A Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability, Biological Effects and Preliminary Pharmacokinetics of Increasing Single Oral Doses of BIIL 284 BS (Dose Range: 0.025 mg - 75 mg PSE Solution, 25 mg, 75 mg, 250 mg and 750 mg WIF Tablets) in Healthy Male Volunteers as Well as Food Effects at 75 mg (WIF Tablet)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 95
- 主要终点
- Determination of surrogate marker cluster of differentiation antigen 11b (CD11b) (=Mac-1)
研究概览
简要总结
Study to obtain information about the safety and tolerability of BIIL 248 BS, to find the pharmacologically active dose range for the two formulations PSE 1% and WIF tablets by determination of the surrogate marker CD11b (= Mac-1) and to obtain preliminary pharmacokinetic data as well as first information on food effects after administration of the 75 mg WIF tablet in healthy male volunteers
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
- •Healthy male subjects as determined by results of screening
- •Age ≥ 21 and ≤ 50 years
- •Broca ≥ - 20% and ≤ + 20%
- •Signed written informed consent in accordance with Good Clinical Practice and local legislation
排除标准
- •Results of the medical examination or laboratory tests that are judged by the clinical investigator to differ significantly from normal clinical values
- •Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
- •Known 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 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 enrolment in the study
- •Intake of any other drugs which might influence the results of the trial during the week previous to the start of the study
- •Participation in another study with an investigational drug within the last two months preceding this study
- •Smokers (> 5 cigarettes or 2 cigars or 2 pipes/day)
- •Volunteer who is not able to refrain from smoking on study days
- •Alcohol abuse (more than 60 g of alcohol per day)
- •Drug abuse
- •Excessive physical activities (e.g. competitive sports) within the last week before the study
- •Blood donation within the last 4 weeks (≥ 100 ml)
研究组 & 干预措施
BIIL 284 BS oral solution
干预措施: BIIL 284 oral solution (Drug)
BIIL 284 BS WIF tablets
干预措施: BIIL 284 wetability improved formulation (WIF) tablets (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Determination of surrogate marker cluster of differentiation antigen 11b (CD11b) (=Mac-1)
时间窗: up to 72 hours after drug administration
Number of subjects with clinically relevant changes in vital signs
时间窗: up to 8 days after drug administration
Number of subjects with clinically relevant changes in electrocardiogram
时间窗: up to 8 days after drug administration
Number of subjects with clinically relevant changes in laboratory parameters
时间窗: up to 8 days after drug administration
Number of subjects with adverse events
时间窗: up to 8 days after drug administration
次要结局
- Terminal half-life (t1/2)(up to 72 hours after drug administration)
- Total mean residence time (MRTtot)(up to 72 hours after drug administration)
- Time to reach maximum plasma concentration (tmax)(up to 72 hours after drug administration)
- Volume of distribution during terminal phase after oral administration (Vz/f)(up to 72 hours after drug administration)
- Changes in white blood cell count(up to 48 hours after drug administration)
- Area under the plasma concentration-time curve (AUC) for several time intervals(up to 72 hours after drug administration)
- Changes in differential blood cell count(up to 48 hours after drug administration)
- Maximum plasma concentration (Cmax)(up to 72 hours after drug administration)
- Total clearance after oral administration (CLtot/f)(up to 72 hours after drug administration)