A Phase 1, Randomized, Single-center, Open-label, Three-sequence, Three-period, Three-treatment Crossover Study to Evaluate the Effect of Food on the Single-dose Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability of Sotagliflozin Oral Tablet to Oral Solution in Healthy Male and Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Area under curve (AUC) of sotagliflozin
研究概览
简要总结
Primary Objective:
To evaluate the effect of food on the single-dose pharmacokinetics of sotagliflozin relative to a fasted state in healthy adult male and female subjects.
Secondary Objectives:
- To evaluate the effect of food on the single-dose pharmacokinetics of the main metabolite (sotagliflozin 3-O-glucuronide) relative to a fasted state in healthy adult male and female subjects.
- To investigate the relative bioavailability of sotagliflozin tablet to oral solution under fasting conditions
- To evaluate safety and tolerability of single-dose sotagliflozin under fed and fasted conditions in healthy adult male and female subjects.
详细描述
The study duration per subject will be 26 to 83 days and will consist of a screening period of 2-28 days, a treatment period of 6 days each for Periods 1, 2 and 3, a washout between treatment periods of 1-14 days, and follow up visit 10-15 days after the last Investigational Medicinal Product administration in period 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 55 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
Fed Tablet period (Test, T)
Sotagliflozin oral in fed conditions
干预措施: Sotagliflozin (SAR439954) (Drug)
Fasted Tablet period (Reference, R)
Sotagliflozin oral in fasting conditions
干预措施: Sotagliflozin (SAR439954) (Drug)
Oral Solution period (S)
Sotagliflozin oral solution in fasting conditions
干预措施: Sotagliflozin (SAR439954) (Drug)
结局指标
主要结局
Area under curve (AUC) of sotagliflozin
时间窗: From 0 to 120 hours after sotagliflozin intake
Maximum plasma drug concentration (Cmax) of sotagliflozin
时间窗: From 0 to 120 hours after sotagliflozin intake
次要结局
- Sotagliflozin-O-glucuronide (tablet and oral solution): Area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast)(From 0 to 120 hours after sotagliflozin intake)
- Sotagliflozin (tablet and oral solution):Apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F)(From 0 to 120 hours after sotagliflozin intake)
- Sotagliflozin (tablet and oral solution): Elimination half-life (t1/2z)(From 0 to 120 hours after sotagliflozin intake)
- Sotagliflozin (tablet and oral solution): Time to reach maximum plasma concentration (tmax)(From 0 to 120 hours after sotagliflozin intake)
- Sotagliflozin-O-glucuronide (tablet and oral solution): Cmax(From 0 to 120 hours after sotagliflozin intake)
- Sotagliflozin-O-glucuronide (tablet and oral solution): tmax(From 0 to 120 hours after sotagliflozin intake)
- Sotagliflozin-O-glucuronide (tablet and oral solution): AUC(From 0 to 120 hours after sotagliflozin intake)
- Relative bioavailability (Frel)(From 0 to 120 hours after sotagliflozin intake)
- Number (%) of subjects with treatment emergent adverse events(Over 9 weeks)
- Sotagliflozin-O-glucuronide (tablet and oral solution): t1/2z(From 0 to 120 hours after sotagliflozin intake)