NCT02184338已完成1 期
Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BIRB 1017 BS (5, 25, 100, 250, 500, and 800 mg) as a Solution in PEG 400 / 26% Ethanol Administered to Healthy Male Subjects. Placebo Controlled and Blinded at Each Dose Level
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Number of patients with abnormal changes in clinical laboratory tests
研究概览
简要总结
Study to assess safety, tolerability and pharmacokinetics of BIRB 1017 BS in single rising oral doses of 5 to 800 mg in a polyethylene glycol 400 (PEG 400) / 26% ethanol solution in healthy male subjects
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 50 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 <= 50 years
- •BMI >18.5 and <29.9 kg/m2 (Body Mass Index)
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, haematological, oncological or hormonal disorders
- •Surgery of gastrointestinal tract (except appendectomy)
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •Relevant 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
- •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 study drug administration or expected during the trial)
- •Participation in another trial with an investigational drug (< 2 months prior to administration or expected during trial)
- •Smoker (> 10 cigarettes or >3 cigars or >3 pipes/day)
- •Inability to refrain from smoking on trial days
- •Alcohol abuse (> 60 g/day)
- •Drug abuse
- •Blood donation or loss > 400 mL, < 1 month prior to administration or expected during the trial
- •Excessive physical activities (within 5 days prior to administration or during the trial)
- •Clinically relevant laboratory abnormalities
- •Any electrocardiogram value outside of the reference range and of clinical relevance including, but not limited to QRS interval > 110 ms or QTcB > 450 ms or QT >500 ms
- •Known hypersensitivity to the drug or its excipients
- •Inability to comply with dietary regimen of study centre
- •Inability to comply with investigator's instructions
研究组 & 干预措施
BIRB 1017 BS in single rising doses
Experimental
干预措施: BIBR 1017 BS powder (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of patients with abnormal changes in clinical laboratory tests
时间窗: up to day 10
Number of patients with clinically relevant effect on electrocardiogram parameters
时间窗: up to day 10
Number of patients with adverse events
时间窗: up to 25 days
Number of patients with clinically significant changes in vital signs (pulse rate, systolic and diastolic blood pressure)
时间窗: up to day 10
Assessment of safety and tolerability by the investigator on a 4-point scale
时间窗: at day 5-10
次要结局
- Time from dosing to maximum concentration (tmax)(pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 15:00, 24:00, 34:00, and 48:00 hours after administration of study drug)
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable analyte plasma concentration (AUC0-tz)(pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 15:00, 24:00, 34:00, and 48:00 hours after administration of study drug)
- Terminal half-life of the analyte in plasma (t1/2)(pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 15:00, 24:00, 34:00, and 48:00 hours after administration of study drug)
- Mean residence time of the analyte in the body (MRT)(pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 15:00, 24:00, 34:00, and 48:00 hours after administration of study drug)
- Apparent oral clearance of the analyte in the plasma after oral administration (CL/F)(pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 15:00, 24:00, 34:00, and 48:00 hours after administration of study drug)
- Maximum concentration of BIRB 1017 BS in plasma (Cmax)(pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 15:00, 24:00, 34:00, and 48:00 hours after administration of study drug)
- Terminal elimination rate constant in plasma (λz)(pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 15:00, 24:00, 34:00, and 48:00 hours after administration of study drug)
- Area under the concentration-time curve of the analyte in plasma ofer the time interval from 0 to the last quantifiable analyte plasma concentration (AUC0-infinity)(pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 15:00, 24:00, 34:00, and 48:00 hours after administration of study drug)
- Apparent volume of distribution during the terminal phase λz following an oral dose (Vz/F)(pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 15:00, 24:00, 34:00, and 48:00 hours after administration of study drug)
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