
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Surgery of gastrointestinal tract (except appendectomy)
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •History of orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant ot the trial as judged by the investigator
- •Intake of drugs with a long half-life (> 24 hours) (= 1 month prior to administration or during the trial)
- •Use of any drugs, which might influence the results of the trial (= 10 days prior to administration or during the trial)
- •Participation in another trial with an investigational drug (=2 months prior to administration or during trial)
- •Smoker (> 10 cigarettes of > 3 cigars of > 3 pipes/day)
- •Inability to refrain from smoking on trial days
- •Alcohol abuse (> 60 g/day)
- •Drug abuse
- •Blood donation > 400 ml (=1 month prior to administration of during the trial)
- •Excessive physical activities (= 5 days prior to administration or during the trial)
- •Any laboratory value outside the reference range of clinical relevance (but not exclusive to) total white cell count >= 10 x 10**9/L, C-reactive protein >= 4.5 mg/L, any haemoglobin or > 15 mg/dl protein on urine dipstick
- •History of any familial bleeding disorder
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
BIBR 796 BS food effect
Experimental
干预措施: BIBR 796 BS (Drug)
BIBR 796 BS food effect
Experimental
干预措施: high fat standardized breakfast (Other)
BIBR 796 BS
Experimental
干预措施: BIBR 796 BS (Drug)
结局指标
主要结局
Number of subjects with clinically relevant changes in electrocardiograms (ECG)
时间窗: Baseline, up to 96 hours after drug administration
Number of subjects with adverse events
时间窗: up to 96 hours after drug administration
Number of subjects with clinically relevant changes in vital signs
时间窗: Baseline, up to 96 hours after drug administration
Number of subjects with clinically relevant changes in laboratory measurements
时间窗: Baseline, up to 96 hours after drug administration
次要结局
- Maximum concentration of the analyte in plasma (Cmax)(up to 48 hours after drug administration)
- Area under the concentration-time curve of the analyte in plasma from time zero to infinity (AUC0-inf)(up to 48 hours after drug administration)
- Time from dosing to the maximum concentration of the analyte in plasma (Tmax)(up to 48 hours after drug administration)
- Terminal rate constant of the analyte in plasma (λz)(up to 48 hours after drug administration)
- Half life of the analyte in plasma (t1/2)(up to 48 hours after drug administration)
- Mean residence time of the analyte in the body (MRTtot)(up to 48 hours after drug administration)
- Mac-1/L selectin ratio of TNFalpha-stimulated to unstimulated neutrophils(up to 48 hours after drug administration)
- Apparent clearance of the analyte in plasma (CL/F)(up to 96 hours after drug administration)
- Apparent volume of distribution during the terminal phase λz (Vz/F)(up to 48 hours after drug administration)
- Mac-1/L selectin ratio of formyl-methionyl-leucyl-phenylalanine (fMLP)-stimulated to unstimulated neutrophils(up to 48 hours after drug administration)
- Percent changes in TNFalpha production(up to 48 hours after drug administration)
研究者
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