[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"participants-with-moderate-hepatic-impairment\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:participants-with-moderate-hepatic-impairment":30},{"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":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100646174","phase-1-a-phase-i-clinical-trial-to-evaluate-the-pharmacokinetic-and-safety-of-ammoxetine-hydrochloride-enteric-coated-tablets-in-participants-with-mild-hepatic-impairment-moderate-hepatic-impairment-and-normal-liver-function-100646174",false,"NCT07694843","A Phase I Clinical Trial to Evaluate the Pharmacokinetic and Safety of Ammoxetine Hydrochloride Enteric-Coated Tablets in Participants With Mild Hepatic Impairment, Moderate Hepatic Impairment, and Normal Liver Function","A Phase I Clinical Trial to Evaluate the Pharmacokinetic and Safety of Ammoxetine Hydrochloride Enteric-Coated Tablets in Participants With Mild Hepatic Impairment (Child-Pugh Class A), Moderate Hepatic Impairment (Child-Pugh Class B), and Normal Liver Function","Inclusion Criteria:\n\nInclusion criteria for participants with abnormal liver function (all 7 criteria must be met):\n\n1. Adults aged 18 \\~ 75 years (inclusive), regardless of gender\n2. Body weight ≥ 45.0 kg (female) or ≥ 50.0 kg (male), body mass index (BMI) in the range of 19 \\~ 32 kg\u002Fm2 (inclusive);\n3. Participants whose medical history, vital signs, physical examination, laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function, infectious disease screening, and other relevant tests), Chest X-ray, abdominal color Doppler ultrasound, electroencephalogram (EEG), alpha-fetoprotein (AFP), plasma ammonia, abnormal prothrombin, and other examination must be deemed suitable for participation in this study by the investigator;\n4. Participants and their partners must use effective contraception (e.g., condoms, inert intrauterine devices, etc.) from 2 weeks prior to screening until 6 months after the end of the study, unless they have already undergone permanent sterilization procedures, such as bilateral tubal ligation or vasectomy; furthermore, they must not donate sperm or eggs.\n5. Participants must have not taken any medications within 2 weeks prior to screening, or must have been on a stable medication regimen for at least 4 weeks for the treatment of liver impairment and\u002For other comorbidities;\n6. Participants who have mild or moderate hepatic impairment according to the Child-Pugh classification, resulting from chronic hepatic insufficiency or cirrhosis caused by a history of primary liver disease (e.g., viral hepatitis, alcoholic liver disease, autoimmune hepatitis, etc.), with the investigator determining that the patients liver function would remain stable for ≥1 month based on clinical presentation;\n7. Participants who voluntarily sign the informed consent form and agree to cooperate in completing the trial according to the protocol.\n\nInclusion criteria for participants with normal liver function (all 6 criteria must be met)：\n\n1. Adults aged 18 \\~ 75 years (inclusive), regardless of gender(matched for age and gender with the hepatic impairment group);\n2. Body weight ≥ 45.0 kg (female) or ≥ 50.0 kg (male), body mass index (BMI) in the range of 19 \\~ 32 kg\u002Fm2 (inclusive);\n3. Participants whose medical history, vital signs, physical examination, laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function, infectious disease screening, and other relevant tests), Chest X-ray, abdominal color Doppler ultrasound, and other examination must be deemed suitable for participation in this study by the investigator;\n4. Participants and their partners must use effective contraception (e.g., condoms, inert intrauterine devices, etc.) from 2 weeks prior to screening until 6 months after the end of the study, unless they have already undergone permanent sterilization procedures, such as bilateral tubal ligation or vasectomy; furthermore, they must not donate sperm or eggs.\n5. Participants must have not taken any medications within 2 weeks prior to screening, or must have been on a stable medication regimen for at least 4 weeks for the treatment of other comorbidities;\n6. Participants who voluntarily sign the informed consent form and agree to cooperate in completing the trial according to the protocol.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded from this trial:\n\n1. Individuals with a history of allergies (allergic to two or more drugs, foods, or pollens);\n2. Individuals with major psychiatric disorders, renal disease, neurological disorders, or other systemic diseases that the investigator deems may affect trial results;\n3. Individuals with orthostatic hypotension (a decrease in systolic blood pressure of 20 mmHg or diastolic blood pressure of 10 mmHg upon standing compared to the supine position);\n4. Participants with a 12-lead ECG QTcF\\>470 ms, or those with abnormal ECG findings that the study physician determines may influence the study results, or those with a history of severe arrhythmias, arrhythmia-related syncope, use of a cardiac pacemaker, or other cardiac-related conditions. Conditions include but are not limited to: heart failure; non-sustained or sustained ventricular tachycardia; sick sinus syndrome; or a family history of sudden death;\n5. Smokers or heavy drinkers within 4 weeks prior to screening (consuming 14 units of alcohol per week: 1 unit = 285 mL of beer, 25 mL of spirits, or 150 mL of wine; smoking ≥5 cigarettes per day) or those with a history of substance