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

NCT07694843 | Recruiting Phase 1

• 1 other identifier: HA1406-012
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Healthy Participants; Participants With Mild Hepatic Impairment; Participants With Moderate Hepatic Impairment

Outcome Measures

Primary Outcomes (2)

• Area under the concentration vs. time curve for one dosing interval at steady-state (AUCtau,ss)

  Within 120 hours after the last dose

• Maximum concentration observed during dosing interval at steady-state (Cmax,ss)

  Within 120 hours after the last dose

Secondary Outcomes (7)

• The incidence of adverse events (AEs)

  Up to 120 hours after the last dose

• Minimum concentration observed during dosing interval at steady-state (Cmin,ss)

  Up to 120 hours after the last dose

• Half-Life (t1/2)

  Up to 120 hours after the last dose

• Mean concentration observed during dosing interval at steady-state (Cav,ss)

  Up to 120 hours after the last dose

• Plasma Maximum concentration (Cmax)

  Within 24 hours after the first dose

Study Arms (3)

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

Interventions

ammoxetine hydrochloride enteric-coated tablets DRUG

Oral administration; 20 mg

Mild hepatic impairment Group; Moderate hepatic impairment Group; Normal hepatic function Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

031169085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Drug: ammoxetine hydrochloride enteric-coated tablets .

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 10, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-07

Locations

CN (1)