NCT02199873已完成1 期
A Single Increasing Dose Safety, Tolerability and Pharmacodynamics (Methacholine Challenge) Study After Inhalational Administration of BIIX 1 XX (Single Doses: 5 - 800 mcg) in Healthy Young Male Volunteers (Randomised, Double-blind, Placebo-controlled)
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 subjects with adverse events
研究概览
简要总结
The objective of the present study is to obtain information about the safety and tolerability of BIIX 1 XX, to determine the pharmacologically active dose (range) by performing a methacholine 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
- Single Group
- 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 male volunteers who have Broca-Indices within +-20%
- •Participants in the age range between 21 to 50 years
- •Following the methacholine challenge the airway resistance (Raw) shows an increase of at least 130%
- •In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give his written informed consent prior to admission to the study
- •As part of the screening (within 14 days before drug administration), each subject was to receive a complete medical examination (including blood pressure, pulse rate, medical history, documentation of demographics, inclusion/exclusion criteria and concomitant therapy) as well as a 12-lead Electrocardiogram (ECG)
- •Haematopoietic, hepatic and renal function test will be carried out in the laboratory
- •The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration of the test substance
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
- •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 one month before enrolment in the study
- •Use of any drugs which might influence the results of the trial 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)
- •Inability to refrain from smoking on study days
- •Alcohol abuse (> 60g/day)
- •Drug abuse
- •Blood donation within the last 4 weeks
- •Excessive physical activities within the last week before the study
研究组 & 干预措施
BIIX 1 XX - single rising dose
Experimental
干预措施: BIIX 1 XX - single rising dose (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with adverse events
时间窗: up to 3 months
Change in cutaneous microcirculation
时间窗: up to 30 minutes after drug administration
Number of subjects with abnormal changes in laboratory parameters
时间窗: up to 8 days after last drug administration
Change in impedance cardiography
时间窗: up to 30 minutes after drug administration
次要结局
- Change in specific conductance (sGaw) after methacholine challenge(up to 30 minutes after drug administration)
- Ae (Amount of analyte that is eliminated in urine)(up to 48 hours after drug administration)
- Change in airway resistance (Raw) after methacholine challenge(up to 30 minutes after drug administration)
- AUC (Area under the concentration-time curve of the analyte in plasma)(up to 168 hours after drug administration)
- Cmax (Maximum measured concentration of the analyte in plasma)(up to 168 hours after drug administration)
- MRT (Mean residence time of the analyte in the body)(up to 168 hours after drug administration)
- CL/F(Apparent clearance of the analyte in plasma following extravascular administration)(up to 168 hours after drug administration)
- tmax (Time from dosing to the maximum concentration of the analyte in plasma)(up to 168 hours after drug administration)
- t½ (Terminal half-life of the analyte in plasma)(up to 168 hours after drug administration)
研究者
相似试验
已完成
1 期
Safety, Tolerability and Pharmacodynamics of BIIF 1149 BS in Healthy Young Male VolunteersHealthyNCT02199899Boehringer Ingelheim64
已完成
1 期
Safety, Tolerability and Pharmacodynamics After Oral Administration of BIIF 1149 BS in Healthy Male VolunteersHealthyNCT02209714Boehringer Ingelheim24
终止
1 期
A Multiple Increasing Dose Safety and Tolerability Study After Inhalation Administration of BIIX 1 XX in Healthy Male VolunteersHealthyNCT02198313Boehringer Ingelheim8
已完成
1 期
Safety and Tolerability Study of BIBF 1120 as Intravenous Infusion and Absolute Bioavailability of BIBF 1120 as Soft Gelatine Capsule in Healthy SubjectsHealthyNCT02182258Boehringer Ingelheim30
已完成
1 期
Safety, Tolerance, and Pharmacokinetics of Single Oral Doses of BI 201335 NA and Bioavailability in Healthy Male SubjectsHealthyNCT02182323Boehringer Ingelheim74