NCT06849778已完成1 期
A Phase 1, Open-label, Pharmacokinetic Study of TS-172 in Patients on Hemodialysis
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
- 7
- 试验地点
- 1
- 主要终点
- Concentration of unchanged form in plasma
研究概览
简要总结
A phase 1, open-label, pharmacokinetic study of TS-172 in patients on hemodialysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Japanese male patients (outpatients) with chronic kidney disease receiving hemodialysis (HD or HDF) 3 times a week for at least 12 weeks prior to the screening test
- •Patients aged >= 18 and < 75 years at the time of obtaining informed consent
排除标准
- •Patients with gastric or intestinal ulceration or a history of them within the past year prior to the date of initiation of treatment, or patients with inflammatory bowel disease or irritable bowel syndrome, or a history of these within the past 5 years prior to the date of initiation of treatment
- •Patients scheduled for renal transplantation, home hemodialysis or change of dialysis facility (transfer or temporary dialysis at other hospital) during the study period
- •Patients who frequently experience diarrhea (defined as Bristol Stool Scale score of 6 or higher)
研究组 & 干预措施
TS-172
Experimental
干预措施: TS-172 (Drug)
结局指标
主要结局
Concentration of unchanged form in plasma
时间窗: Day 1, 2, 8 and 9
Concentration of major metabolites in plasma
时间窗: Day 1, 2, 8 and 9
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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