Open-label, Cross Over, Single-sequence, Two Periods Phase 1 Drug-drug Interaction Study to Evaluate the Effects of Multiple-dose Mefenamic Acid, a Known UGT1A9 Inhibitor, on the Pharmacokinetics and Pharmacodynamics of Single-dose Sotagliflozin 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
- 16
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax)
研究概览
简要总结
Primary Objective:
To assess the effect of multiple dose mefenamic acid on the pharmacokinetics (PK) of sotagliflozin and its metabolite in healthy male and female subjects.
Secondary Objectives:
- To assess total 24 hour urinary glucose excretion (UGE) after 400 mg sotagliflozin alone and in combination with mefenamic acid in healthy male and female subjects.
- To assess the safety and tolerability of sotagliflozin alone and in combination with mefenamic acid in healthy male and female subjects.
详细描述
The expected duration of the study is approximately 59 days per subject, including 2-28 days of screening, treatment period 1 of 7 days, treatment period 2 of 8 days, at least 7 days of wash-out period, and an end of study visit, which is between 14-21 days after the last dose of sotagliflozin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
SAR439954 with or without mefenamic acid
Period 1: single oral dose of 400 mg sotagliflozin Period 2: initial loading dose of 500 mg in the morning of Day 1, followed by 250 mg from Day 1 H6 to Day 7 of mefenamic acid and a single oral dose of sotagliflozin on Day 2
干预措施: Sotagliflozin (SAR439954) (Drug)
SAR439954 with or without mefenamic acid
Period 1: single oral dose of 400 mg sotagliflozin Period 2: initial loading dose of 500 mg in the morning of Day 1, followed by 250 mg from Day 1 H6 to Day 7 of mefenamic acid and a single oral dose of sotagliflozin on Day 2
干预措施: Mefenamic acid (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax)
时间窗: Up to 144 hours after each SAR439954 intake
Area under the concentration-time curve from 0 to the last quantifiable concentration (AUClast)
时间窗: Up to 144 hours after each SAR439954 intake
Area under the concentration-time curve from 0 to infinity (AUC0 ∞)
时间窗: Up to 144 hours after each SAR439954 intake
次要结局
- Total 24-hour UGE (urinary glucose excretion) after each dose with sotagliflozin(Up to 24 hours after each SAR439954 intake)