NCT02273414已完成1 期
A Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability, Biological Effects and Preliminary Pharmacokinetics of Increasing Repeated Oral Doses (9 Days Dosing) of BIIL 284 BS (Doses: 25 mg, 150 mg, 250 mg as WIF Tablets) in Healthy Male Volunteers
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
- 35
- 主要终点
- Number of subjects with adverse events
研究概览
简要总结
The objective of the present study is to obtain information about the safety and tolerability of BIIL 284 BS after repeated dosing, to find the pharmacologically active dose range by determination of the surrogate marker CD 11b (= Mac-1) and to obtain preliminary pharmacokinetic data concerning steady state and accumulation factor
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
- 21 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •All participants are healthy males
- •Age range from 21 to 50 years
- •Broca-Index: within +- 20% of their normal weight
- •In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give their written informed consent prior to admission to the study
排除标准
- •Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
- •Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
- •Volunteers with history of orthostatic hypotension, fainting spells or blackouts
- •Volunteers with chronic or relevant acute infections
- •Volunteers with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Volunteers with eosinophilia > 7 %
- •Volunteers who have taken a drug with a long half-life (>= 24 hours) within at least one month or less than ten half-lives of the respective drug before enrollment in the study
- •Volunteers who received any drugs which might influence the results of the trial the week previous to the start of the study
- •Volunteers who have participated in another study with an investigational drug within the last two months preceding this study
- •Volunteers who smoke
- •Volunteers who drink more than 60g of alcohol per day
- •Volunteers who are dependent on drugs
- •Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
- •Volunteers who have donated blood within the last 4 weeks (>= 100 mL)
研究组 & 干预措施
BIIL 284 BS - rising dose
Experimental
干预措施: BIIL 284 BS - rising dose (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with adverse events
时间窗: up to 8 days after last drug administration
Number of subjects with abnormal changes in laboratory parameters
时间窗: up to 8 days after last drug administration
Number of subjects with clinically significant changes in vital signs
时间窗: up to 8 days after last drug administration
Blood pressure, Pulse Rate, Respiratory Rate
Number of subjects with clinically significant changes in 12-lead electrocardiogram
时间窗: up to 8 days after last drug administration
次要结局
- tmax (Time from dosing to the maximum concentration of the analyte in plasma)(up to 80 hours after drug administration)
- Cmax (Maximum measured concentration of the analyte in plasma)(up to 80 hours after drug administration)
- Changes in Leucotriene B4 (LTB4) induced Mac-1 expression(up to 24 hours after last treatment on day 9)
- AUC0-24h (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours)(up to 24 hours after drug administration)
- t½ (Terminal half-life of the analyte in plasma)(up to 80 hours after drug administration)
- MRTtot (Total mean residence time)(up to 80 hours after drug administration)
- Vz/F (Apparent volume of distribution of the analyte during the terminal phase)(up to 80 hours after drug administration)
- CLtot/F (Total clearance after oral administration)(up to 80 hours after drug administration)
- Ae0-24h (Amount of analyte that is eliminated in urine from 0 to 24 hours)(up to 24 hours after drug administration)
- AUCss (Area under the plasma concentration-time curve at steady state)(up to 80 hours after drug administration)
- Cpre,ss (Predose concentration of the analyte in plasma at steady state)(up to 80 hours after drug administration)
研究者
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