NCT02256735已完成1 期
A Double-blinded, Randomised, Placebo Controlled, Five-way Crossover Study With One Positive Control (Open-label) (Moxifloxacin) to Assess the Influence of Oral Single Dose KUC 7483 BS (40 mg, 80 mg, 160 mg, 320 mg) on the QT/QTc Interval of the ECG in Healthy Male and Female Volunteers
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
- 39
- 主要终点
- Change from baseline in mean time-matched QTcI
研究概览
简要总结
Study to investigate the effect of Ritobegron CL (KUC 7483 CL) on the QT/QTc interval of the ECG in comparison to placebo and moxifloxacin
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
- Double
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or females
- •Age 30 to 60 years
- •Body mass index (BMI) within 18.5 to 29.9 kg/m2
- •In accordance with Good Clinical Practice (GCP) and the local legislation all volunteers are to have given their written informed consent prior to admission to the study
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
- •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, moxifloxacin and/or related drugs of these classes
- •Previous tendon disease related to quinolone treatment
- •Congenital or documented acquired QT- prolongation, previous history of symptomatic arrhythmias
- •Heart rate at screening of > 80 bpm or < 45 bpm
- •Any screening ECG value outside of the reference range of clinical relevance including, but not limited to Pulse rate (PR) interval > 220 ms, QRS interval > 115 ms, QTcB > 450 ms, or QT (uncorrected) > 470 ms
- •For Female Subjects:
- •Pregnancy
- •Positive pregnancy test
- •No adequate contraception (adequate contraception e.g. sterilization, Intrauterine pessary (IUP), oral contraceptives)
- •Inability to maintain this adequate contraception during the whole study period
- •Lactation period
研究组 & 干预措施
Treatment A
Experimental
干预措施: Treatment A (Drug)
Treatment B
Experimental
干预措施: Treatment B (Drug)
Treatment C
Experimental
干预措施: Treatment C (Drug)
Treatment D
Experimental
干预措施: Treatment D (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Moxifloxacin
Active Comparator
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Change from baseline in mean time-matched QTcI
时间窗: up to 2 hours following drug administration
次要结局
- AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 8 hours) for moxifloxacin(up to 8 hours following drug administration)
- Number of subjects with adverse events(up to 17 days after last drug administration)
- Number of subjects with abnormal changes in laboratory parameters(up to 17 days after last drug administration)
- Change from baseline in mean time-matched QTcI(up to 8 hours following drug administration)
- Occurrence of uncorrected QT interval(up to 8 hours following drug administration)
- Occurrence of the QTcI interval(up to 8 hours following drug administration)
- Change from baseline of the QTcI interval(up to 8 hours following drug administration)
- Change from baseline in Heart Rate (HR)(up to 6 hours following drug administration)
- Cmax (maximum measured concentration of the analyte in plasma)(up to 8 hours following drug administration)
- tmax (time from dosing to the maximum concentration of the analyte in plasma)(up to 8 hours following drug administration)
- AUC0-6 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours)(up to 6 hours following drug administration)
- Number of subjects with abnormal changes in 12-lead ECG(up to 17 days after last drug administration)
- Number of patients with clinically significant changes in vital signs(up to 17 days after last drug administration)
- Assessment of tolerability by investigator on a 4-point scale(17 days after last drug administration)
研究者
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