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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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
Are there results?: Not yet: the study is under way

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;

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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;

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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.

Clinical Trials Information Group officer contact

031169085587

ctr-contact@cspc.cn

China1 site, 1 recruiting

The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Miu Liyan, Ph.D, 0512-67972858, miaolysuzhou@163.com
Recruiting

Other trials in China

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 groups in NCT07694843
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.

30 Mar 202630 Nov 2026

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.
More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
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)

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

Interested in taking part?

Clinical Trials Information Group officer

031169085587

ctr-contact@cspc.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Healthy Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07694843
Acronym / sponsor ID: HA1406-012
Conditions: Healthy Participants, Participants With Mild Hepatic Impairment, Participants With Moderate Hepatic Impairment
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 24 participants (estimated)
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
Study start: 30 Mar 2026 (actual)
Primary completion: 31 Oct 2026 (estimated)
Study completion: 30 Nov 2026 (estimated)
First posted: 10 Jul 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Avoid duplicating information that will be entered or uploaded elsewhere in the record.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3
Model description: Drug: ammoxetine hydrochloride enteric-coated tablets .

Arm	Type	Receives
Mild hepatic impairment Group	Experimental	Drug: ammoxetine hydrochloride enteric-coated tablets
Moderate hepatic impairment Group	Experimental	Drug: ammoxetine hydrochloride enteric-coated tablets
Normal hepatic function Group	Experimental	Drug: ammoxetine hydrochloride enteric-coated tablets

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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.

Key exclusion criteria (28 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ammoxetine hydrochloride enteric-coated tabletsOral administration; 20 mg	Drug	Mild hepatic impairment Group, Moderate hepatic impairment Group, Normal hepatic function Group

Primary outcome

Area under the concentration vs. time curve for one dosing interval at steady-state (AUCtau,ss)
Time frame: Within 120 hours after the last dose
Maximum concentration observed during dosing interval at steady-state (Cmax,ss)
Time frame: Within 120 hours after the last dose

7 secondary outcomes

The incidence of adverse events (AEs)
Time frame: Up to 120 hours after the last dose
Minimum concentration observed during dosing interval at steady-state (Cmin,ss)
Time frame: Up to 120 hours after the last dose
Half-Life (t1/2)
Time frame: Up to 120 hours after the last dose
Mean concentration observed during dosing interval at steady-state (Cav,ss)
Time frame: Up to 120 hours after the last dose
Plasma Maximum concentration (Cmax)
Time frame: Within 24 hours after the first dose
Area under the concentration-time curve up to the last sampling point(AUClast)
Time frame: Within 24 hours after the first dose
Accumulation index of AUC(RAUC)
Time frame: Within 24 hours after the first dose

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Clinical Trials Information Group officer contact

031169085587

ctr-contact@cspc.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Information Group officer (031169085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the concentration vs. time curve for one dosing interval at steady-state (AUCtau,ss) (time frame: Within 120 hours after the last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07694843.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.