A Pharmacokinetic Study of D-2570 in Participants With Hepatic Impairment and Normal Hepatic Function
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The main PK parameters -Time to maximum measured plasma concentration -Tmax Population pharmacokinetic characteristics of D-2570
研究概览
简要总结
This is a single-center, non-randomized, open-label, parallel-group study. It will test D-2570 in people with liver problems and in people with healthy livers, to see how the drug moves through the body and whether it is safe.
详细描述
This is a single-center, non-randomized, open-label, parallel-controlled study designed to evaluate the pharmacokinetic profile and safety of D-2570 in participants with hepatic impairment and those with normal hepatic function. Participants with hepatic impairment will be enrolled first, followed by participants with 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
- Basic Science
- 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
- •Voluntarily participate in this study and sign the written informed consent form after full informed consent, and agree to comply with the procedures specified in the study protocol.
- •Aged 18 to 70 years.
- •Both males and females are eligible.
- •Male participants must weigh no less than 50 kg, and female participants must weigh no less than 45 kg.
- •Participants with normal hepatic function must have adequate hematologic, renal, and hepatic function.
- •Have no plan to reproduce or donate sperm/eggs from screening until 30 days after the last dose of study drug, and agree to either completely abstain from sexual intercourse or use effective contraceptive measures from screening until 30 days after the last dose of study drug, as detailed in Appendix 3.
排除标准
- •Have undergone any prior surgery that may affect drug absorption, distribution, metabolism, or excretion, which, in the opinion of the investigator, would make the participant unsuitable for enrollment.
- •Are female and currently lactating, or have a positive serum pregnancy test result at screening or during the study period.
- •Have a known history of drug or substance abuse, or test positive for drugs of abuse on the urine drug screen.
- •Have participated in another interventional clinical trial within 3 months prior to screening, or are currently participating in another clinical trial (participants who withdraw from a prior trial before treatment, i.e., were not randomized or did not receive study intervention, may be enrolled in this study).
- •Have received a live vaccine within 2 months prior to study drug administration, or intend to receive a live vaccine during the study period.
- •Have any other condition or finding that, in the opinion of the investigator, would make the participant unsuitable for participation in this study.
结局指标
主要结局
The main PK parameters -Time to maximum measured plasma concentration -Tmax Population pharmacokinetic characteristics of D-2570
时间窗: Up to 192 hours after the last dose
The main PK parameters -Time to maximum measured plasma concentration -Tmax
Maximum observed plasma concentration-Cmax
时间窗: Up to 192 hours after the last dose
Maximum observed plasma concentration-Cmax
The main PK parameters Half-life -t1/2
时间窗: Up to 192 hours after the last dose
The main PK parameters Half-life -t1/2
The main PK parameters#Area under the plasma concentration versus time curve-AUC
时间窗: Up to 192 hours after the last dose
The main PK parameters#Area under the plasma concentration versus time curve-AUC
The main PK parameters-CL/F (apparent clearance)
时间窗: Up to 192 hours after the last dose
The main PK parameters-CL/F (apparent clearance)
The main PK parameters-Vz/F (apparent volume of distribution)
时间窗: Up to 192 hours after the last dose
The main PK parameters-Vz/F (apparent volume of distribution)
次要结局
- Incidence of adverse events(Up to Day9)