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临床试验/NCT07836504
NCT07836504尚未招募1 期

A Pharmacokinetic Study of HS-10504 in Participants With Hepatic Impairment and Normal Hepatic Function.

Jiangsu Hansoh Pharmaceutical Co., Ltd.0 个研究点目标入组 32 人开始时间: 2026年9月30日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
32
主要终点
Evaluation of PK parameters of HS-10504: Cmax
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This is a two-part single-center, open-label, parallel, single-dose pharmacokinetic study of HS-10504 in participants with hepatic impairment and normal hepatic function.

详细描述

In each part, two treatment groups were set up (Group A: participants with moderate hepatic impairment; Group B: participants with normal hepatic function), and 8 participants (both males and females) were enrolled in each group. On Day 1, a single oral dose of 400 mg HS-10504 tablet was administered in the fasting state.

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 —（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •All participants must meet ALL of the following criteria to be eligible for this study:
  • •Provide written informed consent before any study related procedures, have a full understanding of the study, its procedures, and possible adverse events, and express a willingness and ability to comply with the protocol requirements.
  • •Be male or female adults.
  • •Agree to practice highly effective contraception from the time of signing the informed consent form until 6 months after the last dose of study drug (only non pharmacological contraceptive measures are allowed during the study), and refrain from attempting to conceive or donate sperm/eggs during this period.
  • •Participants with normal hepatic function must meet the following criterion to be eligible for this study:
  • •1. Participants in the normal hepatic function group should be matched with those in the hepatic impairment group for body mass index (BMI), age, and sex.
  • •Participants with hepatic impairment must meet the following criteria to be eligible for this study:
  • •Chronic liver injury caused by primary liver disease;
  • •The investigator judges that the participant's hepatic function status is stable based on the participant's clinical symptoms and other available examination results at screening;
  • •Have had a stable medication regimen for the treatment of hepatic impairment, complications, and other concomitant diseases for at least 14 days prior to administration of the investigational product, with no need for dose adjustment; or have not been on any such medication.

排除标准

  • •Participants who meet any of the following criteria will not be enrolled in this study:
  • •Have participated in any other clinical trial and used any investigational drug/device within 3 months prior to screening;
  • •Have a history of surgery within 3 months prior to screening, or have planned surgery during the study period, or have undergone surgery that may affect drug absorption, distribution, metabolism, or excretion;
  • •Have experienced significant blood loss or blood donation within 3 months prior to screening, or blood loss ≥200 mL within 1 month, or have planned blood donation during the study period;
  • •Have used strong or moderate inhibitors or inducers of CYP3A4/5, CYP2C8, and CYP2D6 within 30 days prior to the first dose of the investigational product, or have used albumin within 14 days prior to the first dose;
  • •Have a history of, or currently have, severe diseases of the nervous, psychiatric, digestive, circulatory, respiratory, urinary systems, etc., or have developed a new illness before administration of the investigational product, which is assessed by the investigator as unsuitable for participation in this study;
  • •Have a history of severe allergy, are prone to allergic reactions, or have an allergic constitution, or are known to be allergic to any component of the investigational product;
  • •Have regularly consumed alcohol within 3 months prior to screening or are unable to refrain from alcohol consumption during the study period, or have a positive alcohol breath test at screening;
  • •Have smoked an average of >5 cigarettes per day within 3 months prior to screening, or are unable to refrain from using any tobacco products during the study period;
  • •Have consumed excessive amounts of tea, coffee, and/or caffeinated beverages within 3 months prior to screening;
  • •Have a history of drug abuse, drug dependence, or illicit drug use within 5 years prior to screening, or have a positive drug abuse screening test;
  • •Are lactating women within 1 month prior to screening or during the study period, or have a positive pregnancy test;
  • •Have had unprotected sexual intercourse within 14 days prior to screening;
  • •Have special dietary requirements, are unable to comply with a uniform diet, or have difficulty swallowing;
  • •Are unable to tolerate venipuncture or indwelling needle blood sampling, or have a history of needle phobia or blood phobia;
  • •Are unable to complete the study for other reasons, or are judged by the investigator as unsuitable for participation.
  • •Participants with normal hepatic function who meet any of the following exclusion criteria will be excluded:
  • •History of hepatic impairment;
  • •Clinically significant abnormalities in physical examination, vital signs, 12 lead ECG, or clinical laboratory tests at screening that are judged by the investigator as unsuitable for enrollment;
  • •Use of any prescription drugs, over the counter drugs, herbal medicines, or health supplements within 14 days prior to the first dose of the investigational product, or use of any drug without a washout period of at least 7 half lives.
  • •Participants with hepatic impairment who meet any of the following exclusion criteria will be excluded:
  • •The participant has any of the following conditions that, in the investigator's assessment, makes them unsuitable for participation in this trial: ① history of liver transplantation; ② history of partial hepatectomy; ③ suspected or confirmed hepatocellular carcinoma or other malignancies; ④ hepatic failure; ⑤ bleeding from esophageal and gastric varices within 3 months prior to screening; ⑥ diseases such as biliary cirrhosis or extrahepatic biliary obstruction; ⑦ coexisting overt hepatic encephalopathy, refractory ascites, or hepatorenal syndrome.
  • •Apart from the primary liver disease itself, the participant has a history of or currently has other severe systemic organ diseases or clinically significant laboratory abnormalities that, in the investigator's judgment, make them unsuitable for participation in this trial.

