NCT02264015已完成1 期
Pharmacodynamic Effects, Safety and Tolerability of 2 mg and 5 mg Cilobradine, Administered p.o. Once Daily Over 14 Days to Healthy Male and Female Volunteers in a Randomised, Placebo-controlled, Double Blind Study, With an Open-label Uncontrolled Intra-individual Comparison to 400 mg Moxifloxacin Single Dose in a Subset of 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
- 125
- 主要终点
- Change in heart rate at rest
研究概览
简要总结
Incidence of visual phenomena, heart rate at rest, safety (with particular emphasis on QT analysis of ECGs), and pharmacokinetic parameters
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
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females according to the following criteria:
- •Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
- •1.1 No finding deviating from normal and of clinical relevance
- •1.2 No evidence of a clinically relevant concomitant disease
- •Age ≥21 and Age ≤55 years
- •BMI ≥18.5 and BMI < 30 kg/m2 (Body Mass Index)
- •Resting Heart rate (HR) (after 10 min. in the supine position) of equal or more than 60 bpm
- •Females: post-menopausal or those who have had a hysterectomy (plus a negative pregnancy test)
- •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
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, ophthalmological, 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 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 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- •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 administration or during the trial
- •Participation in another trial with an investigational drug within two months prior to administration or during the trial
- •Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
- •Inability to refrain from smoking on trial days
- •Alcohol abuse
- •Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- •Excessive physical activities (within one week prior to administration or during the trial)
- •Any laboratory value outside the reference range that is of clinical relevance.
- •Exclusion criteria specific for this study:
- •Subjects at increased risk for development of cardiac arrhythmia (e.g. family history of long QT syndrome or sudden cardiac death)
研究组 & 干预措施
Cilobradine low
Experimental
干预措施: Cilobradine, low, film-coated tablets (Drug)
Placebo
Placebo Comparator
干预措施: Placebo, film-coated tablets (Drug)
Moxifloxacin
Active Comparator
干预措施: Moxifloxacin, film-coated tablets (Drug)
Cilobradine high
Experimental
干预措施: Cilobradine, high, film-coated tablets (Drug)
结局指标
主要结局
Change in heart rate at rest
时间窗: Pre dose, up to 12 hours after drug administration
Incidence of visual phenomena
时间窗: Up to 12 days after last scheduled study day
Reported as adverse events
次要结局
- Investigator assessed tolerability on a 4 point scale(Up to 12 days after last scheduled study day)
- Characteristics of visual phenomena on a special questionnaire(Up to 12 days after last scheduled study day)
- Number of participants with abnormal changes in clinical laboratory parameters(Up to 12 days after last scheduled study day)
- Maximum plasma concentration following the first dose (Cmax)(Up to 24 hours after drug administration)
- Area under the concentration-time curve of the analyte in plasma from zero time to 24 hours (AUC0-24)(Up to 24 hours after drug administration)
- Mean residence time of the analyte in the body after oral administration (MRTpo)(Up to 24 hours after drug administration)
- Number of participants with abnormal findings in physical examination(Up to 12 days after last scheduled study day)
- Number of participants with adverse events(Up to 12 days after last scheduled study day)
- Number of participants with abnormal findings in electrocardiogram (ECG)(Up to 12 days after last scheduled study day)
- Terminal half-life (t1/2)(Up to 24 hours after drug administration)
- Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F)(Up to 24 hours after drug administration)
- Number of participants with clinically significant changes in vital signs(Up to 12 days after last scheduled study day)
- Time from first dose to the maximum plasma concentration (tmax)(Up to 24 hours after drug administration)
- Apparent clearance of the analyte in plasma following extravascular administration (CL/F)(Up to 24 hours after drug administration)
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