A Food Effect Study of LY03020 in Healthy Subjects

NCT07292233 — Phase 1, Active not recruiting, 16 participants, Luye Pharma Group Ltd.

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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

Registry	NCT07292233
Status	Active not recruiting
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	16 (Actual)
Sponsor	Luye Pharma Group Ltd. (Industry)
Conditions	Schizophrenia, Alzheimer's Disease Psychosis
Interventions	LY03020 (Drug)
Dates	start 2025-07-30, primary completion 2025-08-27, completion 2026-03-30 (estimated), first posted 2025-12-18, last updated 2025-12-18
Locations	1 site in China

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
fasted,fed	Experimental	Drug: LY03020	Subjects will take LY03020 80mg under fasted conditions and after a standard high-fat breakfast in period 1 and 2 respectively.
fed,fasted	Experimental	Drug: LY03020	Subjects will take LY03020 80mg after a standard high-fat breakfast and under fasted conditions in period 1 and 2 respectively.

LY03020 (Drug): single dose，administered orally for each period

+Outcome measures

Primary outcomes

Maximum observed concentration (Cmax) of LPM787000048 in plasma [up to Day 12]
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM787000048 in plasma [up to Day 12]
Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC0-t) of LPM787000048 in plasma [up to Day 12]

Secondary outcomes

Time to maximum observed concentration (Tmax) of LPM787000048 in plasma [up to Day 12]
Apparent terminal elimination half-life (t1/2) of LPM787000048 in plasma [up to Day 12]
Number of participants with adverse events (AEs). [up to Day 12]

+Eligibility

Sex: All, ages: 18 Years to 45 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Beijing AnDing Hospital Capital Medical University	Beijing	China