Kidney function may change how this drug works
NCT ID NCT07694869
First seen Jul 10, 2026 · Last updated Jul 10, 2026
Summary
This Phase 1 trial studies how the drug ammoxetine hydrochloride is processed in people with moderate kidney impairment compared to those with normal kidney function. Sixteen adults receive the drug daily for six days, and researchers measure drug levels in blood and urine. The goal is to understand if kidney problems affect drug exposure and safety, which could guide future dosing recommendations.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ammoxetine hydrochloride
- What this could lead to
- If successful, this study could help determine safe dosing of ammoxetine for people with moderate kidney problems.
- What could go wrong
- This is a very early Phase 1 trial with only 16 participants, so results may not apply broadly. The drug may cause side effects or behave differently than expected.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Inclusion criteria for participants with abnormal liver function (all 7 criteria must be met): 1. Adults aged 18 \~ 75 years (inclusive), regardless of gender 2. Body weight ≥ 45.0 kg (female) or ≥ 50.0 kg (male), body mass index (BMI) in the range of 19 \~ 32 kg/m2 (inclusive); 3. 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 and other examination must be deemed suitable for participation in this study by the investigator; 4. Participants and their partners must use effective contraception (such as condoms or an intrauterine device) 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. 5. Participants who voluntarily sign the informed consent form and agree to cooperate in completing the trial according to the protocol. Exclusion Criteria: Participants meeting any of the following criteria will be excluded from this trial: All participants: 1. Individuals with a history of allergies (allergic to two or more drugs, foods, or pollens); 2. Individuals with major psychiatric disorders, neurological disorders, or other systemic diseases that the investigator deems may affect trial results; 3. Participants who have had a severe infection or trauma within 4 weeks prior to screening, or who have undergone surgery (e.g., gastrectomy) that may affect drug absorption, distribution, metabolism, or excretion, or who are scheduled for surgery or hospitalization for other reasons during the trial period; 4. Participants who have experienced any of the following cardiovascular or cerebrovascular events within 6 months prior to screening: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure (NYHA Class II-IV), a history of clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, or left ventricular dysfunction; transient ischemic attack or cerebrovascular accident (e.g., stroke);history of coronary artery bypass grafting or coronary stenting, or other cardiovascular diseases, and who are deemed unsuitable for participation in this clinical trial by the investigator; 5. Participants who have participated in other drug clinical trials within 3 months prior to screening (as determined by the date of administration); 6. Smokers or heavy drinkers (consumption of 14 units of alcohol per week within 4 weeks prior to screening: 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; 7. Individuals who have donated or lost more than 200 mL of blood within 8 weeks prior to screening; 8. Individuals with a positive breathalyzer test for alcohol or a positive urine test for drug abuse during the screening period; 9. 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; 10. Participants who used strong or moderate inhibitors of liver enzymes (CYP2D6) within 4 weeks prior to screening; 11. Pregnant or breastfeeding women, or female participants who test positive for pregnancy during the screening period; 12. Participants with QTcF on a 12-lead ECG exceeding the upper limit of normal (\>450 ms for males or \>470 ms for females), or those with ECG findings deemed clinically significant by the study physician, history of arrhythmia, syncope related to arrhythmia, or those using of a cardiac pacemaker or other cardiac-related conditions. Note: Conditions include but are not limited to: heart failure; hypokalemia; atrial fibrillation, atrial flutter, atrial premature beats, ventricular premature beats, non-sustained or sustained ventricular tachycardia; bradycardia or sick sinus syndrome; personal or family history of any cardiac conduction abnormalities; personal or family history of long QT syndrome (LQTS); or family history of sudden death; 13. 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); 14. Individuals with a history of dysphagia or any gastrointestinal disease affecting drug absorption; 15. Patients with concurrent viral infections (anti-HCV positive, anti-HIV positive, HBsAg positive) or concurrent syphilis infection; 16. Participants with CYP2D6 poor metabolizer; 17. Participants deemed by the investigator to be unsuitable for this clinical trial for other reasons. Participants with renal impairment: 18. Participants who have undergone a kidney transplant or who require hemodialysis during the study; 19. Participants with urinary tract obstruction or difficulty urinating, urinary incontinence, or anuria; 20. Participants with acute diseases affecting any organ other than the condition causing renal impairment, or those with chronic diseases that may affect the pharmacokinetics of the study drug (e.g., hepatic impairment), who are deemed unsuitable for this trial by the investigator; 21. Participants with coagulation abnormalities (INR \> 1.5 or prothrombin time (PT) \> ULN + 4 seconds or APTT \> 1.5 × ULN), or a history of clinically significant bleeding within the 3 months prior to screening, or a clear predisposition to bleeding, such as gastrointestinal bleeding or hemorrhagic gastric ulcers, or current treatment with thrombolytic or anticoagulant therapy; 22. Participants with systolic blood pressure \>160 mmHg and diastolic blood pressure \>100 mmHg; pulse rate \>100 bpm, during the time of screening; 23. Patients with acute hepatitis, chronic liver disease, or levels of ALT, AST, or GGT exceeding twice the upper limit of normal (ULN), or total bilirubin exceeding 1.5 times the ULN; 24. At screening, patients with gallbladder disease that is determined by the investigator to affect bile excretion; 25. Patients with a history of malignancy, psychiatric disorders, anxiety, or epilepsy; Participants with normal renal function: 26. Participants who have used any prescription drugs, over-the-counter medications, or traditional Chinese medicine (herbal medicines, proprietary Chinese medicines) within 2 weeks prior to screening.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Anhui Medical University
RECRUITINGHefei, Anhui, 230022, China
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