JPRN-jRCT2080224682已完成1 期
The Pharmacokinetics study of Imeglimin (PXL008) in Japanese Subjects with Renal Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
The Cmax and AUC increased in association with the degree of renal impairment. No adverse events were observed and tolerability was confirmed.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 79age old（—）
- 性别
- All
入选标准
- •Main inclusion criteria:
- •-Subjects who meet any of the following eGFR (mL/min/1.73 m2) at screening and the day before study drug administration
- •Normal Renal Function: more than or equal to 90
- •Mild renal impairment: more than or equal to 60, less than 90
- •Moderate renal impairment: more than or equal to 30, less than 60
- •Severe renal impairment: more than or equal to 15, less than 30
- •-Subjects who require no dialysis
排除标准
- •Main exclusion criteria:
- •-Subjects who are diagnosed with an acute deterioration in renal function within 4 weeks (28 days) before screening based on symptoms or laboratory tests.
- •-Subjects with hemoglobin less than 8.0 g/dL at screening.
- •-Subjects who have received peritoneal dialysis or hemodialysis between screening and the day before study drug administration.
研究者
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