NCT03909451已完成1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Determine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Orally Administered Sotagliflozin in Healthy Chinese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
Primary Objective:
To assess the safety and tolerability of sotagliflozin after a multiple oral dose administration in Chinese healthy subjects.
Secondary Objectives:
- To assess the pharmacokinetic (PK) parameters of sotagliflozin after a multiple oral dose administration in Chinese healthy subjects.
- To assess the pharmacodynamics (PD) parameters of absolute urinary glucose excretion after a multiple oral dose administration in Chinese healthy subjects.
详细描述
The study duration per subject will be up to 41 days and will consist of a screening period of up to 28 days, a dosing period of 8 days, and a follow up visit 5 days after last dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（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
Dose 1
Experimental
Sotagliflozin dose 1, once daily for 8 days
干预措施: Sotagliflozin (SAR439954) (Drug)
Dose 2
Experimental
Sotagliflozin dose 2, once daily for 8 days
干预措施: Sotagliflozin (SAR439954) (Drug)
Placebo
Placebo Comparator
Placebo, once daily for 8 days
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse events (AEs)
时间窗: Up to 41 days
Proportion of patients who experienced adverse events/treatment-emergent AEs (TEAE)
次要结局
- Assessment of PK parameter: Maximum plasma concentration (Cmax)(On Day 1 and from Day 8 to Day 13)
- Assessment of PK parameter: Area under curve from 0 to 24 hours (AUCtau)(On Day 1 and Day 8)
- Assessment of PK parameter: Area under the concentration-time curve (AUC)(From Day 8 to Day 13)
- Assessment of PD parameter: urinary glucose excretion (UGE)(On Day 1 and Day 8)
研究者
研究点 (1)
Loading locations...
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