NCT02268136终止1 期
A Single-blind, Placebo-controlled, Parallel Group, Single Increasing Dose Tolerance Study in Healthy Male Volunteers After Intravenous Administration of BIII 890 CL (Dosage: 0.5 mg/h - 80 mg/h), Infusion Time 1 Hour.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 76
- 主要终点
- Number of subjects with clinically relevant changes in vital signs
研究概览
简要总结
The objective ot the present study is to obtain information about safety, tolerability and preliminary pharmacokinetics of BIII 890 CL after single intravenous administration of increasing doses 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
- Single
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 index ≥ - 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, laboratory tests or electrocardiogram recordings are judged by the clinical investigator to differ significantly from normal clinical values
- •Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Volunteers with diseases of the central nervous system (such as epilepsy), central nervous system trauma in the medical history or with psychiatric disorders or neurological 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 the last 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 (> 10 cigarettes or 3 cigars or 3 pipes/day)
- •Volunteers who are not able to refrain from smoking on study days
- •Alcohol abuse (more than 60 g/day)
- •Drug abuse
- •Participation in excessive physical activities (e.g. competitive sports) within the last week before the study
- •Blood donation (≥ 100 ml) within the last 4 weeks
研究组 & 干预措施
BIII 890 CL
Experimental
single increasing doses
干预措施: BIII 890 CL (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with clinically relevant changes in vital signs
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
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 pharmaco electroencephalogram (EEG)
时间窗: up to 24 hours after drug administration
Number of subjects with clinically relevant changes in laboratory parameters
时间窗: up to 8 days after drug administration
次要结局
- Plasma clearance (CL)(up to 24 hours after drug administration)
- Volume of distribution (Vz)(up to 24 hours after drug administration)
- Amount of the analyte excreted in urine (Ae)(up to 24 hours after drug administration)
- Time to reach Cmax (tmax)(up to 24 hours after drug administration)
- Terminal half-life (t1/2)(up to 24 hours after drug administration)
- Area under the plasma concentration-time curve (AUC) for several time points(up to 24 hours after drug administration)
- Mean residence time (MRT)(up to 24 hours after drug administration)
- Maximum plasma concentration (Cmax)(up to 24 hours after drug administration)
研究者
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