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临床试验/NCT01978587
NCT01978587已完成1 期

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

Akros Pharma Inc.0 个研究点目标入组 6 人开始时间: 2013年10月最近更新:
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
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

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

Experimental

Tablets, 1 dose on Day 1 before hemodialysis

干预措施: JTZ-951 (Drug)

Dose 2 JTZ-951

Experimental

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)

研究者

申办方类型
Industry
责任方
Sponsor

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