NCT06775834已完成1 期
Safety and Pharmacokinetic Study of HRS-1893 Tablets in Subjects With Mild and Moderate Renal Insufficiency and Healthy Subjects
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年2月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax)
研究概览
简要总结
The primary objective is to evaluate pharmacokinetics of HRS-1893 tablets in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sign the informed consent before the trial, and fully understand the content, process and possible adverse reactions of the trial;
- •Male or female subjects aged 18 to 65 (including 18 and 65);
- •Body mass index (BMI) ranges from 19 kg/m2 to 28 kg/m2 (including 18 and 28);
- •The glomerular filtration rate should meet the following criteria (GFR, mL/min): Subjects with mild renal impairment: 60-89 mL/min; Subjects with moderate renal impairment: 30-59 mL/min.
排除标准
- •Suspected allergy to the study drug or any component of the study drug;
- •Patients with cardiogenic shock, severe conduction block, sick sinus syndrome, heart failure, sustained tachyarrhythmia, torsades de pointes (Tdp) or ventricular tachycardia, history of clinically significant T wave changes, myocardial infarction, angina pectoris;
- •People with conditions associated with reduced neuromuscular transmission (myasthenia gravis, Lambert-Eaton syndrome, Duchenne muscular dystrophy);
- •Patients with a history of gastric or intestinal surgery that may affect drug absorption;
- •Participants with renal insufficiency who were judged by the investigator to be ineligible for the study;
- •Patients with large fluctuations or rapid deterioration of renal function within 2 weeks before administration, as judged by the investigator;
- •Subjects receiving renal replacement therapy within 3 months of the screening period or during the expected trial period;
- •Within 3 months before screening, patients with underlying diseases that induced chronic kidney disease and were poorly controlled according to the investigator's evaluation.
研究组 & 干预措施
Normal Renal Function Group
Experimental
干预措施: HRS-1893 (Drug)
Mild Renal Impairment Group
Experimental
干预措施: HRS-1893 (Drug)
Moderate Renal Impairment Group
Experimental
干预措施: HRS-1893 (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax)
时间窗: 0 hour to 16 days after the dosing.
Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration (AUC0-t)
时间窗: 0 hour to 16 days after the dosing.
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
时间窗: 0 hour to 16 days after the dosing.
次要结局
- Apparent clearance (CL/F)(0 hour to 16 days after the dosing.)
- Cumulative excretion (Ae)(0 hour to 16 days after the dosing.)
- Apparent volume of distribution (Vz/F)(0 hour to 16 days after the dosing.)
- Plasma protein binding rate (PPB)(0 hour to 16 days after the dosing.)
- Time to reach maximum plasma concentration (Tmax)(0 hour to 16 days after the dosing.)
- Terminal half-life (t1/2)(0 hour to 16 days after the dosing.)
- Incidence and severity of adverse events (AEs)(0 hour to 16 days after the dosing.)
研究者
研究点 (1)
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