A Phase I, Single-Center, Open-label, Single Dose Pharmacokinetic and Tolerability Study of GZ402671 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
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Assessment of pharmacokinetic (PK) parameters of Venglustat: Area under the curve (AUC)
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 Venglustat following a single dose.
Secondary Objective:
To assess the tolerability of Venglustat 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
Approximately 41 days, including a 21-day screening period, a 1-day treatment period, followed by a 9-day period of plasma sampling for assessment of primary endpoints.
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 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
Venglustat
Single dose of Venglustat is given, orally under fasting conditions
干预措施: Venglustat GZ/SAR402671 (Drug)
结局指标
主要结局
Assessment of pharmacokinetic (PK) parameters of Venglustat: Area under the curve (AUC)
时间窗: Day 1 to Day 10
Venglustat area under the plasma concentration versus time curve (AUC)
次要结局
- Venglustat plasma pharmacokinetic (PK) parameter: AUClast(Day 1 to Day 10)
- Venglustat plasma pharmacokinetic (PK) parameter: t1/2eff(Day 1 to Day 10)
- Venglustat urine pharmacokinetic (PK) parameter: fe(0-24)(Day 1 and Day 2)
- Venglustat urine pharmacokinetic (PK) parameter: CLR(0-24)(Day 1 and Day 2)
- Venglustat plasma pharmacokinetic (PK) parameter: Rac,pred(Day 1 to Day 10)
- Venglustat plasma pharmacokinetic (PK) parameter: Cmax(Day 1)
- Venglustat plasma pharmacokinetic (PK) parameter: Vss/F(Day 1 to Day 10)
- Venglustat urine pharmacokinetic (PK) parameter: Ae(0-24)(Day 1 and Day 2)
- Venglustat plasma pharmacokinetic (PK) parameter: unbound Cmax(Day 1 to Day 10)
- Venglustat plasma pharmacokinetic (PK) parameter: unbound AUC(Day 1 to Day 10)
- Venglustat plasma pharmacokinetic (PK) parameter: CL/F(Day 1 to Day 10)
- Venglustat plasma pharmacokinetic (PK) parameter: fu(Day 1 to Day 10)
- Venglustat plasma pharmacokinetic (PK) parameter: t1/2z(Day 1 to Day 10)