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

NCT ID NCT07292233

Knowledge-focused Sponsor: Luye Pharma Group Ltd. Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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)

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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial is testing how eating food changes the way the body absorbs a new experimental drug called LY03020. The drug is being developed for schizophrenia and psychosis related to Alzheimer's disease. Sixteen healthy volunteers will take the drug once with food and once without, so researchers can compare the levels in their blood and check for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LY03020 (LPM787000048 maleate extended-release tablets)
What this could lead to
If successful, this study could help determine the best way to take LY03020 with or without food, guiding future trials for treating schizophrenia and Alzheimer's disease psychosis.
What could go wrong
This is a very early phase 1 trial in only 16 healthy people, not patients. It only measures how food affects drug levels, not whether the drug works for the intended conditions. The drug may still fail in later trials.

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

16 people

The number who actually took part.

Started

Jul 2025

Expected to finish

Mar 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 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: * Subjects sign informed consent voluntarily. * Male or female aged 18 to 45 years. * Body weight ≥ 50.0kg for male and ≥ 45.0kg for female, and body mass index (BMI) between 18.5 and 26.0 kg/m2. Exclusion Criteria: * Subjects have any clinically significant medical condition or chronic disease. * Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma. Subjects have any abnormal and clinically significant test for ophthalmic examination during screening. * Subjects with a history of orthostatic hypotension or syncope. * Subjects with condition that may interfere with the drug absorption, distribution, metabolism and excretion significantly. * Subjects had a history of surgery within 3 months prior to administration, or had not recovered, or have a surgical plan during the study. * Subjects have any clinically significant abnormal vital signs, laboratory values, and ECGs. * Subjects have used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to first dosing. * Subjects have a history of allergic diseases, or allergic to any substance contained in the formulation. * Subjects have a positive test for HBsAg, HCV-Ab, HIV-Ab, or syphilis antibody.

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

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

Alzheimer's disease psychosis Schizophrenia

Contacts and locations

Locations

  • Beijing AnDing Hospital Capital Medical University

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.