NCT02269215已完成1 期
A Single Blind, Placebo-controlled, Parallel-group, Single Increasing Dose Tolerance Study in Healthy Young Male Volunteers After Intravenous Administration of BIII 890 CL as Loading Dose (Dosage: 12.5, 25, 50 mg/h, Infusion Time 1 hr; 50 mg/h, Infusion Time 2 Hrs) Followed by Maintenance Dose (Dosage: 6.25, 12.5, 25 mg/h, Infusion Time 5 Hrs; 30 mg/h, Infusion Time 4 Hrs) and in Healthy Elderly Male and Female Volunteers After Intravenous Administration of BIII 890 CL as Loading Dose (Dosage: 50 mg/h, Infusion Time 1 hr) Followed by Maintenance Dose (Dosage: 25 mg/h, Infusion Time 5 Hrs)
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
- 73
- 主要终点
- Number of patients with clinically relevant changes in vital signs
研究概览
简要总结
Safety, tolerability and pharmacokinetics of BIII 890
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants in the study should be healthy males, range from 21 to 50 years of age and be within +- 20% of their normal weight (Broca-Index) and healthy elderly males and females, > 60 years of age and be within +-25 % of their normal weight (Broca-Index)
- •In accordance with good clinical practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study
排除标准
- •Volunteers were excluded from the study if the results of the medical examination, laboratory tests or ECG recordings are judged by the 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), central nervous system (CNS) trauma in their medical history or with psychiatric disorders or neurological disorders
- •Volunteers with known history of relevant orthostatic hypotension, fainting spells or blackouts
- •Volunteers with chronic or relevant acute infections
- •Volunteers with history of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as, judged by the investigator
- •Volunteers who had taken 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
- •Volunteers who received any other drugs which could influence the results of the trial during the week prior to the start of the study
- •Volunteers who participated in another study with an investigational drug within the last two months preceding this study
- •Volunteers who smoke (> 10 cigarettes or 3 cigars or 3 pipes/day)
- •Volunteers who were not able to refrain from smoking on study days
- •Volunteers who drunk more than 60 g of alcohol per day
- •Volunteers who were dependent on drugs
- •Volunteers who participated in excessive physical activities (e.g. competitive sports) during the last week before the study
- •Volunteers who donated blood within the last 4 weeks (≥ 100 mL)
研究组 & 干预措施
BIII 890 CL single rising dose
Experimental
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 patients with clinically relevant changes in vital signs
时间窗: Pre-dose, up to 8 days after drug administration
blood pressure, pulse rate, respiratory rate, body temperature
Number of subjects with clinically relevant changes in laboratory parameters
时间窗: Pre-dose, up to 8 days after drug administration
including coagulation parameters
Number of subjects with adverse events
时间窗: Up to 8 days after drug administration
Number of subjects with clinically relevant changes in 12-lead ECG
时间窗: Pre-dose, up to 8 days after drug administration
次要结局
- Maximum measured concentration of the analyte in plasma (Cmax)(up to 32 hours after start of drug administration)
- Apparent terminal half-life of the analyte in plasma (t1/2)(up to 32 hours after start of drug administration)
- Volume of distribution (V)(up to 32 hours after start of drug administration)
- Mean residence time (MRT)(up to 32 hours after start of drug administration)
- Time from dosing to the maximum concentration of the analyte in plasma over a uniform dosing interval λz (tmax)(up to 32 hours after start of drug administration)
- Area under the concentration-time curve of the analyte in plasma (AUC)(up to 32 hours after start of drug administration)
- Plasma clearance (CL)(up to 32 hours after start of drug administration)
- Amount of parent drug excreted into urine (Ae)(up to 32 hours after start of drug administration)
研究者
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