NCT02209714已完成1 期
A Single Increasing Dose Safety, Tolerability and Pharmacodynamics (Citric Acid Challenge) Study After Oral Administration of BIIF 1149 BS (Single Doses as Tablets: 40, 65, 100 mg) in Healthy Male Volunteers (Randomised, Double-blind Within Each Dose Group, Placebo-controlled, Parallel Groups)
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
- Number of patients with clinically relevant changes in vital functions (blood pressure, pulse rate)
研究概览
简要总结
The objective of the study is to obtain information about the safety and tolerability of BIIF 1149 BS45 (single dose: 40, 65, 100 mg), to determine the pharmacologically active dose (range) by performing a citric acid challenge test and to obtain preliminary pharmacokinetic data.
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 males, based on a complete medical examination
- •Age range from 21 to 50 years
- •+/- 20 % of their normal weight (Broca-Index)
- •Written informed consent
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 known history of orthostatic hypotension, fainting spells or blackouts
- •Volunteers with chronic or relevant acute infections (especially respiratory infections, cough)
- •Volunteers with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Volunteers who have taken a drug with a long half-life (≥ 24 hours) within ten half-lives of the respective drug before enrolment in the study
- •Volunteers who received any other drugs which might influence the results of the study during the week prior to the start of the study
- •Volunteers who have participated in another study with an investigational drug within the last 2 months preceding this study
- •Volunteers who smoke more than 10 cigarettes (or equivalent) per day
- •Volunteers who are not able to refrain from smoking on study days
- •Volunteers who drink more than 40 g of alcohol per day
- •Volunteers who are dependent on drugs
- •Volunteers who are participated in excessive physical activities (e.g. competitive sports) during the last week before the study
- •Volunteers who have donated blood (≥ 100 ml) within the last four weeks
研究组 & 干预措施
BIIF 1149 BS
Experimental
干预措施: BIIF 1149 BS (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of patients with clinically relevant changes in vital functions (blood pressure, pulse rate)
时间窗: up to 8 days after last drug administration
Number of patients with clinically relevant changes in electrocardiogram (ECG)
时间窗: up to 8 days after last drug administration
Number of patients with clinically relevant changes in laboratory parameters
时间窗: up to 8 days after last drug administration
Number of patients with adverse events
时间窗: up to 8 days after last drug administration
次要结局
- Total area under the plasma drug concentration-time curve (AUC) for several time points(up to 360 hours after drug administration)
- Mean residence time (MRT)(up to 360 hours after drug administration)
- Total clearance after oral administration (CLtot/f)(up to 360 hours after drug administration)
- Time to reach maximum drug concentration (tmax)(up to 360 hours after drug administration)
- Maximum drug plasma concentration (Cmax)(up to 360 hours after drug administration)
- Measurement of pharmacodynamic activity(Screening, at least 15 days after first administration)
- Terminal half-life (t1/2)(up to 360 hours after drug administration)
- Renal clearance in the time interval form 0 to x h (Clren0-xh)(up to 360 hours after drug administration)
- Amount of drug excreted in urine (Ae)(up to 360 hours after drug administration)
- Volume of Distribution during terminal phase after oral administration (Vz/F)(up to 360 hours after drug administration)
研究者
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