A Phase 1, Single-center, Open-label, 2-period, Single Sequence Drug-drug Interaction Study to Evaluate the Effects of Multiple-dose Rifampicin 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
- Area under the concentration-time curve from 0 to the last quantifiable concentration (AUC0-tlast)
研究概览
简要总结
Primary Objective:
To evaluate the effects of rifampicin 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 a dose of sotagliflozin 400 mg, alone and with rifampicin, in healthy male and female subjects.
- To assess the safety and tolerability of single dose sotagliflozin with and without rifampicin in healthy male and female subjects.
详细描述
The expected duration of the study is approximately 53 days total, including 2-28 days of screening, treatment periods of 6 days and 11 days, 1 day of end of study visit, and at least 7 days of follow-up visit.
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 rifampicin
Period 1: single oral dose of 400 mg sotagliflozinon Day 1 morning Period 2: once-daily oral doses of 600 mg rifampicin from Days 1 to 10 and a single oral dose of 400 mg sotagliflozin
干预措施: Rifampicin (Drug)
SAR439954 with or without rifampicin
Period 1: single oral dose of 400 mg sotagliflozinon Day 1 morning Period 2: once-daily oral doses of 600 mg rifampicin from Days 1 to 10 and a single oral dose of 400 mg sotagliflozin
干预措施: Sotagliflozin (SAR439954) (Drug)
结局指标
主要结局
Area under the concentration-time curve from 0 to the last quantifiable concentration (AUC0-tlast)
时间窗: Up to 96 hours post SAR439954 dosing
Maximum plasma concentration (Cmax)
时间窗: Up to 96 hours post SAR439954 dosing
Area under the concentration-time curve from 0 to infinity (AUC0 ∞)
时间窗: Up to 96 hours post SAR439954 dosing
次要结局
- Total 24-hour UGE (urinary glucose excretion)(Up to 24 hours after SAR439954 intake)