NCT01334905已完成1 期
A Phase 1, Open-Label, Single Oral Dose Study to Assess the Safety, Pharmacokinetics and Effect of Food on the Pharmacokinetics of Mirabegron (YM178) in Healthy 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
- 12
- 主要终点
- Maximum plasma concentration (Cmax) of YM178
研究概览
简要总结
The purpose of the study is to evaluate safety of YM178 and the effect of food intake on the pharmacokinetics of YM178 in healthy adult subjects.
详细描述
A open-label, randomized, crossover study to assess the effect of food on the pharmacokinetics of single dose of YM178 administered under fasted and fed conditions.
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
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A normal or clinically non-significant 12 lead ECG as well as normal or clinically non-significant laboratory test results at the time of Screening
- •Body weigh at least 50 kg in male and 45 kg in female and body mass index (BMI) between 18.5 and 26.9 kg/m2
- •All women of child bearing potential are required to use adequate contraception consisting of two forms of birth control
排除标准
- •Hypersensitivity to YM178 or other beta-3 agonists or any of the constituents of the formulation used
- •Liver function test values above the upper limit of normal
- •A history or presence of psychiatric illness, serious active or recurrent infection
- •A previous history of cancer other than basal cell carcinoma or Stage 1 squamous cell carcinoma that has not been in remission for at least 5 years prior to the study
- •Donated or lost ≥ 500 mL blood within 3 months or donated plasma within 2 weeks prior to the study
- •Receiving or being anticipated to receive a prescription drug or OTC medications within 14 days prior to the study
- •Consuming alcohol, xanthine derivative-containing food/beverages (tea, chocolate), grapefruit juice, grapefruit-containing products or Seville oranges (e.g., bitter marmalade) within 48 hours before the study
- •A history of substance abuse, drug addiction, or alcoholism within past 2 years prior to the study
- •currently participating in another clinical trial or taking or has been taking an investigational drug at least 60 days
研究组 & 干预措施
Part A group
Experimental
fasted condition then fed condition
干预措施: YM178 (Drug)
Part B group
Experimental
fed condition then fasted condition
干预措施: YM178 (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax) of YM178
时间窗: Up to 96 hrs post dose
AUC (area under the curve) of YM178 plasma concentration
时间窗: Up to 96 hrs post dose
次要结局
- tmax of YM178 plasma concentration(Up to 96 hrs post dose)
- t1/2 of YM178 plasma concentration(Up to 96 hrs post dose)
- Safety assessed by the incidence of adverse events, clinical lab tests, vital signs, 12-lead ECGs and physical exam.(Up to 96 hrs post dose)
研究者
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