Single Dose Clinical Pharmacological Study of FYU-981 Administered to Healthy Male Adults (Phase I Study).
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (Cmax: Maximum plasma concentration)
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of FYU-981 administered orally to healthy male adults in fasted and fed conditions. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in each step. After follow-up examination in the step of lower dose, the next dose is administered. The effect of food on PK/PD of FYU-981 is also investigated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Japanese healthy adult subjects
- •Body mass index: >=18.5 and <25.0
排除标准
- •Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study
研究组 & 干预措施
FYU-981
干预措施: FYU-981, (Oral single dosing) (Drug)
Placebo
干预措施: Placebo, (Oral single dosing) (Drug)
结局指标
主要结局
Pharmacokinetics (Cmax: Maximum plasma concentration)
时间窗: 48 hours
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
时间窗: 48 hours
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
时间窗: 48 hours
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
时间窗: 48 hours
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
时间窗: 48 hours
Pharmacokinetics (kel: Elimination rate constant)
时间窗: 48 hours
Pharmacokinetics (MRT: Mean residence time)
时间窗: 48 hours
Pharmacokinetics (Ae: Amount of drug excreted in urine)
时间窗: 48 hours
Pharmacokinetics (fe: Fraction of dose excreted in urine)
时间窗: 48 hours
Pharmacokinetics (CLr: Renal clearance)
时间窗: 48 hours
次要结局
未报告次要终点