NCT06793995

Effect of Food and Age on the Pharmacokinetics of LY03017

A Phase 1 Study to Evaluate the Effect of Food and Age on the Pharmacokinetics of LPM526000133 Fumarate Capsules (LY03017) in Healthy Volunteers

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study consists of 2 parts. Part A is a randomized, open-label, 2-period, crossover study to evaluate the food effect of LY03017 in healthy adults. Part B is a single-arm study to evaluate the safety and pharmacokinetics of LY03017 in elderly volunteers.

Conditions

• Alzheimer's Disease Psychosis
• Parkinson Disease Psychosis
• Negative Symptoms of Schizophrenia

Interventions

Type	Name	Description
DRUG	LY03017	single dose，administered orally for each period
DRUG	LY03017	single dose，administered orally

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2025-01-27
• Last updated: 2025-01-27

Locations

1 site across 1 country: China