NCT02222961已完成1 期
A Single-blind, Placebo-controlled Single Increasing Dose Tolerance Study in Healthy Male Volunteers After Intravenous Administration of BIIR 561 CL as Loading Dose (Dosage: 37.5 mg/h - 150 mg/h, Infusion Time 1 Hour) Followed by Maintenance Dose (Dosage: 20 mg/h - 40 to 125 mg/h), Infusion Time 5 Hours
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Number of subjects with clinically significant findings in ECG
研究概览
简要总结
The objective of the present study is to obtain information about the safety, tolerability and pharmacokinetics of BIIR 561 after continuous intravenous administration of increasing doses in healthy young 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 volunteers
- •Age 21 to 50 years
- •Broca index from -20% to +20%
- •Written informed consent prior to admission to the study
排除标准
- •Medical examination, laboratory tests or ECG judged by the investigator to differ significantly from normal clinical values
- •Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Known diseases of the central nervous system (CNS) (such as epilepsy), CNS trauma in their medical history or with psychiatric or neurological disorders
- •Known history of orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •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 drug 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)
- •Alcohol use of more than 60 g per day
- •Drug dependency
- •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
BIIR 561 CL
Experimental
干预措施: BIIR 561 CL (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with clinically significant findings in ECG
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 significant findings in vital functions
时间窗: up to 8 days after drug administration
blood pressure, pulse rate, respiratory rate, oral body temperature
Number of subjects with clinically significant findings in laboratory tests
时间窗: up to 8 days after drug administration
次要结局
- Maximum concentration in plasma (Cmax)(up to 32 hours after first drug administration)
- Time to maximum concentration in plasma (tmax)(up to 32 hours after first drug administration)
- Terminal half-life (t1/2)(up to 32 hours after first drug administration)
- Area under the plasma concentration-time curve from zero to the last time points with a quantifiable plasma concentration (AUC0-tf)(up to 32 hours after first drug administration)
- Area under the plasma concentration-time curve extrapolated to infinity (AUC0-inf)(up to 32 hours after first drug administration)
- Total Mean residence time (MRTtot)(up to 32 hours after first drug administration)
- Total plasma clearance (CLtot)(up to 32 hours after first drug administration)
- Volume of distribution (Vz)(up to 32 hours after first drug administration)
- Volume of distribution at steady state (Vss)(up to 32 hours after first drug administration)
- Amount excreted into urine (Ae)(up to 32 hours after first drug administration)
- Mean residence time of disposition (MRTdisp)(up to 32 hours after first drug administration)
- Renal clearance (CLR)(up to 32 hours after first drug administration)
研究者
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