A Randomised, Open Label, Four-way Crossover Phase I Trial to Investigate the in Vivo Specificity of a Single Oral Dose of 320 mg KUC 7483 CL Co-administered With Bisoprolol (10 mg Daily), Propranolol (160 mg Daily), and Acipimox (500 mg Daily) Over 5 Days and a Single Inhalative Dose of 100 μg Salmeterol in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Absolute change from baseline in glucose
研究概览
简要总结
Study to compare the metabolic and electrolyte effects of a single oral dose of 320 mg ritobegron administered alone or with a pre- and comedication with bisoprolol, propranolol and acipimox. In addition, to compare the metabolic and electrolyte effects of a single dose of 320 mg ritobegron with those of a single inhalatory dose of 100 μg salmeterol
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male
- •Age >= 30 and <= 60 years
- •Body Mass Index (BMI) >= 18.5 and <= 29.9 kg/m2
- •Signed and dated written informed consent in accordance with Good Clinical Practice and local legislation
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •History of orthostatic hypotension, fainting spells or blackouts
- •Chronic or clinically relevant acute infections
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Intake of drugs with a long half-life (> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
- •Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
- •Participation in another trial with an investigational drug (within two months prior to administration or during the trial)
- •Smoker (> 10 cigarettes or > 3 cigars of > 3 pipes/day)
- •Inability to refrain from smoking on trial days
- •Alcohol abuse (> 60 g/day)
- •Drug abuse
- •Blood donation (> 100 mL within four weeks prior to administration or during the trial)
- •Any laboratory value outside the reference range if indicative of underlying disease or poor health
- •Excessive physical activities within the last week before the trial or during the trial
- •Hypersensitivity to treatment medication, salmeterol and/or related drugs of these classes
- •Congenital or documented acquired QT- prolongation, previous history of symptomatic arrhythmias
- •Systolic BP < 115 mmHg
- •Heart rate at rest of > 80 bpm or < 55 bpm
- •Any screening ECG value outside of the reference range of clinical relevance including, but not limited to PR interval > 220 ms, QRS interval > 115 ms, QTcB > 420 ms, or QT (uncorrected) > 450 ms
- •History of asthma or obstructive pulmonary disease.
- •Psoriasis (own medical history or relative)
研究组 & 干预措施
Treatment D
干预措施: Acipimox (Drug)
Treatment E
干预措施: Salmeterol (Drug)
Treatment B
干预措施: Bisoprolol (Drug)
Treatment D
干预措施: KUC 7483 CL (Drug)
Treatment A
干预措施: KUC 7483 CL (Drug)
Treatment B
干预措施: KUC 7483 CL (Drug)
Treatment C
干预措施: KUC 7483 CL (Drug)
Treatment C
干预措施: Propranolol (Drug)
结局指标
主要结局
Absolute change from baseline in glucose
时间窗: up to 24 hours after administration of study drug
Percentage change from baseline in glucose
时间窗: up to 24 hours after administration of study drug
Absolute change from baseline in free fatty acids (FFA)
时间窗: up to 24 hours after administration of study drug
Percentage change from baseline in FFA
时间窗: up to 24 hours after administration of study drug
Absolute change from baseline in insulin
时间窗: up to 24 hours after administration of study drug
Percentage change from baseline in insulin
时间窗: up to 24 hours after administration of study drug
Percentage change from baseline in Magnesium
时间窗: up to 24 hours after administration of study drug
Absolute change from baseline in cAMP
时间窗: up to 24 hours after administration of study drug
Percentage change from baseline in cAMP
时间窗: up to 24 hours after administration of study drug
Absolute change from baseline in C-Peptide
时间窗: up to 24 hours after administration of study drug
Percentage change from baseline in C-Peptide
时间窗: up to 24 hours after administration of study drug
Absolute change from baseline in Potassium
时间窗: up to 24 hours after administration of study drug
Percentage change from baseline in Potassium
时间窗: up to 24 hours after administration of study drug
Absolute change from baseline in Magnesium
时间窗: up to 24 hours after administration of study drug
次要结局
- Number of subjects with adverse events(up to 80 days)
- Number of subjects with clinically relevant changes in laboratory tests(up to 24 hours after administration of study drug)
- Number of subjects with clinically relevant changes in vital signs(up to 24 hours after administration of study drug)
- Number of subjects with clinically relevant findings in electrocardiogram(up to 24 hours after administration of study drug)
- Number of subjects with clinically relevant changes in physical examination(Baseline, within 10 days after last drug administration)
- Maximum measured concentration of the analyte in plasma(up to 24 hours after administration of study drug)
- Time from dosing to the maximum concentration of the analyte in plasma(up to 24 hours after administration of study drug)
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 4 hours(up to 24 hours after administration of study drug)