NCT01478503已完成1 期
Double-blind, Randomized, Placebo-controlled, Dose-escalating, Exploratory Study to Investigate the Pharmacokinetics, Safety and Tolerability of Multiple Doses of YM178 OCAS-M in Healthy Young Male and Female Subjects and Healthy Elderly Male and Female Subjects
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
- 96
- 试验地点
- 2
- 主要终点
- Pharmacokinetics of mirabegron assessed by plasma concentration
研究概览
简要总结
The study aimed to compare age and gender differences for increasing doses of mirabegron when given to healthy young and elderly males and healthy young and elderly females.
详细描述
Each subject will receive a single dose of mirabegron OCAS-M or placebo on Day 2, followed by multiple dosing (qd) for 10 days (Day 5-14).
Young subjects will be divided into 4 groups and elderly subjects into 2 groups. Dosage will be different among groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy young subjects aged 18-55 years (inclusive)
- •Healthy elderly subjects aged 65-80 years (inclusive)
- •Body weight between 60.0 and 100.0 kg (male) or between 50.0 and 90.0 kg (female), and Body Mass Index between 18.0 and 30.0 kg/m2
排除标准
- •Known or suspected hypersensitivity to β-adrenergic receptor agonists or any components of the formulation used
- •Any of the liver function tests (i.e. ALT, AST and bilirubin) above the upper limit of normal at repeated measures
- •Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic as judged by the medical investigator.
- •Any clinically significant abnormality following the investigator's review of the pre-study physical examination, electrocardiogram (ECG) and clinical laboratory tests
- •Subjects taking β blockers or β agonists
- •Use of any prescribed or Over-the-counter (OTC) drugs (including vitamins, natural and herbal remedies, e.g. St. John's wort) in the 2 weeks prior to admission to the Clinical Unit, except for occasional use of paracetamol (up to 3 g/day)
- •Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampicin) in the 3 months prior to admission to the Clinical Unit
- •Donation of blood or blood products within 3 months prior to admission to the Clinical Unit
- •Any use of drugs of abuse, or smoking of more than 10 cigarettes (or equivalent) or more than 21 units of alcohol per week within the 3 months prior to study
- •Participation in any clinical study within 3 months or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study
研究组 & 干预措施
Treatment Arm A
Experimental
mirabegron
干预措施: mirabegron OCAS (Drug)
Treatment Arm B
Placebo Comparator
matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacokinetics of mirabegron assessed by plasma concentration
时间窗: Pre-dose until 72 hours after dosing
次要结局
- Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events(Baseline until 72 hours after dosing)
研究者
研究点 (2)
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