NCT02254720已完成1 期
A Randomised, Single-blind, Placebo-controlled (Within Dose Groups) Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Intravenous Doses (2.5 μg, 7.5 μg, 25 μg, 50 μg, 100 μg, 200 μg, 350 μg, 500 μg Free Cation) BEA 2180 BR in Healthy Male Volunteers With an Additional Arm by Inhalation in One Dose Group (1600 μg)
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
- 71
- 主要终点
- Number of participants with abnormal findings in physical examination
研究概览
简要总结
Evaluation of safety, tolerability and pharmacokinetics of single rising intravenous doses of BEA 2180 BR; additional exploration of metabolism following inhalation
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 based upon a complete medical history, including the physical examination, regarding vital signs (BP, PR), 12 lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease.
- •Age ≥21 and ≤50 years
- •BMI ≥18.5 and <29.9 kg/m2 (Body Mass Index)
- •Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.
排除标准
- •Any finding of the medical examination (including blood pressure (BP), pulse rate (PR), and ECG measurements) deviating from normal and of clinical relevance
- •Evidence of a clinically relevant concomitant disease
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •History of relevant orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator
- •Intake of drugs with a long half-life (>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomisation
- •Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to enrolment in the study or during the study
- •Participation in another trial with an investigational drug within 2 months prior to randomisation
- •Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- •Inability to refrain from smoking on trial days as judged by the investigator
- •Alcohol abuse (regularly more than 40 g alcohol per day for men)
- •Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)
- •Excessive physical activities within 1 week prior to randomisation or during the trial
- •Any laboratory value outside the reference range that is of clinical relevance
- •Inability to comply with dietary regimen of the study centre
- •The following exclusion criteria are specific for this study due to the known class side effect profile of anticholinergic drugs:
- •hypersensitivity to tiotropium and/or related drugs of these classes
- •history of narrow-angle glaucoma
- •history of prostatic hyperplasia
- •history of bladder-neck obstruction
研究组 & 干预措施
BEA 2180 BR IV
Experimental
Rising doses
干预措施: BEA 2180 BR solution for infusion (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
BEA 2180 BR inhalation
Experimental
干预措施: BEA 2180 BR solution for inhalation (Drug)
BEA 2180 BR inhalation
Experimental
干预措施: Respimat® (Device)
结局指标
主要结局
Number of participants with abnormal findings in physical examination
时间窗: Up to day 12 after drug administration
Number of participants with clinically significant changes in vital signs
时间窗: Up to day 12 after drug administration
Number of participants with abnormal findings in 12 - lead ECG (electrocardiogram)
时间窗: Up to day 12 after drug administration
Number of participants with abnormal changes in clinical laboratory parameters
时间窗: Up to day 12 after drug administration
Number of participants with adverse events
时间窗: Up to day 12 after drug administration
Investigator assessed tolerability on a 4-point scale
时间窗: Up to day 12 after drug administration
次要结局
- t1/2 (terminal half-life of the analyte in plasma)(Up to 72 hours after drug administration)
- MRT(mean residence time of the analyte in the body)(Up to 72 hours after drug administration)
- CL (total clearance of the analyte in plasma)(Up to 72 hours after drug administration)
- Vz (apparent volume of distribution during the terminal phase λz)(Up to 72 hours after drug administration)
- Vss (apparent volume of distribution at steady state following intravascular administration)(Up to 72 hours after drug administration)
- Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)(Up to 72 hours after drug administration)
- fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)(Up to 72 hours after drug administration)
- CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)(Up to 72 hours after drug administration)
- Cmax (maximum measured concentration of the analyte in plasma)(Up to 72 hours after drug administration)
- tmax (time from dosing to maximum measured concentration)(Up to 72 hours after drug administration)
- AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(Up to 72 hours after drug administration)
- %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)(Up to 72 hours after drug administration)
- AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)(Up to 72 hours after drug administration)
- λz (terminal rate constant in plasma)(Up to 72 hours after drug administration)
研究者
相似试验
已完成
1 期
Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BEA 2180 BR in Healthy Male VolunteersHealthyNCT02254135Boehringer Ingelheim24
已完成
1 期
Study Evaluating Single Ascending Doses of AAB-001 Vaccine SAD Japanese Patients With Alzheimers DiseaseAlzheimer DiseaseNCT00397891Wyeth is now a wholly owned subsidiary of Pfizer80
已完成
1 期
Single Rising Peroral Doses of BI 1744 CL in Healthy VolunteersHealthyNCT02171793Boehringer Ingelheim24
终止
1 期
Study to Assess MEDI -578 in Patients With Osteoarthritis (OA) of the KneePainOsteoarthritisNCT01072591AstraZeneca108
已完成
1 期
Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of GMI-1359 in Healthy VolunteersHealthyNCT02931214GlycoMimetics Incorporated58