Healthy ParticipantsPhase 1NCT07694843
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 1 study testing ammoxetine hydrochloride enteric-coated tablets in people with Healthy Participants and Participants With Mild Hepatic Impairment, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Participants With Mild Hepatic Impairment, Participants With Moderate Hepatic Impairment
- What is being tested?
- ammoxetine hydrochloride enteric-coated tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2026to 30 Nov 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria for participants with abnormal liver function (all 7 criteria must be met):
- Adults aged 18 ~ 75 years (inclusive), regardless of gender
- Body weight ≥ 45.0 kg (female) or ≥ 50.0 kg (male), body mass index (BMI) in the range of 19 ~ 32 kg/m2 (inclusive);
- 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;
- 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.
- 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/or other comorbidities;
Show all 15Show fewer
- 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;
- Participants who voluntarily sign the informed consent form and agree to cooperate in completing the trial according to the protocol.
- Inclusion criteria for participants with normal liver function (all 6 criteria must be met)：
- Adults aged 18 ~ 75 years (inclusive), regardless of gender(matched for age and gender with the hepatic impairment group);
- Body weight ≥ 45.0 kg (female) or ≥ 50.0 kg (male), body mass index (BMI) in the range of 19 ~ 32 kg/m2 (inclusive);
- 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;
- 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.
- 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;
- Participants who voluntarily sign the informed consent form and agree to cooperate in completing the trial according to the protocol.
Who cannot join
- Participants meeting any of the following criteria will be excluded from this trial:
- Individuals with a history of allergies (allergic to two or more drugs, foods, or pollens);
- Individuals with major psychiatric disorders, renal disease, neurological disorders, or other systemic diseases that the investigator deems may affect trial results;
- 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);
- 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;
- 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;
Show all 28Show fewer
- Individuals with a history of dysphagia or any gastrointestinal disease affecting drug absorption;
- Participants with CYP2D6 poor metabolizer;
- Individuals with a positive breathalyzer test for alcohol or a positive urine test for drug abuse during the screening period;
- Individuals who have donated or lost more than 200 mL of blood within 8 weeks prior to screening;
- Participants who have participated in other drug clinical trials within 3 months prior to screening (as determined by the date of administration);
- 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) = 1/2 cup of energy drink = 85 g of chocolate;
- Participants who used strong or moderate inhibitors of liver enzymes (CYP2D6) within 4 weeks prior to screening;
- 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;
- Pregnant or breastfeeding women, or female participants who test positive for pregnancy during the screening period;
- Individuals with estimated glomerular filtration rate (eGFR) < 75 mL/min/1.73 m²calculated using the 2021 CKD-EPI formula based on serum creatinine levels during the screening period;
- 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;
- Participants deemed by the investigator to be unsuitable for this clinical trial for other reasons.
- Additional exclusion criteria for participants with hepatic impairment (exclusion if any one criterion is met):
- 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) ;
- Participants who have received albumin within 14 days prior to screening;
- Participants with alpha-fetoprotein (AFP) > 40 ng/mL; or hemoglobin (Hb) ≤ 70 g/L; 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/L;
- 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);
- Patients with a history of any serious disease other than the primary liver disease itself, or a medical history and/or 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;
- 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;
- Additional exclusion criteria for participants with normal liver function (exclusion if any one criterion is met):
- Participants with a history of liver dysfunction, or physical examination and laboratory tests at screening indicating the presence or possible presence of liver dysfunction;
- Participants who have a positive result for hepatitis B surface antigen (HBsAg) or any hepatitis C virus antibody test.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Miu Liyan, Ph.D, 0512-67972858, miaolysuzhou@163.com
About this study
Official title: 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
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.
Read the detailed description
Avoid duplicating information that will be entered or uploaded elsewhere in the record.
- Conditions
- Healthy Participants, Participants With Mild Hepatic Impairment, Participants With Moderate Hepatic Impairment
- Being tested
- ammoxetine hydrochloride enteric-coated tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ammoxetine hydrochloride enteric-coated tabletsDrug
Oral administration; 20 mg
| Study group | Role | What they receive |
|---|---|---|
| Mild hepatic impairment Group | Experimental | Not described Receives: Drug: ammoxetine hydrochloride enteric-coated tablets |
| Moderate hepatic impairment Group | Experimental | Not described Receives: Drug: ammoxetine hydrochloride enteric-coated tablets |
| Normal hepatic function Group | Experimental | Not described Receives: Drug: ammoxetine hydrochloride enteric-coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration vs. time curve for one dosing interval at steady-state (AUCtau,ss)
Measured: Within 120 hours after the last dose
Maximum concentration observed during dosing interval at steady-state (Cmax,ss)
Measured: Within 120 hours after the last dose
Secondary outcomes (7)
The incidence of adverse events (AEs)
Measured: Up to 120 hours after the last dose
Minimum concentration observed during dosing interval at steady-state (Cmin,ss)
Measured: Up to 120 hours after the last dose
Half-Life (t1/2)
Measured: Up to 120 hours after the last dose
Mean concentration observed during dosing interval at steady-state (Cav,ss)
Measured: Up to 120 hours after the last dose
Plasma Maximum concentration (Cmax)
Measured: Within 24 hours after the first dose
Area under the concentration-time curve up to the last sampling point(AUClast)
Measured: Within 24 hours after the first dose
Accumulation index of AUC(RAUC)
Measured: Within 24 hours after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start30 Mar 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Drug: ammoxetine hydrochloride enteric-coated tablets .
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694843
- Sponsor's protocol ID
- HA1406-012
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No