[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatic-impairment-moderate-or-mild--normal-hepatic-function\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatic-impairment-moderate-or-mild--normal-hepatic-function":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100657878","phase-1-a-study-to-evaluate-the-effect-of-hepatic-impairment-on-the-pharmacokinetics-of-hs-10506-100657878",false,"NCT07844967","A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of HS-10506","HS-10506-114","Inclusion Criteria:\n\nParticipants who sign the ICF prior to the trial, have a full understanding of the trial content, procedures, and possible adverse reactions, and are able to complete the study in accordance with the protocol requirements.\n\n* 18 years of age, male or female. BMI 19.0\\~32.0 kg\u002Fm² and body weight \\>50 kg of male and \\>45 kg of female.\n\nCohort A \\& C (with hepatic impairment):\n\nStable hepatic impairment classified as Child-Pugh Class A (mild) and B (moderate) No clinically significant worsening of hepatic status at least 2 months.\n\nCohort B \\& D (without hepatic impairment):\n\nBMI matched with hepatic impairment, mean ±10% Age matched with hepatic impairment, mean ±3 years Gender matched with hepatic impairment\n\nExclusion Criteria:\n\nAlpha-fetoprotein (AFP) \\> 20 ng\u002FmL at screening. Current or past history of mental disorders or cerebral dysfunction; participants with suicide risk as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS); history of self-harm or suicide attempt within 1 year prior to screening; or participants deemed to be at suicide risk based on the investigator's clinical judgment.\n\nPast or current severe diseases of the nervous system, psychiatric system, digestive system, circulatory system, respiratory system (e.g., abnormal airway anatomical structures, congenital macroglossia, mandibular dysplasia; chronic obstructive pulmonary disease, obstructive sleep apnea syndrome), urinary system or other systemic diseases, which are considered unsuitable for study participation by the investigator.\n\nPast or current active gastrointestinal diseases and symptoms including active gastric ulcer and reflux esophagitis (e.g., heartburn, acid regurgitation), which are deemed unsuitable for enrollment by the investigator.\n\nA history of surgeries that may affect drug absorption, distribution, metabolism and excretion (ADME), and considered unsuitable for enrollment by the investigator.\n\nSusceptibility to allergic reactions, allergic diathesis (e.g., allergy to pollen, two or more drugs or food items), or known hypersensitivity to any ingredients of the investigational product.\n\nParticipation in any other clinical trial and administration of any investigational medicinal products or devices within 3 months prior to screening; or within 7 elimination half-lives of other study drugs at screening, whichever is longer.\n\nUse of strong or moderate CYP3A inhibitors or inducers within 30 days prior to the first dose of investigational product (or 7 times the corresponding elimination half-life, whichever is longer).\n\nUse of any medications that alter gastric pH within 14 days prior to the first dose of investigational product .\n\nHistory of massive blood loss (\\> 400 mL) or blood donation within 3 months prior to screening; or planned blood donation during the study period and within 3 months after study completion.\n\nSignificant changes in dietary or sleeping habits within 4 weeks prior to screening, which are considered unsuitable for study participation by the investigator.\n\nConsumption of grapefruit or grapefruit-containing products within 48 hours prior to the first dose of investigational product.\n\nExcessive intake of tea, coffee or caffeinated beverages within 3 months prior to screening (average daily intake \\> 8 cups; 1 cup = 200 mL).\n\nAverage daily cigarette consumption of more than 5 cigarettes within 3 months prior to screening, or inability to abstain from all tobacco products during the study.\n\nRegular alcohol consumption within 3 months prior to screening (i.e., more than 14 alcohol units per week; 1 unit = 14 g alcohol, equivalent to 360 mL beer, 45 mL 40% alcohol spirit, or 150 mL wine) or inability to abstain from alcoholic beverages during the study.\n\nIntake of any alcohol-containing products within 24 hours prior to investigational product administration, or a positive breath alcohol test result.