NCT06961643已完成1 期
Investigation of Pharmacokinetics and Safety of HRS-7535 in Subjects With Mild and Moderate Hepatic Impairment and Normal Hepatic Function
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6月5日最近更新:
适应症
干预措施
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
- The maximum plasma concentration of HRS-7535 (Cmax)
研究概览
简要总结
The study is being conducted to compare the pharmacokinetics and safety of HRS-7535 in subjects with mild to moderate hepatic impairment and normal hepatic 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to understand the study procedures and methods, participate voluntarily and be able to complete the study according to the protocol requirements, and sign the informed consent form (ICF) in writing.
- •Aged 18-70 years old on the date of signing the ICF (including the threshold), both male and female.
- •At the time of screening, male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg; body mass index (BMI): 18~32 kg/m2 (including the threshold).
排除标准
- •In the judgment of the investigator, may be allergic to the study drug or its components.
- •Smoking an average of more than 10 cigarettes per day within 3 months prior to screening.
- •Alcoholics of within 3 months prior to screening, who consume more than 14 units of alcohol per week (1 unit=beer)360 mL of alcohol, or 45 mL of strong liquor with an alcohol content of 40%, or 150 mL of wine.
- •History of drug or substance abuse, or a positive urine drug test at screening.
- •Donated or lost ≥ 400 mL of blood within 3 months prior to screening.
- •Individuals with a history of severe hypoglycemia.
- •Undergone surgery within 6 months prior to screening, or plan to undergo surgery during the trial period.
研究组 & 干预措施
Treatment group C
Experimental
Subjects with normal hepatic function.
干预措施: HRS-7535 Tables (Drug)
Treatment group A
Experimental
Subjects with mild hepatic impairment.
干预措施: HRS-7535 Tables (Drug)
Treatment group B
Experimental
Subjects with moderate hepatic impairment.
干预措施: HRS-7535 Tables (Drug)
结局指标
主要结局
The maximum plasma concentration of HRS-7535 (Cmax)
时间窗: Post-dose at day 1 to day 4.
Area under the concentration curve from time 0 to the last quantifiable concentration (AUC0-t)
时间窗: Post-dose at day 1 to day 4.
Area under the concentration curve from time 0 to extrapolated infinite time (AUC0-inf)
时间窗: Post-dose at day 1 to day 4.
次要结局
- Time to maximum plasma concentration (Tmax)(Post-dose at day 1 to day 4.)
- Terminal half-life (t1/2)(Post-dose at day 1 to day 4.)
- Apparent clearance (CL/F)(Post-dose at day 1 to day 4.)
- Apparent volume of distribution (Vz/F)(Post-dose at day 1 to day 4.)
- Adverse events (AEs)(Screening period up to Day 7.)
研究者
研究点 (1)
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