JPRN-jRCT2080224863已完成2 期
A multi-center, open-label clinical pharmacology study to evaluate the pharmacokinetics, pharmacodynamics and safety of TMX-049 multiple oral administration in subjects with normal renal function or impaired renal function.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
Plasma exposure of TMX-049 tended to increase in patients with severe renal impairment compared to those with normal renal function, but no clear difference was observed in patients with moderate renal impairment. In both severe and moderate renal impairment groups, changes from baseline in serum uric acid levels after the TMX-049 administration were smaller than those in the normal renal function group. No specific safety concerns were identified in any of the groups.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old(—)
- 性别
- Male
入选标准
- •Estimated eGFR(mL/min/1.73 m2) * within the categories shown below
- •1)Severe renal impairment: 10 =< eGFR < 30
- •2)Moderate renal impairment: 30 =< eGFR < 60
- •3)Normal renal function: 90 =< eGFR
- •*: calculated using the eGFRcreat Formula
- •-Serum urate => 5.0 mg/dL
排除标准
- •-Patients who have gouty arthritis
- •-Patients who have malignant tumor
- •-Patients who have severe hepatic insufficiency
- •-Patients who have poor blood pressure control
- •-Patients who have poor glycaemic control
研究者
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