NCT02211170已完成1 期
The Effect of Single Oral Dose BIRB 796 BS (50 and 600 mg) on Endotoxin-induced Inflammatory Responses in Healthy Human Subjects. A Placebo-controlled, Randomised, Parallel, 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
- Reduction of tumour necrosis factor alpha (TNFα) concentration
研究概览
简要总结
Study to determine the effect of a single dose BIRB 796 BS on systemic inflammatory responses induced by endotoxin in healthy humans
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 35 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 ≤ 35 years
- •Broca ≥- 20 % and ≤ + 20%
- •Able to communicate well with the investigator and to comply with study requirements
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate 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 within 14 days of enrolment
- •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 administration or during the trial)
- •Participation in another trial with an investigational drug (< 3 months prior to administration or 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 (< 2 month prior to administration or during the trial)
- •Excessive physical activities (< 24 hours prior to administration or during the trial)
- •Any laboratory value outside the reference range of clinical relevance
- •History of any familial bleeding disorder
- •Weight > 150 kg
- •Prior confirmed or suspected receipt of a monoclonal antibody
研究组 & 干预措施
BIBR 796 BS, high dose
Experimental
干预措施: Lipopolysaccharide (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
干预措施: Lipopolysaccharide (Drug)
BIBR 796 BS, low dose
Experimental
干预措施: BIBR 796 BS, low dose (Drug)
BIBR 796 BS, low dose
Experimental
干预措施: Lipopolysaccharide (Drug)
BIBR 796 BS, high dose
Experimental
干预措施: BIBR 796 BS, high dose (Drug)
结局指标
主要结局
Reduction of tumour necrosis factor alpha (TNFα) concentration
时间窗: up to 2 days
次要结局
- Apparent clearance (CL/F)(up to 27 hours after drug administration)
- Reduction of anti-inflammatory cytokine and cytokine inhibitors (IL-10, IL-12p40, soluble TNF receptor (sTNFr) type 1, IL-1ra)(up to 2 days)
- Reduction of ex vivo p38 mitogen-activated protein kinase (MAPK) phosphorylation activity(up to 2 days)
- Number of patients with abnormal changes in laboratory parameters(up to 14 days)
- Reduction of pro-inflammatory cytokines (IL-6, IL-8, G-CSF)(up to 2 days)
- Reduction of Acute Phase Proteins (C-reactive protein, Haptoglobin)(up to 2 days)
- Reduction of Endothelial Activation Markers (von Willebrand Factor, soluble E-selectin)(up to 2 days)
- Reduction of Granulocyte Responses (white blood cell (WBC) count with differential, elastase, elastase-á1-antitrypsin complexes)(up to 2 days)
- Number of patients with clinically significant changes in vital signs (pulse rate, systolic and diastolic blood pressure, temperature)(up to 14 days)
- Reduction of flow Cytometry Cell Surface Markers (Mac-1 (macrophage-1 antigen), L-Selectin)(up to 2 days)
- Occurence and severity of with chills, nausea, vomiting, abdominal pain, backache, headache, myalgia, fever(up to 2 days)
- Number of patients with adverse events(up to 14 days)
- Maximum plasma concentration (Cmax)(up to 27 hours after drug administration)
- Area under the plasma concentration-time curve for different time points(AUC)(up to 27 hours after drug administration)
- Assessment of Global Clinical Tolerability on a 4-point scale(after 14 days)
- Time at which Cmax occurred (tmax)(up to 27 hours after drug administration)
- Elimination half life (t1/2),(up to 27 hours after drug administration)
- Mean residence time (MRT)(up to 27 hours after drug administration)
- Apparent volume of distribution (Vz/F)(up to 27 hours after drug administration)
- Elimination rate constant (λz)(up to 27 hours after drug administration)
研究者
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