A Phase 1 Study to Observe Safety and Tolerability of Single and Multiple Doses of TRK-820 in Subjects on Hemodialysis and to Observe the Effect on Uremic Pruritus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Pharmacokinetic parameters: time to maximum plasma concentration(Tmax)
研究概览
简要总结
This study is a 2-part study.
Part A is a single-dose, open-label study design to determine the PK, safety and tolerability of 5 μg TRK-820 oral administration in subjects with end-stage renal disease (ESRD) who require hemodialysis.
Part B is a multiple dose, open-label study design to determine the PK, PD, safety and tolerability of multiple doses in subjects with ESRD who require hemodialysis with refractory uremic pruritus (UP). Each subject will receive 3 doses of TRK-820 (2.5, 5 and 10 μg).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult non-smoking male and female subjects (≥ 18 years of age) who have ESRD requiring hemodialysis, at least 3 times a week.
- •Subjects has a clinical diagnosis of UP, which is uncontrolled by current medications or treatments.(Part B only)
排除标准
- •Subject has a known hypersensitivity to opioids or the ingredients of the study medication.
- •Subject has pruritus other than related to ESRD (i.e., UP).(Part B only)
研究组 & 干预措施
TRK-820
PartA: 5 μg PartB: 2.5-10 μg
干预措施: TRK-820 (Drug)
结局指标
主要结局
Pharmacokinetic parameters: time to maximum plasma concentration(Tmax)
时间窗: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacokinetic parameters: apparent elimination half-life in plasma(t½)
时间窗: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacokinetic parameters: area under the time curve from time zero extrapolated to infinity(AUC0-inf)
时间窗: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacokinetic parameters: maximum observed plasma concentration (Cmax)
时间窗: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacokinetic parameters: mean residence time(MRT)
时间窗: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacokinetic parameters: area under the time curve from time zero to 24 hours postdose(AUC0-24h)
时间窗: Part A; predose to 24 hours postdose, Part B; predose to 24 hours postdose each dose
Pharmacokinetic parameters: plasma concentration at 24 hours postdose(C24h)
时间窗: Part A; 24 hours postdose, Part B; 24 hours postdose each dose
Pharmacokinetic parameters: terminal elimination rate(λz)
时间窗: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacokinetic parameters: apparent total clearance(CL/F)
时间窗: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacokinetic parameters: apparent distribution volume(Vz/F)
时间窗: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacodynamic parameters: Visual Analogue Scale (VAS) reduction from baseline
时间窗: Part B only; Baseline to week 5
Pharmacokinetic parameters: area under the time curve from time zero to the last quantifiable concentration(AUC0-last)
时间窗: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
次要结局
未报告次要终点