Effect of Cytochrome P 450 3A4 Inhibition by Itraconazole on the Single Oral Dose Pharmacokinetics of Cilobradine
2014年10月13日 更新者:Boehringer Ingelheim
The Effect of Cytochrome P 450 3A4 Inhibition by Itraconazole on the Single Oral Dose Pharmacokinetics of Cilobradine (an Open-label, Randomised, Single-dose, Two-way Crossover Study)
Study to investigate the effect of cytochrome P 450 3A4 inhibition by itraconazole on the single dose pharmacokinetics of cilobradine
研究概览
研究类型
介入性
注册 (实际的)
25
阶段
- 阶段1
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 至 55年 (成人)
接受健康志愿者
是的
有资格学习的性别
男性
描述
Inclusion Criteria:
Healthy males according to the following criteria:
Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead 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 pulse rate (PR; after 10 min. in the supine position) of more than 55 bpm
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Exclusion Criteria:
- 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 (more than 60 g/day)
- Drug 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Cilobradine, low dose plus itraconazole
Pre-study
|
其他名称:
|
有源比较器:Cilobradine, low dose
Pre-study
|
|
实验性的:Cilobradine, high dose plus itraconazole
main study
|
其他名称:
|
有源比较器:Cilobradine, high dose
main study
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
大体时间:up to 56 hours after administration of Cilobradine
|
up to 56 hours after administration of Cilobradine
|
Maximum measured concentration of the analyte in plasma (Cmax)
大体时间:up to 56 hours after administration of Cilobradine
|
up to 56 hours after administration of Cilobradine
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
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 (AUC0-tz)
大体时间:up to 56 hours after administration of Cilobradine
|
up to 56 hours after administration of Cilobradine
|
|
Time from dosing to Cmax (Tmax)
大体时间:up to 56 hours after administration of Cilobradine
|
up to 56 hours after administration of Cilobradine
|
|
Terminal rate constant in plasma (λz)
大体时间:up to 56 hours after administration of Cilobradine
|
up to 56 hours after administration of Cilobradine
|
|
Terminal half-life of the analyte in plasma (t1/2)
大体时间:up to 56 hours after administration of Cilobradine
|
up to 56 hours after administration of Cilobradine
|
|
Mean residence time of the analyte in the body after p.o. administration (MRTpo)
大体时间:up to 56 hours after administration of Cilobradine
|
up to 56 hours after administration of Cilobradine
|
|
Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)
大体时间:up to 56 hours after administration of Cilobradine
|
up to 56 hours after administration of Cilobradine
|
|
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
大体时间:up to 56 hours after administration of Cilobradine
|
up to 56 hours after administration of Cilobradine
|
|
Amount of parent compound excreted in urine with zero to 72 h in % of dose (fe0-tz)
大体时间:up to 72 hours after administration of Cilobradine
|
up to 72 hours after administration of Cilobradine
|
|
Renal clearance of cilobradine (CLR,0-tz)
大体时间:up to 72 hours after administration of Cilobradine
|
up to 72 hours after administration of Cilobradine
|
|
Number of subjects with adverse events
大体时间:up to 46 days
|
up to 46 days
|
|
Occurrence of visual phenomena
大体时间:up to 46 days
|
questionnaire
|
up to 46 days
|
Number of subjects with clinically relevant findings in vital signs
大体时间:up to 32 days
|
blood pressure, pulse rate
|
up to 32 days
|
Number of subjects with clinically relevant findings in laboratory tests
大体时间:up to 32 days
|
up to 32 days
|
|
Number of subjects with clinically relevant findings in 12-lead electrocardiogram
大体时间:up to 32 days
|
up to 32 days
|
|
Assessment of tolerability by investigator on a 4-point scale
大体时间:within 8 days after last PK sampling
|
within 8 days after last PK sampling
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2004年1月1日
初级完成 (实际的)
2004年4月1日
研究注册日期
首次提交
2014年10月13日
首先提交符合 QC 标准的
2014年10月13日
首次发布 (估计)
2014年10月15日
研究记录更新
最后更新发布 (估计)
2014年10月15日
上次提交的符合 QC 标准的更新
2014年10月13日
最后验证
2014年10月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 503.213
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