NCT01288898已完成1 期
A Double-blind, Placebo-controlled, Dose Escalating Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of ASP1941 and to Explore the Effect of ASP1941 on Urine and Blood Glucose Levels in Healthy Subjects
适应症
相关药物
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
- Safety and Tolerability assessed by the incidence of adverse events, vital signs, physical examinations, 12-lead ECG and lab-tests
研究概览
简要总结
This study determined the safety of ASP1941 after a single and multiple once-daily doses for 10 days in healthy subjects. In addition, the Pharmacokinetics (PK) and Pharmacodynamics (PD) of ASP1941 were assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body weight between 60-100kg, body mass index (BMI) between 20-30 kg/m2, inclusive
排除标准
- •Fasting Plasma Glucose (FPG) > 6.4 mmol/l
- •HbA1c > 6.2%
- •Abnormal pulse of blood pressure at screening, as judged by the investigator
结局指标
主要结局
Safety and Tolerability assessed by the incidence of adverse events, vital signs, physical examinations, 12-lead ECG and lab-tests
时间窗: 31 days
次要结局
- Pharmacokinetics assessed by the ASP1941 plasma concentration change(up to 96 hours after last dose)
- Pharmacodynamics assessed by the ASP1941 glucose concentration changes in blood and urine(up to 96 hours after last dose)
研究者
研究点 (1)
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