A Double Blind, Randomized and Placebo Controlled Ascending Single Oral Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ASP1707 in Healthy Young Japanese Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety and tolerability measured by Adverse events (AE)
研究概览
简要总结
Three groups of 8 Japanese males are given single ascending doses of ASP1707 or placebo to assess the safety and tolerability, and to evaluate how it is absorbed, metabolized and distributed through the body.
详细描述
The first group receives the lowest dose while the last group receives the highest dose. ASP1707 or matching placebo is administered as a single dose under fasted conditions.
Screening takes place from Day -22 to Day -2. Subjects are admitted to the clinic on Day -1 and remain until Day 5. An end of study visit (ESV) takes place 7-14 days after discharge.
Escalation to the next higher dose takes place after review of the safety and tolerability data from the previous dose.
Safety assessments are performed throughout the study. Plasma and urine samples are collected for pharmacokinetics (PK) analysis. Serum samples are collected for pharmacodynamic (PD) analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Born in Japan
- •Both parents are of Japanese descent
- •Time residing outside Japan does not exceed 5 years
- •Maintains Japanese life style including diet
- •Male subject must be non-fertile, i.e. surgically sterilized or must practice an effective contraceptive method
排除标准
- •Subjects with out-of-range T levels in serum at screening
- •Subjects with any history of cancer
研究组 & 干预措施
1. ASP1707 lowest dose
干预措施: ASP1707 (Drug)
1. ASP1707 lowest dose
干预措施: Placebo (Drug)
2 ASP1707 higher dose
干预措施: ASP1707 (Drug)
2 ASP1707 higher dose
干预措施: Placebo (Drug)
3. ASP1707 Highest dose
干预措施: ASP1707 (Drug)
3. ASP1707 Highest dose
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability measured by Adverse events (AE)
时间窗: Day -2 to ESV (up to Day 19)
Safety and tolerability measured by physical examination (PE)
时间窗: Day -2 to ESV (up to Day 19)
Safety and tolerability measured by vital signs (VS)
时间窗: Day -2 to ESV (up to Day 19)
Safety and tolerability measured by laboratory tests
时间窗: Day -2 to ESV (up to Day 19)
Safety and tolerability measured by 12 lead electrocardiogram (ECG)
时间窗: Day -2 to ESV (up to Day 19)
次要结局
- Pharmacodynamics of Follicle-Stimulating Hormone (FSH) levels(Day -1 to ESV)
- PK profile of single ascending doses of ASP1707 in plasma(Days 1 to 5)
- PK profile of single ascending doses of ASP1707 in urine(Days 1 to 5)
- Pharmacodynamics of Testosterone (T)(Day -1 to ESV)
- Pharmacodynamics of Luteinizing Hormone (LH)(Day -1 to ESV)