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Tests treatment safety and results for Healthy Participants
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, Moderate Hepatic Impairment, and Normal Liver Function
ClinicalTrials.gov ID: NCT07694843
What this study is testing
What is ammoxetine hydrochloride enteric-coated tablets?
ammoxetine hydrochloride enteric-coated tablets is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for healthy participants.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Participants and their partners must use effective contraception (e.g., condoms, inert intrauterine devices, etc.) from 2 weeks prior to screening...
You likely can't join 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...
- Individuals with orthostatic hypotension (a decrease in systolic blood pressure of 20 mmHg or diastolic blood pressure of 10 mmHg upon standing...
- Participants with a 12-lead ECG QTcF\>470 ms, or those with abnormal ECG findings that the study physician determines may influence the study...
- 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...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- Participants who voluntarily sign the informed consent form and agree to cooperate in completing the trial according to the protocol. 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...
- 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...
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.