[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatic-impairment-and-healthy-female\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatic-impairment-and-healthy-female":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100635351","phase-1-pharmacokinetics-of-vc005-tablets-in-subjects-with-hepatic-impairment-and-normal-hepatic-function-100635351",false,"NCT07551557","Pharmacokinetics of VC005 Tablets in Subjects With Hepatic Impairment and Normal Hepatic Function","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form prior to the trial, fully understand the trial content, procedures, and possible adverse reactions, and be able to complete the study in accordance with the protocol requirements;\n2. Participants (including their partners) are willing to have no pregnancy plan from screening until 3 months after the last study drug administration and voluntarily take effective contraceptive measures; and have no plans to donate sperm or eggs;\n3. Male and female participants aged 18 to 79 years (inclusive);\n4. Male participants weighing no less than 50.0 kg, female participants weighing no less than 45.0 kg. Body mass index (BMI) between 18 and 32 kg\u002Fm² (inclusive).\n\nExclusion Criteria:\n\n1. History of allergies, including to drugs, food, dust mites, etc., known allergy to the study drug or any of its components;\n2. History of drug abuse, drug addiction and\u002For alcohol abuse (consumption of 14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine); positive results in drug abuse screening and alcohol screening;\n3. Blood donation or significant blood loss (\\> 400 mL) within 3 months prior to screening; or plan to donate blood during the trial; or use of albumin within 14 days before the first dose of the study drug;\n4. Average daily smoking of more than 5 cigarettes within 3 months prior to screening; or inability to stop using any tobacco products during the trial;\n5. History of recurrent herpes zoster, disseminated herpes zoster, or disseminated herpes simplex;\n6. Known active bacterial, viral, fungal, parasitic infection or other infection, or any infectious event requiring antibiotic treatment or hospitalization (within 4 weeks prior to screening), or any acute infection within 2 weeks of baseline;\n7. History of dysphagia or, within 6 months prior to screening, any gastrointestinal conditions affecting drug absorption or excretion (e.g., reflux esophagitis, peptic ulcer, chronic diarrhea, chronic constipation), history of renal disease (confirmed renal disease regardless of cure; if only laboratory abnormalities such as elevated creatinine, hematuria, etc., to be assessed by the investigator), and history of surgery (e.g., gastrointestinal surgery and other major surgeries).",true,"ALL","18 Years","79 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study is a Phase I, single-dose, open-label trial designed to evaluate the pharmacokinetics and safety of a single oral dose of 25 mg VC005 tablets in participants with mild and moderate hepatic impairment compared to participants with normal hepatic function.",[27],"Hepatic Impairment and Healthy Female","NOT_YET_RECRUITING","2026-04-20",{"date":31,"type":32},"2026-04-27","ACTUAL",{"date":34,"type":21},"2026-04-30",{"date":36,"type":21},"2026-10-30",{"name":38,"class":39},"Jiangsu vcare pharmaceutical technology co., LTD","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":15,"sex":48,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":58,"leadSponsor":60,"locationsCount":40},"100630716","phase-1-gs1-144-in-participants-with-hepatic-impairment-and-healthy-female-100630716","NCT07491289","GS1-144 in Participants With Hepatic Impairment and Healthy Female","Pharmacokinetic Study of GS1-144 Tablets in Female Participants With Hepatic Impairment and Healthy Female Participants","Inclusion Criteria:\n\n* Participants 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* Female participants aged 18-70 years (inclusive) (age-matched between the normal hepatic function group and the hepatic impairment groups, mean ±10 years).\n* Females of childbearing potential who are willing to use adequate and effective contraception from the date of signing the ICF until 1 month after administration of the investigational drug.\n* Body weight ≥ 45.0 kg (body weight matched between the normal hepatic function group and the hepatic impairment groups, mean body weight ±10 kg), with BMI within 18.0-32.0 kg\u002Fm2 (inclusive).\n* For participants with normal hepatic function, findings from physical examination, vital signs, clinical laboratory tests (hematology, blood chemistry, urinalysis, coagulation tests, thyroid function test \\[FT3, FT4, and TSH\\], and parathyroid hormone), Chest x-ray (PA), abdominal ultrasound examinations, etc., are normal or abnormal without clinical significance.\n* For participants with hepatic impairment, the following inclusion criteria must also be met to be eligible for this study:\n\n  1. Hepatic impairment caused by hepatitis B, hepatitis C, autoimmune hepatitis, nonalcoholic fatty liver disease, alcoholic liver disease, etc., with Child-Pugh classification assessed as Class A\u002Fmild (Child-Pugh score: 5-6) or Class B\u002Fmoderate (Child-Pugh score: 7-9)\n  2. A stable medication regimen for the treatment of hepatic impairment, complications, and\u002For other concomitant diseases for at least 14 days prior to screening, with no need for modification (e.g., medication type, dose, or dosing frequency); or not receiving medication.