研究组 & 干预措施

Participants with normal hepatic function

Experimental

干预措施: HS-10504 (Drug)

Participants with hepatic impairment

Experimental

干预措施: HS-10504 (Drug)

结局指标

主要结局

Evaluation of PK parameters of HS-10504: Cmax

时间窗: 216 hours after administration of HS-10504

To evaluate the Cmax of HS-10504 in participants with hepatic impairment and normal hepatic function

Evaluation of PK parameters of HS-10504: AUC0-t

时间窗: 216 hours after administration of HS-10504

To evaluate the AUC0-t of HS-10504 in participants with hepatic impairment and normal hepatic function

Evaluation of PK parameters of HS-10504: AUC0-∞

时间窗: 216 hours after administration of HS-10504

To evaluate the AUC0-∞ of HS-10504 in participants with hepatic impairment and normal hepatic function

次要结局

  • Evaluation of PK parameters of HS-10504 and metabolite M6-2: Cmax.(216 hours after administration of HS-10504)
  • Evaluation of PK parameters of HS-10504 and metabolite M6-2: AUC0-t.(216 hours after administration of HS-10504)
  • Evaluation of PK parameters of HS-10504 and metabolite M6-2: AUC0-∞.(216 hours after administration of HS-10504)
  • Evaluation of PK parameters of HS-10504 and metabolite M6-2: Tmax.(216 hours after administration of HS-10504)
  • Evaluation of PK parameters of HS-10504 and metabolite M6-2: t1/2z.(216 hours after administration of HS-10504)
  • Evaluation of PK parameters of HS-10504 and metabolite M6-2: λz.(216 hours after administration of HS-10504)
  • Evaluation of PK parameters of HS-10504 and metabolite M6-2: CL/F.(216 hours after administration of HS-10504)
  • Evaluation of PK parameters of HS-10504 and metabolite M6-2: Vz/F.(216 hours after administration of HS-10504)
  • Evaluation of PK parameters of HS-10504 and metabolite M6-2: MRT0-t.(216 hours after administration of HS-10504)
  • Evaluation of PK parameters of HS-10504 and metabolite M6-2: MRT0-∞(216 hours after administration of HS-10504)
  • Evaluation of PK parameters of HS-10504 and metabolite M6-2: fu.(216 hours after administration of HS-10504)
  • Evaluation of PK parameters of HS-10504 and metabolite M6-2: Cmax,Unbound.(216 hours after administration of HS-10504)
  • Evaluation of PK parameters of HS-10504 and metabolite M6-2: AUC0-t,Unbound.(216 hours after administration of HS-10504)
  • Evaluation of PK parameters of HS-10504 and metabolite M6-2: AUC0-∞,Unbound.(216 hours after administration of HS-10504)
  • Evaluation of PK parameters of HS-10504 and metabolite M6-2:CL/F,Unbound .(216 hours after administration of HS-10504)
  • Adverse events(Up to end of the study, approximately 3 months.)
  • vital signs(blood pressure)(Up to end of the study, approximately 3 month.)
  • vital signs( Pulse)(Up to end of the study, approximately 3 month.)
  • vital signs(body temperature)(Up to end of the study, approximately 3 month.)
  • Number of participants with clinical laboratory tests(complete blood count (CBC))(Up to end of the study, approximately 3 month.)
  • Number of participants with urinalysis(Up to end of the study, approximately 3 month.)
  • Number of participants with abnormal blood chemistry(Up to end of the study, approximately 3 month.)
  • Number of participants with abnormal coagulation tests(Up to end of the study, approximately 3 month.)
  • 12-lead electrocardiogram（ heart rate）(Up to end of the study, approximately 3 month.)
  • 12-lead electrocardiogram（PR）(Up to end of the study, approximately 3 month.)
  • 12-lead electrocardiogram（RR）(Up to end of the study, approximately 3 month.)
  • 12-lead electrocardiogram（QRS duration）(Up to end of the study, approximately 3 month.)
  • 12-lead electrocardiogram（QTcF）(Up to end of the study, approximately 3 month.)
  • Number of participants with abnormal general inspection(Up to end of the study, approximately 3 month.)
  • Number of participants with abnormal head and neck(Up to end of the study, approximately 3 month.)
  • Number of participants with abnormal lymph nodes(Up to end of the study, approximately 3 month.)
  • Number of participants with abnormal chest(Up to end of the study, approximately 3 month.)
  • Number of participants with abnormal abdomen(Up to end of the study, approximately 3 month.)
  • Number of participants with abnormal spine and extremities(Up to end of the study, approximately 3 month.)
  • Number of participants with abnormal neurological examination(Up to end of the study, approximately 3 month.)

研究者

发起方
Jiangsu Hansoh Pharmaceutical Co., Ltd.
申办方类型
Industry
责任方
Sponsor

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