A Study to Evaluate Cardiovascular Interactions Between Mirabegron and Tamsulosin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Cardiovascular interactions assessed by blood pressure and pulse rate
研究概览
简要总结
The study aims to compare blood pressure and pulse in male healthy subjects taking mirabegron and tamsulosin both alone and in combination.
详细描述
Treatment arm 1 (effect of mirabegron on tamsulosin): Subjects are randomized into one of two sequences.
Subjects receive 2 singles doses of tamsulosin, once in the absence of mirabegron and once in the presence of mirabegron.
24-hour Cardiovascular (CV) profiles are taken at both baseline days and after the single dose of tamsulosin /combination dose in each sequence. Regular blood samples are also taken to check for a potential Pharmacokinetic (PK) interaction.
Treatment arm 2 (effect of tamsulosin on mirabegron): Subjects are randomized into one of two sequences.
Subjects receive 2 singles doses of mirabegron, once in the absence of tamsulosin and once in the presence of tamsulosin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2
排除标准
- •Known or suspected hypersensitivity to mirabegron and/or tamsulosin HCl, or any components of the formulations used
- •Any of the liver function tests (i.e. Alanine Aminotransferase (ALT) and Asparate Aminotransferase (AST) above the upper limit of normal at repeated measures (at least one more time)
- •Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever)
- •Any prior clinically significant psychiatric history including hospitalization for mental health management
- •Subject is at risk of urinary retention based on medical history
- •Any clinically significant abnormality following the investigator's review of the pre-study physical examination, Electrocardiogram (ECG) and clinical laboratory tests
- •Heart rate and/or blood pressure measurements at the screening and admission visits as follows: Heart rate <50 or >90 bpm; mean systolic blood pressure <90 mm Hg or >140 mmHg (>160 mmHg for subjects 65 years or older); mean diastolic blood pressure <60 mm Hg or >90 mmHg (>100 mmHg for subjects 65 years or older) (blood pressure measurements to be taken after subject has been resting in supine position for 5 min; heart rate will be measured automatically; both to be taken in triplicate)
- •A QTc interval of > 430 ms after repeated measurements (at least two more times), a history of syncope, orthostatic hypotension, vertigo, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)
- •A hemoglobin value <12.5 g/dl (7.8 mmol/l) and/or a hematocrit value <37.9% and/or a Red Blood Cell count <4.08 T/l (4080 mm3)
研究组 & 干预措施
Treatment Arm 1
tamsulosin singles doses; mirabegron multiple dose
干预措施: mirabegron (Drug)
Treatment Arm 1
tamsulosin singles doses; mirabegron multiple dose
干预措施: tamsulosin (Drug)
Treatment Arm 2
mirabegron single doses; tamsulosin multiple dose
干预措施: mirabegron (Drug)
Treatment Arm 2
mirabegron single doses; tamsulosin multiple dose
干预措施: tamsulosin (Drug)
结局指标
主要结局
Cardiovascular interactions assessed by blood pressure and pulse rate
时间窗: Pre-dose until 24 hours after dosing
次要结局
- Potential PK interaction of the combination dosing assessed by serial plasma sampling(Arm 1: From time of combination dose until 4 days after combination dose (10 time points) / Arm 2: From time of combination dose until 8 days after combination dose (14 time points))
- Monitoring of safety and tolerability through assessment of vital signs, ECG, clinical safety laboratory and adverse events(Arm 1: From time of combination dose until 4 days after combination dose / Arm 2: From time of combination dose until 8 days after combination dose)