A Phase 1, Open-label, Sequential Crossover Study to Evaluate the Effect of Hemodialysis on the Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- Cmax (maximum concentration) of JTZ-951 when administered before and after hemodialysis
研究概览
简要总结
The purpose of this study is to evaluate the effect of hemodialysis on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety of 2 doses of JTZ-951 in subjects with end-stage renal disease (ESRD) receiving hemodialysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have ESRD and have been receiving maintenance hemodialysis for at least 12 weeks prior to the Screening Visit
- •Body weight (post-dialysis weight) greater than 45.0 kg and a body mass index between 20.0 and 40.0 kg/m2 (inclusive) at the Screening Visit
排除标准
- •Acute coronary syndrome (e.g., myocardial infarction) within 1 year prior to admission
- •Uncontrolled hypertension at the Screening Visit or Day -1
研究组 & 干预措施
Dose 1 JTZ-951
Tablets, 1 dose on Day 1 before hemodialysis
干预措施: JTZ-951 (Drug)
Dose 2 JTZ-951
Tablets, 1 dose on Day 8 after hemodialysis
干预措施: JTZ-951 (Drug)
结局指标
主要结局
Cmax (maximum concentration) of JTZ-951 when administered before and after hemodialysis
时间窗: Days 1 to 4 and 8 to 11
AUC (area under the concentration-time curve) of JTZ-951 when administered before and after hemodialysis
时间窗: Days 1 to 4 and 8 to 11
tmax (time to reach maximum concentration) of JTZ-951 when administered before and after hemodialysis
时间窗: Days 1 to 4 and 8 to 11
t1/2 (elimination half-life) of JTZ-951 when administered before and after hemodialysis
时间窗: Days 1 to 4 and 8 to 11
次要结局
- Vital signs and ECG (electrocardiogram)(14 days)
- Number of subjects with adverse events(14 days)