NCT00978198已完成1 期
ASP1517 Phase 1 Clinical Study - Single and Multiple Oral Dosing of ASP1517 in Healthy Non-elderly Male 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
- 100
- 主要终点
- Safety and tolerability of ASP1517
研究概览
简要总结
The purpose of the study is to evaluate the safety and tolerability of ASP1517 after single or multiple oral administration in healthy non-elderly adult male subjects.
详细描述
The study consists of two parts, single and multiple dose. Within each part participants will be randomized to either ASP1517 or placebo.
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, <80.0 kg
- •BMI: ≥18.5 kg/m2, <25.0 kg/m2
- •Eligible, as judged by the investigator/subinvestigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained at screening and up to the timing immediately before study medication
- •Supine blood pressure: Systolic blood pressure ≥90 mmHg, ≤130 mmHg; Diastolic blood pressure ≤85 mmHg
- •Pulse rate at rest in supine position: ≥40 bpm, <100 bpm
排除标准
- •Received any investigational drugs in other clinical or post-marketing studies within 120 days before the screening assessment
- •Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening assessment
- •Received medication within 7 days before hospital admission or is scheduled to receive medication
- •History of drug allergies
- •Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before the study
- •Excessive smoking or drinking habit (measure of "excessive": alcohol: 45 g/day, smoking: 20 cigarettes/day)
研究组 & 干预措施
Part 2
Experimental
multiple administration
干预措施: ASP1517 (Drug)
Part 1
Experimental
single administration
干预措施: ASP1517 (Drug)
Part 1
Experimental
single administration
干预措施: Placebo (Drug)
Part 2
Experimental
multiple administration
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of ASP1517
时间窗: During 2 weeks
次要结局
- Pharmacokinetics of ASP1517(During 2 weeks)
研究者
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