To Compare Blood and Urine Concentrations of Mirabegron (YM178) in Healthy Poor or Extensive Metabolizers for CYP2D6 and to Assess the Effect of Mirabegron on the Metabolism of Metoprolol
An Open Label, One-sequence, Parallel Study to Compare the Single Dose Pharmacokinetics of YM178 in Healthy Poor or Extensive Metabolisers for CYP2D6 and to Assess the Effect of Multiple Doses of YM178 on the Metabolism of the Model Substrate Metoprolol
研究概览
详细说明
The study is an open label, single center study. All subjects are genotyped for CYP2D6 before the study. Genotype expression is confirmed by dextromethorphan phenotyping.
Part I: The pharmacokinetic profile of a single dose of YM178 is compared in 8 healthy male subjects genotyped and phenotyped as poor metaboliser (PM) for CYP2D6 and in 8 healthy male subjects genotyped and phenotyped as extensive metaboliser (EM) for CYP2D6.
Part II: The effect of YM178 on the model substrate of CYP2D6 metoprolol is evaluated, using a cross-over design, in 12 healthy male subjects genotyped and phenotyped as EM for CYP2D6.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
-
Zuidlaren、荷兰、9471 GP
- PRA International (former Pharma Bio-Research)
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
For Part I:
- Subject genotyped and phenotyped for CYP2D6
- Body weight between 60 and 100 kg and Body Mass Index less than or equal to 30 kg/m2
For Part II:
- Subject genotyped and phenotyped as extensive metaboliser for CYP2D6
- Body weight between 60 and 100 kg and Body Mass Index less than or equal to 30 kg/m2
Exclusion Criteria:
- Known or suspected hypersensitivity to β-adrenergic receptor agonists or constituents of the formulations used
- Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug
- Any clinically significant history of upper gastrointestinal symptoms (such as nausea, vomiting, abdominal discomfort or upset, or heartburn) in the 4 weeks prior to admission to the Research Unit
- Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic
- Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests
- QTc intervals of >430 msec
- Abnormal pulse rate measurement (<40 or >90 bpm) taken by manual counting at the pre-study visit after subject has been resting in supine position for 5 min
- Abnormal blood pressure measurements taken at the pre-study visit after subject has been resting in supine position for 5 min as follows: systolic blood pressure <95 or >160 mmHg; diastolic blood pressure <40 or >95 mmHg
- Positive orthostatic test at screening i.e. any symptoms of dizziness, light-headedness etc. and/or a fall of ≥ 20 mmHg in systolic blood pressure after 2 min standing (preceded by 5 min. supine rest) and/or an increase in pulse rate of ≥ 20 bpm
- Regular use of any prescribed or OTC drugs except paracetamol up to 3 g/day, in the 4 weeks prior to admission to the Research Unit OR any use of such drugs in the 2 weeks prior to admission to the Research Unit
学习计划
研究是如何设计的?
设计细节
- 分配:非随机化
- 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:Treatment Arm 1A
mirabegron, poor metabolizers
|
口服
其他名称:
|
实验性的:Treatment Arm 1B
mirabegron, extensive metabolizers
|
口服
其他名称:
|
实验性的:Treatment Arm 2
mirabegron/metoprolol
|
口服
其他名称:
oral
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Pharmacokinetics of mirabegron assessed by plasma concentration
大体时间:Pre-dose until 72 hours after dosing
|
Primary outcome measure for Part 1
|
Pre-dose until 72 hours after dosing
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Pharmacokinetics of metoprolol assessed by plasma concentration
大体时间:Pre-dose until 48 hours after dosing
|
Primary outcome measure for Part 2
|
Pre-dose until 48 hours after dosing
|
合作者和调查者
调查人员
- 首席研究员:Principal Investigator、Pharma Bio-Research Group B.V., Zuidlaren, The Netherlands
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
米拉贝隆的临床试验
-
Genuine Research Center, EgyptHikma Pharma完全的
-
Aaron CypessNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes...完全的
-
Chang Gung Memorial Hospital完全的
-
Women and Infants Hospital of Rhode IslandPatient-Centered Outcomes Research Institute; University of California, San Diego; University... 和其他合作者招聘中