Clinical Pharmacology Study of FYU-981 for Subjects With Hepatic Insufficiency
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
研究概览
简要总结
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with hepatic insufficiency and with normal hepatic function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult healthy subjects or adult cirrhosis patients
- •Body mass index: >=18.5 and <30.0
排除标准
- •Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study (except for cirrhosis patients with hepatic diseases)
研究组 & 干预措施
Normal group
Healthy control subjects
干预措施: FYU-981 (Drug)
Mild hepatic-insufficient group
Patients with mild hepatic impaired function (Child-Pugh A)
干预措施: FYU-981 (Drug)
Moderate hepatic-insufficient group
Patients with moderate hepatic impaired function (Child-Pugh B)
干预措施: FYU-981 (Drug)
Severe hepatic-insufficient group
Patients with severe hepatic impaired function (Child-Pugh C)
干预措施: FYU-981 (Drug)
结局指标
主要结局
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
时间窗: 48 hours
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
时间窗: 48 hours
Pharmacokinetics (MRT: Mean residence time)
时间窗: 48 hours
Pharmacodynamics (Serum concentration of uric acid)
时间窗: 48 hours
Pharmacokinetics (Cmax: Maximum plasma concentration)
时间窗: 48 hours
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
时间窗: 48 hours
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
时间窗: 48 hours
Safety (Incidence of treatment-emergent adverse events)
时间窗: 192 hours
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
时间窗: 48 hours
Pharmacodynamics (Amount of uric acid excreted in urine)
时间窗: 48 hours
Pharmacokinetics (kel: Elimination rate constant)
时间窗: 48 hours
次要结局
未报告次要终点