A Phase 1, Open-label, Parallel-group Study to Evaluate Sotagliflozin Safety and Pharmacokinetics in Subjects With Varying Degrees of Renal Function

Lexicon Pharmaceuticals1 个研究点分布在 1 个国家目标入组 50 人开始时间: 2015年12月最近更新: 2019年2月26日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Lexicon Pharmaceuticals
入组人数: 50
试验地点: 1
主要终点: Number of treatment emergent adverse events

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the effect of mild, moderate, or severe renal impairment, or end-stage renal disease (ESRD) requiring hemodialysis (HD), on the safety and tolerability of 1 or 2 single doses of sotagliflozin compared with healthy, demographically-matched subjects with normal renal function.

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 75 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 ≤75 years of age
•Body mass index ≥18.0 to ≤36.0 kg/m2, at Screening
•Subjects with mild, moderate, or severe renal impairment, or ESRD requiring HD
•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 hepatic disease, or significantly abnormal liver function test
•Women who are breastfeeding or are planning to become pregnant during the study