NCT01121198已完成1 期
ASP1941 Phase I Study -Placebo-controlled, Single-dose and Repeated-dose Oral Administration Study in Healthy Adult Male 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
- 84
- 主要终点
- Safety assessed by adverse events, vital signs, 12-lead ECG and lab-tests
研究概览
简要总结
This study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 in healthy adult male subjects.
详细描述
This study consists of two parts. In part-1, a single oral dose of ASP1941 or placebo is administered to healthy adult male subjects to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy adult males. In part-2, ASP1941 or placebo are is administered by a multiple dose regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 44 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body weight: 50.0 kg ≤ weight < 85.0 kg
- •Body mass index:17.6 ≤ BMI < 26.4
- •Those who provided written informed consent themselves
排除标准
- •Medical history of Hepatic disease, heart disease, respiratory disease, gastrointestinal disease, renal disease, cerebrovascular disease, malignant tumor or drug allergy
- •Those whose blood pressure, pulse rate, body temperature or 12-lead ECG are in the abnormal range
- •Those whose lab-test results are in the abnormal range
- •Those who received medical treatment within 14 days prior to the study
- •Those who attended another clinical study or a post-marketing clinical trial within 120 days before the study
- •Those who have received ASP1941 before
- •Those who have donated at least 400ml of whole blood within 90 days before the study, at least 200ml 30 days before the study or blood component within 14 days before the study
- •Those within a fasting plasma glucose level of < 70mg/dL or 110 mg/dL or with an HbA1C. 5.8%
研究组 & 干预措施
placebo repeated arm
Placebo Comparator
干预措施: placebo (Drug)
placebo single arm
Placebo Comparator
干预措施: placebo (Drug)
ASP1941 single arm
Experimental
干预措施: ASP1941 (Drug)
ASP1941 repeated arm
Experimental
干预措施: ASP1941 (Drug)
结局指标
主要结局
Safety assessed by adverse events, vital signs, 12-lead ECG and lab-tests
时间窗: 72 hours after drug administration
次要结局
- Blood glucose level measured by blood sample(72 hours after drug administration)
- Plasma concentration of unchanged drug measured by blood sample(72 hours after drug administration)
- Urinary glucose excretion level(72 hours after drug administration)
研究者
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