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Breakfast or not? study tests Food's impact on new pill

NCT ID NCT07508462

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 1 trial tested how a high-fat or low-fat meal changes the way the body absorbs ammoxetine, a potential antidepressant. Eighteen healthy adults each took a single 60 mg dose under three different meal conditions. The goal was to see if food affects drug levels in the blood, 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 whether ammoxetine should be taken with or without food for best absorption.
What could go wrong
This is a small, early-stage trial in healthy people, not patients. Results may not predict real-world effects or safety in those with depression.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

18 people

The number who actually took part.

Started

May 2024

Finished

Aug 2024

Lead sponsor

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

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: 1. Age: 18-45 years (inclusive), both male and female subjects; 2. Body weight ≥ 45.0 kg (female) or 50.0 kg (male), with body mass index (BMI) between 19.0 kg/m² and 28.0 kg/m² (inclusive); 3. Results of medical history, vital signs, physical examination, laboratory tests (including complete blood count, blood biochemistry, urinalysis, coagulation function, and other relevant tests), and chest X-ray examination are normal or abnormal but without clinical significance; 4. Subjects with corrected QT interval using Fridericia's formula exceeding the upper limit of normal (male ≥450 ms or female ≥460 ms), or with abnormal electrocardiogram findings considered clinically significant by the study physician, or with a history of arrhythmias or syncope associated with arrhythmias, or using a pacemaker. 5. Voluntarily sign the informed consent form and be willing to comply with the protocol to complete the study. Exclusion Criteria: 1. Subjects with a history of allergies (allergic to two or more types of drugs, foods, or pollen); 2. Subjects suffering from psychiatric disorders, hepatic or renal diseases, gastrointestinal diseases, neurological diseases, or other systemic diseases; 3. Subjects with orthostatic hypotension; 4. Subjects with a 12-lead ECG QTcF interval exceeding the upper limit of normal (male ≥450 ms or female ≥460 ms), or with abnormal ECG findings considered clinically significant by the study physician, or with a history of arrhythmias or syncope associated with arrhythmias, or using a pacemaker. Note: Diseases include, but are not limited to: heart failure; hypokalemia; atrial fibrillation, atrial flutter, premature atrial contractions, premature ventricular contractions, 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; 5. Subjects with a history of smoking or alcohol abuse (consumption of 14 units of alcohol per week within the 4 weeks prior to screening: 1 unit = 285 mL beer, or 25 mL spirits, or 150 mL wine; daily smoking ≥ 5 cigarettes) or other substance or drug abuse within the past year; 6. Subjects with a positive alcohol breath test or positive urine drug screen during the screening period; 7. Subjects who have donated or lost more than 400 mL of blood within the 8 weeks prior to screening; 8. Subjects who have participated in other drug clinical trials within the 3 months prior to screening; 9. Subjects who habitually consume excessive amounts of caffeinated beverages or foods within the 4 weeks prior to screening, such as coffee, tea, chocolate, cola, or Red Bull (daily caffeine intake not exceeding 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 chocolate; 10. Subjects who have used medications that alter the activity of liver enzymes (Cytochrome P450 2C19 and Cytochrome P450 3A4) within the 4 weeks prior to screening, such as dexamethasone, ketoconazole, rifampicin, or omeprazole; 11. Subjects who have consumed dragon fruit, mango, shaddock, grapefruit, lime, star fruit, pomegranate, or any foods or beverages prepared from these fruits within the 7 days prior to screening; 12. Subjects who have used prescription drugs, over-the-counter medications (except for occasional use of acetaminophen and nasal sprays), herbal remedies, vitamins, or minerals within the 2 weeks prior to screening, or for whom the washout period of prior medications (based on the longest half-life) is less than 5 half-lives before screening; 13. Subjects using any psychiatric medications or psychoactive substances; 14. Pregnant or lactating women, or female subjects with a positive pregnancy test during the screening period; 15. Subjects considered by the investigator to have any factors that make them unsuitable for participation in this trial.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • The Fourth Hospital of Hebei Medical University, Hebei Tumor Hospital

    Shijiazhuang, Hebei, 050035, China

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