NCT01083888已完成1 期
ASP1517 Clinical Pharmacological Study Examination of Pharmacokinetics and Pharmacodynamics in Patients With Renal Anemia Undergoing Hemodialysis
适应症
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
- 12
- 主要终点
- ASP1517 concentrations in plasma
研究概览
简要总结
To assess the Pharmacokinetics and pharmacodynamics of single doses of ASP1517 in renal anemia patients on hemodialysis. Safety and tolerability will be also evaluated in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic renal failure patients receiving hemodialysis thrice weekly
- •Body weight: >=40.0 and <80.0 kg
- •Mean hemoglobin level >=10.0 and =<12.0 g/dL
排除标准
- •Patients with severe inflammation or infection
- •Patients who have a medical history of gastrointestinal surgery or enterectomy
- •Patients who have uncontrolled hypertension
- •Patients whose AST, ALT, total bilirubin, GGT exceed the ULN or those who have a medical history of serious liver diseases
- •Patients who have a medical history of severe cardiac or cerebrovascular diseases
- •Patients who have received blood transfusion or who have had a surgery (except surgery for a shunt) within 4 weeks
- •Patients with a medical history of serious drug allergies
- •Patients who may be pregnant or lactating, or who refuse to use required birth control during the study period
研究组 & 干预措施
1 group
Experimental
Participants received a single oral dose of ASP1517 on Days 1 and 8
干预措施: roxadustat (Drug)
结局指标
主要结局
ASP1517 concentrations in plasma
时间窗: For 96 hours after dosing
次要结局
- ASP1517 concentrations in dialysate(For 6 hours after dosing)
- Plasma EPO level(Pre dosing and for 24 hours after dosing)
- Safety assessed by Adverse Event, vital signs standard 12-lead ECG or lab tests(For 96 hours after dosing)
研究者
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