NCT02203487已完成1 期
A Double-blind (Within Dose Groups), Randomised, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability and Preliminary Pharmacokinetics of Increasing Repeated Oral Doses (Nine Days Treatment of 5 mg and 10 mg and Eighteen Days Treatment of 25 mg and 40 mg) of BIIF 1149 BS 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
- 48
- 主要终点
- Number of subjects with adverse events
研究概览
简要总结
The objective of the present study was to obtain information about the safety and tolerability of BIIF 1149 BS after repeated dosing and to obtain preliminary pharmacokinetics data (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
- •Participants should be healthy males
- •Age range from 21 to 50 years
- •Within +- 20% of their normal weight (Broca-Index)
- •In accordance with Good Clinical Practice (GCP) and local legislation each volunteers are supposed to give their written informed consent prior to admission to the study
- •Each subject will have his medical history taken and will receive a complete medical examination (incl. demographics, medical history, check of inclusion/exclusion criteria, physical examination, vital signs, 12-lead Electrocardiogram (ECG)
- •Haematopoietic, hepatic and renal function test will be carried out in the laboratory
- •The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration of the test substance
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
- •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 ten half-lives of the respective drug before enrolment in the study
- •Use 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
- •Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
- •Inability to refrain from smoking on study days
- •Alcohol abuse (> 40g/day)
- •Drug abuse
- •Blood donation (>= 100 ml) within the last 4 weeks
- •Excessive physical activities (e.g. competitive sports) within the last week before the study
研究组 & 干预措施
BIIF 1149 BS - single rising dose
Experimental
干预措施: BIIF 1149 BS - single 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 55 days
Number of subjects with abnormal changes in laboratory parameters
时间窗: up to 8 days after last blood sample
Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate)
时间窗: up to 8 days after last blood sample
次要结局
- Number of subjects with clinically significant changes in 12-lead Electrocardiogram (ECG)(up to 8 days after last blood sample)
- Ae (Urinary excretion of parent drug)(up to 120 hours after last drug administration)
- Tmax (Time to maximum observed concentration of the analyte in plasma)(up to 360 hours after last drug administration)
- AUC (Area under the concentration-time curve of the analyte in plasma)(up to 360 hours after last drug administration)
- MRT (Mean residence time of the analyte in the body)(up to 360 hours after last drug administration)
- Cmax (Maximum concentration of the analyte in plasma)(up to 360 hours after last drug administration)
- Cmin,ss (Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)(after 24 hours of drug administration on day 9)
- Percent peak-trough fluctuation(up to 360 hours after last drug administration)
- RA (AUC) Accumulation factor based on AUC-data(up to 360 hours after last drug administration)
- RA (Ae) Accumulation factor based on Ae-data(up to 120 hours after last drug administration)
- RA (Cmax) Accumulation factor based on Cmax -data(up to 360 hours after drug administration on day 9)
- Cav (Average plasma concentration in a steady state interval)(24 hours after drug administration of day 9)
- t½ (Terminal half-life of the analyte in plasma)(up to 360 hours after last drug administration)
研究者
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