or drug abuse within the past year;\n6. Individuals with a history of dysphagia or any gastrointestinal disease affecting drug absorption;\n7. Participants with CYP2D6 poor metabolizer;\n8. Individuals with a positive breathalyzer test for alcohol or a positive urine test for drug abuse during the screening period;\n9. Individuals who have donated or lost more than 200 mL of blood within 8 weeks prior to screening;\n10. Participants who have participated in other drug clinical trials within 3 months prior to screening (as determined by the date of administration);\n11. Individuals who habitually consumed excessive amounts of caffeinated beverages or foods within 4 weeks prior to screening. Examples include coffee, tea, chocolate, cola, and Red Bull (daily caffeine intake should not exceed 6 units).1 caffeine unit = 1 cup of coffee (177.4 mL) = 2 cans of cola (354.9 mL) = 1 cup of tea (354.9 mL) = 1\u002F2 cup of energy drink = 85 g of chocolate;\n12. Participants who used strong or moderate inhibitors of liver enzymes (CYP2D6) within 4 weeks prior to screening;\n13. Individuals who have consumed dragon fruit, mango, pomelo, grapefruit, lime, star fruit, pomegranate, or foods or beverages prepared from these fruits within 7 days prior to screening;\n14. Pregnant or breastfeeding women, or female participants who test positive for pregnancy during the screening period;\n15. Individuals with estimated glomerular filtration rate (eGFR) \\\u003C 75 mL\u002Fmin\u002F1.73 m²calculated using the 2021 CKD-EPI formula based on serum creatinine levels during the screening period;\n16. Participants with uncontrolled bacterial, viral, parasitic, or fungal infections requiring treatment at screening (excluding hepatitis B), or a history of severe active infection within 1 month prior to screening;\n17. Participants deemed by the investigator to be unsuitable for this clinical trial for other reasons.\n\n    Additional exclusion criteria for participants with hepatic impairment (exclusion if any one criterion is met):\n18. Participants with clinically significant abnormalities in infectious disease screening as determined by the investigator (e.g., patients with active viral hepatitis such as hepatitis B or C) ;\n19. Participants who have received albumin within 14 days prior to screening;\n20. Participants with alpha-fetoprotein (AFP) \\> 40 ng\u002FmL; or hemoglobin (Hb) ≤ 70 g\u002FL; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 5 times the upper limit of normal (ULN); or total bilirubin ≥ 5 times the ULN; or platelet count ≤ 30 × 109\u002FL;\n21. Patients with drug-induced liver injury; within 2 years of liver cancer surgery; history of liver transplantation; acute liver dysfunction due to any cause; patients with diseases affecting bile excretion, such as biliary cirrhosis, biliary obstruction, or cholestatic liver disease; patients with a history of portal-systemic shunt surgery, including transjugular intrahepatic portosystemic shunt (TIPS);\n22. Patients with a history of any serious disease other than the primary liver disease itself, or a medical history and\u002For clinically significant abnormal laboratory findings that the investigator believes may affect the trial results, including but not limited to a history of diseases of the circulatory, endocrine, nervous, digestive, or urinary systems, or of hematological, immunological, psychiatric, or metabolic disorders;\n23. Participants with severe complications of cirrhosis who also have any of the following conditions: active bleeding from ruptured esophageal or fundic varices; severe or advanced ascites or pleural effusion requiring paracentesis, drainage, and albumin supplementation; participants with hepatorenal syndrome; overt hepatic encephalopathy; liver failure; or other conditions deemed by the investigator to render the participant unsuitable for the study;\n\n    Additional exclusion criteria for participants with normal liver function (exclusion if any one criterion is met):\n24. Participants with a history of liver dysfunction, or physical examination and laboratory tests at screening indicating the presence or possible presence of liver dysfunction;\n25. Participants who have a positive result for hepatitis B surface antigen (HBsAg) or any hepatitis C virus antibody test.",true,"ALL","18 Years","75 Years",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","Use these resources to provide understandable information about this study to patients, families, and health care providers:This study is a multi-center, non-randomized, open-label, parallel-group, multiple-dose Phase I clinical trial evaluating the pharmacokinetic characteristics of ammoxetine hydrochloride enteric-coated tablets in participants with mild hepatic impairment (Child-Pugh Class A), moderate hepatic impairment (Child-Pugh Class B), and participants with normal liver function who are matched for age, weight, and gender. Participants in all groups receive 20 mg of ammoxetine hydrochloride enteric-coated tablets daily at 1 hour after meals, from day 1 to day 6. Blood samples for pharmacokinetic (PK) analysis, and safety parameters are collected before and after dosing according to the trial protocol.",[28,29,30],"Healthy Participants","Participants With Mild Hepatic Impairment","Participants With Moderate Hepatic Impairment","RECRUITING","2026-07-05",{"date":34,"type":35},"2026-07-10","ACTUAL",{"date":37,"type":35},"2026-03-30",{"date":39,"type":22},"2026-11-30",{"name":41,"class":42},"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","INDUSTRY"]