A Food Effect Study of LY03020 in Healthy Subjects

Luye Pharma Group

Status and phase

Active, not recruiting

Phase 1

Conditions

Schizophrenia

Alzheimer's Disease Psychosis

Treatments

Drug: LY03020

Study type

Interventional

Funder types

Industry

Identifiers

NCT07292233

LY03020/CT-CHN-102

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18 to 45 years old

Volunteers

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.