A Pharmacokinetic Study of D-2570 in Participants With Hepatic Impairment and Normal Hepatic Function
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名:Huan Zhou
- 电话号码:+86 0552-3085747
- 邮箱:zhouhuanbest@vip.163.com
学习地点
-
-
Anhui
-
Bengbu、Anhui、中国、233004
- 招聘中
- The First Affiliated Hospital of Bengbu Medical University
-
接触:
- Huan Zhou
- 电话号码:+86 0552-3085747
- 邮箱:zhouhuanbest@vip.163.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:D-2570 Group 1
D-2570 Group 1 |
D-2570 tablet, administered orally as a single dose |
|
实验性的:D-2570 Group 2
D-2570 Group 2 |
D-2570 tablet, administered orally as a single dose |
|
实验性的:D-2570 Group 3
D-2570 Group 3 |
D-2570 tablet, administered orally as a single dose |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The main PK parameters -Time to maximum measured plasma concentration -Tmax Population pharmacokinetic characteristics of D-2570
大体时间:Up to 192 hours after the last dose
|
The main PK parameters -Time to maximum measured plasma concentration -Tmax |
Up to 192 hours after the last dose
|
|
Maximum observed plasma concentration-Cmax
大体时间:Up to 192 hours after the last dose
|
Maximum observed plasma concentration-Cmax |
Up to 192 hours after the last dose
|
|
The main PK parameters Half-life -t1/2
大体时间:Up to 192 hours after the last dose
|
The main PK parameters Half-life -t1/2 |
Up to 192 hours after the last dose
|
|
The main PK parameters#Area under the plasma concentration versus time curve-AUC
大体时间:Up to 192 hours after the last dose
|
The main PK parameters#Area under the plasma concentration versus time curve-AUC |
Up to 192 hours after the last dose
|
|
The main PK parameters-CL/F (apparent clearance)
大体时间:Up to 192 hours after the last dose
|
The main PK parameters-CL/F (apparent clearance) |
Up to 192 hours after the last dose
|
|
The main PK parameters-Vz/F (apparent volume of distribution)
大体时间:Up to 192 hours after the last dose
|
The main PK parameters-Vz/F (apparent volume of distribution) |
Up to 192 hours after the last dose
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of adverse events
大体时间:Up to Day9
|
Incidence of adverse events |
Up to Day9
|
合作者和调查者
调查人员
- 首席研究员:Huan Zhou、The First Affiliated Hospital of Bengbu Medical University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- D2570-106
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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