\n\nHistory of substance abuse or dependence, or illicit drug use within 5 years prior to screening, or positive urine drug screen result.\n\nAdministration of albumin within 14 days prior to the first dose of investigational product.\n\nLactating or pregnant women; or positive serum pregnancy test with clinically significant abnormalities as judged by the investigator.\n\nInability to tolerate venous puncture or indwelling needle blood collection, or fear of needles or blood.\n\nAny other conditions that may prevent the subject from completing the study, or other factors deemed unsuitable for study participation by the investigator.\n\nParticipants with normal hepatic function will be excluded if they meet any of the following criteria:\n\nClinically significant abnormalities identified by the investigator in physical examination, vital signs, electrocardiogram (ECG), abdominal ultrasound, chest X-ray, or clinical laboratory tests.\n\nPositive result for any of the following at screening: hepatitis B surface antigen, anti-hepatitis C virus antibody, anti-Treponema pallidum antibody, human immunodeficiency virus (HIV) antigen\u002Fantibody.\n\nProlonged QT interval on 12-lead ECG at screening (QTcF \\> 450 ms for males, QTcF \\> 470 ms for females).\n\nUse of any prescription drugs, over-the-counter drugs, traditional Chinese herbal medicines or dietary supplements within 14 days prior to the first dose of investigational product (excluding topically administered agents with local effects); or within 7 elimination half-lives of any prior medication, whichever is longer.\n\nHistory of hepatic injury.\n\nParticipants with hepatic impairment will be excluded if they meet any of the following criteria:\n\nPositive HIV antigen\u002Fantibody or positive anti-Treponema pallidum antibody. Positive hepatitis B surface antigen with hepatitis B viral DNA above the upper limit of detection; or positive anti-hepatitis C virus antibody with hepatitis C viral RNA above the upper limit of detection.\n\nFurther exclusion criteria apply.",true,"ALL","18 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Moderate Hepatic Impairment Study Phase\n\nThis phase employs a multicenter, open-label, parallel-group, single-dose study design.Two cohorts are established in this phase:\n\nCohort A: Subjects with moderate hepatic impairment Cohort B: Subjects with normal hepatic function A total of 8 subjects of either gender will be enrolled in each cohort. Enrolled subjects will be admitted to the Phase I clinical research unit on Day -1 and fasted for at least 10 hours. On Day 1, subjects will receive a single oral dose of 20 mg HS-10506 tablets in a fasted state. Water intake is prohibited within 1 hour before and after dosing (excluding water used for drug administration). Food intake is restricted for at least 4 hours post-dose. All study medications will be administered with approximately 240 mL of water.\n\nSubjects with normal hepatic function (Cohort B) serve as the matched control group for subjects with moderate hepatic impairment (Cohort A), and shall meet the following matching criteria:\n\nThe mean body mass index (BMI) of Cohort B is within ±10% of the mean BMI of Cohort A.\n\nThe mean age of Cohort B is within ±3 years of the mean age of Cohort A. The number of male and female subjects in Cohort B is consistent with that in Cohort A for each gender.\n\nMild Hepatic Impairment Study Phase Based on the results of the moderate hepatic impairment study phase, the sponsor and principal investigator will jointly determine whether to conduct a study to evaluate the effect of mild hepatic impairment. The phase design and procedures of the mild hepatic impairment are consistent with those of the moderate hepatic impairment.\n\nSubjects with normal hepatic function (Cohort D) serve as the matched control group for subjects with mild hepatic impairment (Cohort C), and shall meet the following matching criteria:\n\nThe mean BMI of Cohort D is within ±10% of the mean BMI of Cohort C. The mean age of Cohort D is within ±3 years of the mean age of Cohort C. The number of male and female subjects in Cohort D is consistent with that in Cohort C for each gender.",[27],"Hepatic Impairment (Moderate or Mild) & Normal Hepatic Function",[29,30,31],"HS-10506","Hepatic Impairment","Pharmacokinetics","RECRUITING","2026-09-22",{"date":35,"type":36},"2026-09-28","ACTUAL",{"date":38,"type":36},"2026-06-01",{"date":40,"type":21},"2028-06-01",{"name":42,"class":43},"Jiangsu Hansoh Pharmaceutical Co., Ltd.","INDUSTRY"]