An Open-label Two-stage Pharmacokinetic and Tolerability Study of Eliglustat Tartrate Given as a Single Dose in Subjects With Mild, Moderate and Severe Renal Impairment, and in Matched Subjects With Normal Renal Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- - Assessment of PK parameter: Maximum plasma concentration observed (Cmax)
研究概览
简要总结
Primary Objective:
To study the effect of mild, moderate, and severe renal impairment on the pharmacokinetics (PK) of eliglustat.
Secondary Objective:
To assess the tolerability of eliglustat tartrate given as a single dose in subjects with mild, moderate, and severe renal impairment in comparison with matched subjects with normal renal function.
详细描述
The total study duration from screening period is approximately 31 days. In stage 1, only subjects with severe renal impairment and normal renal function will be enrolled. Subjects with mild and moderate renal impairment may be enrolled in stage 2 if the results in subjects with severe renal impairment show a substantial effect of reduced renal function on pharmacokinetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
GZ385660 (healthy subjects)
Single dose of eliglustat tartrate will be given under fed conditions
干预措施: eliglustat (Drug)
GZ385660 (subjects with mild renal impairment)
Single dose of eliglustat tartrate will be given under fed conditions
干预措施: eliglustat (Drug)
GZ385660 (subjects with moderate renal impairment)
Single dose of eliglustat tartrate will be given under fed conditions
干预措施: eliglustat (Drug)
GZ385660 (subjects with severe renal impairment)
Single dose of eliglustat tartrate will be given under fed conditions
干预措施: eliglustat (Drug)
结局指标
主要结局
- Assessment of PK parameter: Maximum plasma concentration observed (Cmax)
时间窗: 3 days
- Assessment of PK parameter: Area under the plasma concentration (AUC)
时间窗: 3 days
次要结局
- Assessment of PK parameter: Apparent total body clearance (CL/F)(3 days)
- Assessment of PK parameter: Area under the plasma concentration versus time curve (AUClast)(3 days)
- Assessment of PK parameter: Apparent volume of distribution during the terminal phase (Vz/F)(3 days)
- Assessment of PK parameter: Predicted accumulation ratio (Rac,pred)(3 days)
- Assessment of PK parameter: Terminal half-life (t1/2z)(3 days)
- Number of adverse events(Up to 10 days)