NCT02471274已完成1 期
A Phase 1, Open-label, Parallel-group Study to Evaluate the Single-dose Pharmacokinetics of Sotagliflozin in Male and Female Subjects With Mild, Moderate, and Severe Hepatic Impairment and Matched Subjects With Normal Hepatic Function
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters
研究概览
简要总结
To evaluate the effect of mild, moderate, or severe hepatic impairment on the pharmacokinetics (PK) of a single dose of 400 mg sotagliflozin (2 x 200-mg tablets) compared with healthy, demographically-matched subjects.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult male and female subjects ≥18 to ≤70 years of age
- •Body mass index ≥18.0 to ≤36.0 kg/m2, inclusive, at Screening
- •Subjects with mild, moderate, or severe hepatic impairment
- •Control group of matched healthy subjects
- •Willing and able to provide written informed consent
排除标准
- •Presence of clinically significant physical, laboratory, or ECG findings that may interfere with any aspect of study conduct or interpretation of results
- •Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of sotagliflozin
- •History of any major surgery within 6 months
- •History of renal disease, or significantly abnormal kidney function test
- •Women who are breastfeeding or are planning to become pregnant during the study
研究组 & 干预措施
Group 3
Experimental
subjects with moderate hepatic impairment
干预措施: sotagliflozin (Drug)
Group 4
Experimental
subjects with severe hepatic impairment
干预措施: sotagliflozin (Drug)
Group 1
Experimental
healthy control subjects with normal hepatic function
干预措施: sotagliflozin (Drug)
Group 2
Experimental
subjects with mild hepatic impairment
干预措施: sotagliflozin (Drug)
结局指标
主要结局
Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters
时间窗: Day 1 to Day 5
次要结局
- Number of treatment emergent adverse events(Day 1 to Day 8)
研究者
研究点 (1)
Loading locations...
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