Meal timing matters: new study tests drug absorption after High-Fat breakfast

NCT ID NCT07566572

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Recruiting now This study
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
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 Results may not be published yet.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)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study looks at how a high-fat meal and different drinking conditions change the way a new drug (BGM0504) is processed in the body. It involves 144 healthy Chinese adults aged 18 to 55. The goal is to understand the best way to take the drug for future trials, not to treat any disease.

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

About 144 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Sep 2026

An estimate. End dates often move.

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 55 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: * ○ Between the ages of 18 and 55 years (inclusive) at the time of screening, both male and female; * weight ≥ 50 kg, and body mass index (BMI): 24.0 kg/m² ≤ BMI \< 30 kg/m²(BMI = weight/height²); * (Medical Inquiry) Have a stable body weight (\<5% self-reported change during the previous 12 weeks) before screening. * Participants should be willing to take effective contraceptive measures from the date of signing the informed consent form until 3 months after the last administration, and have no plans for sperm or egg donation. * Participants who were determined to be generally healthy by the investigator based on their past medical history, physical examination, vital signs, laboratory tests and electrocardiogram examinations. Exclusion Criteria: * ● (Medical Inquiry) Individuals with a history of severe drug allergies (especially known or suspected allergies to the components and excipients of BGM0504 tablets) or those with severe specific allergic diseases/diseases history or severe allergic constitution; * (Medical Inquiry) Individuals who have previously suffered from or currently have major diseases in the nervous system, cardiovascular system, digestive system, respiratory system, urinary system, endocrine system, blood system or immune system, and are judged by the investigator to be unsuitable to participate in this trial; * (Examination) Any laboratory test results judged by the investigator as abnormal and of clinical significance; * (Medical Inquiry/Examination) Individuals who previously had obvious gastrointestinal diseases or related symptoms (such as nausea, vomiting, heartburn sensation or diarrhea), affected gastric emptying (such as pyloric stenosis), or had undergone any gastrointestinal surgery (except for intestinal polyp resection and appendectomy), or had acute diarrhea, constipation within the 7 days before randomization; Diarrhea is defined as watery stools and/or daily defecation ≥ 3 times. Constipation is defined as the inability to achieve at least one defecation per day; * (Medical Inquiry/Examination) During the screening, individuals with acute cholecystitis, chronic cholecystitis; or those with symptomatic or treatable gallstones at the time of screening; or those with symptomatic or treatable gallbladder polyps at the time of screening; * (Medical Inquiry) Individuals previously diagnosed with thyroid C-cell carcinoma, MEN (Multiple Endocrine Adenoma Disease) type 2A or 2B, or with a related family history; * (Medical Inquiry) Individuals previously diagnosed with acute or chronic pancreatitis, or pancreatic injury; * (Medical Inquiry/Query) Individuals who used any prescription drugs or over-the-counter drugs (including chemical drugs, vitamin drugs, herbal drugs, etc.) within 2 weeks before screening; * (Examination) Individuals with any positive results for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody during the screening period; * (Examination) At the screening/baseline, 12-lead electrocardiogram shows a heart rate of \< 50 beats per minute or \> 100 beats per minute, second or third degree atrioventricular conduction block, long QT syndrome or for women QTcF \> 470 ms or for men \> 450 ms or other electrocardiogram abnormalities judged by the investigator as requiring drug intervention; * (Medical Inquiry) Individuals with a history of fainting during blood transfusion or needle phobia; * (Medical Inquiry) Individuals who have taken drugs or had drug abuse history within 6 months before screening; * (Medical Inquiry) Individuals who smoked more than 10 cigarettes per day on average (including nicotine replacement products) within 3 months before screening, or who could not prohibit smoking throughout the trial stay; * (Medical Inquiry) Individuals who frequently drank alcohol within the 3 months before screening, that is, with an average daily alcohol intake of more than 2 units (1 unit = 17.7 mL ethanol, that is, 1 unit = 357 mL alcohol for 5% beer or 43 mL alcohol for 40% liquor or 147 mL alcohol for 12% wine) or who could not abstain from alcohol throughout the trial stay; * (Medical Inquiry) Individuals who donated blood or lost more than 400 mL of blood within 3 months before screening or plan to donate blood during or after the trial; * (Medical Inquiry/Query) Individuals who participated in drug or medical device clinical trials and received trial drugs (except for placebo) or medical device interventions within 3 months before screening; * (Medical Inquiry) Individuals who received any vaccine or plan to receive a vaccine during screening; * (Medical Inquiry/Examination) Female participants who are pregnant or lactating, or those with positive pregnancy test results during the screening period; * (Examination) Individuals with positive urine drug or alcohol breath screening at the baseline period; * Individuals determined by the investigator to be unsuitable to participate in this study or who withdrew from the study for personal reasons

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As listed by the trial registrant

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How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Hangzhou First People's Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310006, China