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Active, Not Recruiting

NCT Number: NCT07292233

A Food Effect Study of LY03020 in Healthy Subjects

This is a randomized, open-label, single-dose, two-period, crossover study to assess the food effect on pharmacokinetics (PK) and safety of LY03020 in healthy subjects.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Schizophrenia Alzheimer's Disease Psychosis Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing AnDing Hospital Capital Medical University

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY03020

Drug

single dose，administered orally for each period

Primary outcomes

  1. Maximum observed concentration (Cmax) of LPM787000048 in plasma

    Time frame: up to Day 12

  2. Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM787000048 in plasma

    Time frame: up to Day 12

  3. Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC0-t) of LPM787000048 in plasma

    Time frame: up to Day 12

Secondary outcomes

  1. Time to maximum observed concentration (Tmax) of LPM787000048 in plasma

    Time frame: up to Day 12

  2. Apparent terminal elimination half-life (t1/2) of LPM787000048 in plasma

    Time frame: up to Day 12

  3. Number of participants with adverse events (AEs).

    Time frame: up to Day 12

Sponsors and collaborators

Lead sponsor

Luye Pharma Group Ltd.

Industry

Registry information

Official study title

A Randomized, Open-Label, Single-Dose, Two-Period, Crossover Phase I Clinical Study to Evaluate the Food Effect on the Pharmacokinetics of LPM787000048 Maleate Extended-Release Tablets (LY03020) in Healthy Subjects

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 18, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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