NCT02209805已完成1 期
Safety and Pharmacokinetics of BIRB 796 BS Tablets Administered Twice Daily Orally (Total Daily Dose 30, 60, and 120 mg) to Healthy Human Subjects for 14 Days. A Double-blind, Placebo-controlled, Parallel Group 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
- 49
- 主要终点
- Number of patients with abnormal findings in electrocardiogram
研究概览
简要总结
Study to assess the safety and pharmacokinetics of BIRB 796 BS tablets administered as multiple daily doses at various dose levels.
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%
- •Able to communicate well with the investigator and to comply with study requirements
- •> 10 elimination half lives present since last use of any investigational drug for that investigational drug
- •Laboratory values within a clinically relevant reference range
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate, temperature, and EKG) 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 to the trial as judged by the investigator
- •History of vasculitis (past history of fever, malaise, myalgias, rash, etc.)
- •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 (< 1 months prior to administration or during trial)
- •Inability to refrain from smoking on trial days
- •Alcohol abuse (> 60 g/day)
- •Drug abuse
- •Use of methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.) < one week prior to administration of study drug
- •Blood donation or loss > 400 mL (< 1 month prior to administration or during the trial)
- •Excessive physical activities (< 5 days prior to administration or during the trial)
- •Following specific laboratory findings: total white blood cell >= 10 x 109/L, C-Reactive Protein >= 4.5 mg/L, gamma-glutamyl-transferase >= 25 U/L, aspartate transaminase >= 16 U/L, alanine transaminase >= 20 U/L any erythrocytes or > 15 mg/dl protein on urine dipstick
- •Any EKG value outside of the reference range of clinical relevance including, but not limited to QTcB > 480 ms, PR interval > 240 ms, QRS interval > 110 ms
- •History of any familial bleeding disorder
- •Inability to comply with dietary regimen of study centre
- •Inability to comply with investigator's instructions
研究组 & 干预措施
BIRB 796 BS, low dose
Experimental
干预措施: BIRB 796 BS, low dose (Drug)
BIRB 796 BS, high dose
Experimental
干预措施: BIRB 796 BS, high dose (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
BIRB 796 BS, medium dose
Experimental
干预措施: BIRB 796 BS, low dose (Drug)
BIRB 796 BS, medium dose
Experimental
干预措施: BIRB 796 BS, high dose (Drug)
结局指标
主要结局
Number of patients with abnormal findings in electrocardiogram
时间窗: up to 21 days
Number of patients with adverse events
时间窗: up to 24 days
Number of patients with clinically significant changes in vital signs
时间窗: up to 21 days
Number of patients with clinically significant changes in laboratory parameters
时间窗: up to 21 days
次要结局
- Maximum concentration of the analyte in plasma (Cmax) for several time points(up to 36 hours after dosing)
- Area under the plasma concentration versus time curve (AUC) for several time points(up to 36 hours after dosing)
- Time at which maximum plasma concentration occurred over a dosing interval (tmax)(up to 36 hours after dosing)
- Terminal elimination rate constant (λZ)(up to 36 hours after dosing)
- Elimination half-life (t1/2)(up to 36 hours after dosing)
- Mean residence time (MRT)(up to 36 hours after dosing)
- Apparent oral clearance (CL/F)(up to 36 hours after dosing)
- Apparent volume of distribution during the terminal elimination phase, divided by F (bioavailability factor) (Vz/F)(up to 36 hours after dosing)
研究者
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