\n  3. Clinical laboratory tests: absolute neutrophil count (ANC) ≥ 1.0 × 109\u002FL (1,000\u002Fmm3), platelets (PLT) ≥ 35.0 × 109\u002FL (35,000\u002Fmm3), hemoglobin (HGB) ≥ 8.0 g\u002FdL (80 g\u002FL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal (ULN), creatinine clearance (CLcr, calculated using the Cockcroft-Gault formula) ≥ 60 mL\u002Fmin.\n  4. Systolic blood pressure 90-159 mmHg (Inclusive), diastolic blood pressure 60-99 mmHg (inclusive), and pulse rate 50-100 beats per minute (bpm, inclusive).\n\nExclusion Criteria:\n\n* Allergic constitution (e.g., allergy to more than two drugs or foods), or a history of allergy to the investigational drug or any excipients thereof.\n* Use of tobacco-containing products, nicotine, or nicotine-containing products (e.g., e-cigarettes) within 1 month prior to screening, or unwillingness to stop smoking during the study.\n* Alcohol abuse within 3 months prior to screening (weekly consumption ≥ 14 units of alcohol: 1 unit = 360 mL of beer, or 45 mL of spirits with an alcohol content of 40%, or 150 mL of wine), or unwillingness to stop drinking during the study.\n* Blood loss or donation of ≥ 450 mL of whole blood or plasma within 3 months prior to screening, or receipt of any transfusion of blood or blood products within 60 days.\n* Use of CYP1A2 inducers or CYP1A2 inhibitors within 1 month or within 5 half-lives prior to screening (whichever is longer), and throughout the study (except stable concomitant medications for participants with hepatic impairment).\n* Use of any of the following drugs within 1 month or within 5 half-lives prior to screening (whichever is longer) (including vitamins, hormonal contraceptives, hormone replacement therapy \\[HRT\\], and traditional Chinese medicines, herbal medicines, and Chinese patent medicines \\[e.g., St. John's wort\\]), except for occasional use of acetaminophen (≤ 2 g\u002Fday), topical dermatologic medications (including corticosteroids), and stable concomitant medications for participants with hepatic impairment.\n* Clinically significant abnormal 12-lead ECG findings \\[e.g., tachycardia\u002Fbradycardia requiring drug treatment, second- to third-degree atrioventricular block, or QTcF \\> 470 ms (corrected by Fridericia's formula), or other clinically significant abnormalities\\], and deemed by the investigator as unsuitable for participation.\n* Participation in any clinical study within 3 months or within 5 half-lives prior to screening (whichever is longer) (except those who did not receive treatment).\n* Severe infection, trauma, gastrointestinal surgery, portosystemic shunt, or other major surgeries within 4 weeks prior to screening.\n* Pregnancy, lactation, or a positive serum pregnancy test.\n* Consumption of excessive amounts of tea, coffee, or caffeinated beverages (≥8 cups per day; 1 cup = 250 mL) within 3 months prior to screening; or intake of any food or beverage containing caffeine or xanthine, or that may produce caffeine or xanthine metabolites after ingestion (e.g., coffee, tea, chocolate, cola) within 1 day prior to dosing.\n* Positive urine drug screening (including morphine, methamphetamine, ketamine, 3,4-methylenedioxymethamphetamine \\[MDMA\\], tetrahydrocannabinolic acid, or cocaine). Positive alcohol breath test.\n* Any other condition deemed by the investigator to make the participant unsuitable for participation in this study.\n* Participants with normal hepatic function with a history or current serious disease of the gastrointestinal, respiratory, renal, neurologic, hematologic, endocrine, immune, psychiatric, or cardio-cerebrovascular systems.\n* Participants with normal hepatic function who test positive for any of the following: hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), or TP Ab.\n* participants with hepatic impairment with History of liver transplantation.\n* participants with hepatic impairmen with liver failure or drug-induced liver injury, or with hepatic encephalopathy, hepatocellular carcinoma (except BCLC stage 0), esophageal and gastric variceal rupture bleeding, or other cirrhosis-related complications deemed by the investigator as unsuitable.\n* participants with hepatic impairmen in addition to the primary liver disease, a history or current serious disease of the gastrointestinal, respiratory, renal, neurologic, hematologic, endocrine, immune, psychiatric, cardiovascular, or cerebrovascular systems, or clinically significant laboratory or other test abnormalities that, in the opinion of the investigator, would make them unsuitable for participation.\n* participants with hepatic impairmen with positive HIV antigen\u002Fantibody screening; if TP Ab is positive, an additional RPR test is required; if the RPR is also positive, the participant must be excluded.","FEMALE","70 Years",{"count":20,"type":21},[24],"GS1-144 in Participants with Hepatic Impairment and Healthy Female",[27],"2026-03-18",{"date":56,"type":32},"2026-03-24",{"date":29,"type":21},{"date":59,"type":21},"2027-06-30",{"name":61,"class":39},"Changchun GeneScience Pharmaceutical Co., Ltd."]