A Two-cohort, Open-label, Fixed-sequence, Two-period, Two-treatment Pharmacokinetic Interaction Study of Repeated Oral Doses of Sotagliflozin on a Single Dose Cocktail of Metoprolol and Midazolam Used as Probe Substrates for CYP2D6 and CYP3A Activities, Respectively, in Healthy Subjects
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
- Assessment of midazolam pharmacokinetic (PK) parameter: Area under the curve (AUC)
研究概览
简要总结
Primary Objective:
To assess the effect of repeated once-daily oral doses of sotagliflozin on CYP2D6 and CYP3A activities using a CYP probe cocktail of metoprolol and midazolam.
Secondary Objective:
To assess the clinical and laboratory safety of sotagliflozin coadministered with the cocktail probes as compared to that of cocktail probes alone.
详细描述
The total study duration per subject is up to 58 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
Cohort 2
Participants will initially be given with treatment A (cocktail of metoprolol and midazolam) and then will start with treatment B (Dose 2 of Sotagliflozin plus cocktail) after 3 days
干预措施: midazolam (Drug)
Cohort 1
Participants will initially be given with treatment A (cocktail of metoprolol and midazolam) and then will start with treatment B (Dose 1 of Sotagliflozin plus cocktail) after 3 days
干预措施: sotagliflozin (SAR439954) (Drug)
Cohort 1
Participants will initially be given with treatment A (cocktail of metoprolol and midazolam) and then will start with treatment B (Dose 1 of Sotagliflozin plus cocktail) after 3 days
干预措施: midazolam (Drug)
Cohort 1
Participants will initially be given with treatment A (cocktail of metoprolol and midazolam) and then will start with treatment B (Dose 1 of Sotagliflozin plus cocktail) after 3 days
干预措施: metoprolol (Drug)
Cohort 2
Participants will initially be given with treatment A (cocktail of metoprolol and midazolam) and then will start with treatment B (Dose 2 of Sotagliflozin plus cocktail) after 3 days
干预措施: sotagliflozin (SAR439954) (Drug)
Cohort 2
Participants will initially be given with treatment A (cocktail of metoprolol and midazolam) and then will start with treatment B (Dose 2 of Sotagliflozin plus cocktail) after 3 days
干预措施: metoprolol (Drug)
结局指标
主要结局
Assessment of midazolam pharmacokinetic (PK) parameter: Area under the curve (AUC)
时间窗: Day 1 to Day 2 of Treatment A Period
Assessment of midazolam PK parameter: AUC
时间窗: Day 11 to Day 12 of Treatment B Period
Assessment of metoprolol PK parameter: AUC
时间窗: Day 11 to Day 13 of Treatment B Period
次要结局
- Assessment of PK parameter: Tmax(Day 11 to Day 13 of Treatment B Period (metoprolol))
- Assessment of PK parameter: Cmax(Day 11 to Day 13 of Treatment B Period (metoprolol))
- Assessment of PK parameter: time to reach Cmax (Tmax)(Day 1 to Day 2 of Treatment A Period (midazolam))
- Assessment of PK parameter: t1/2z(Day 11 to Day 13 of Treatment B Period (metoprolol))
- Assessment of PK parameter: maximum plasma concentration (Cmax)(Day 1 to Day 2 of Treatment A Period (midazolam))
- Assessment of PK parameter: terminal-half life (t1/2z)(Day 1 to Day 2 of Treatment A Period (midazolam))