NCT05321602

Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder

A Randomized, Single-Dose, Open-Label, Parallel-Group Study to Evaluate the Pharmacokinetic Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, single-dose, open-label, parallel-group study. Patients will undergo the screening evaluations to determine eligibility within 28 days prior to study drug administration. Approximately 80 eligible patients will be randomized in a 1:1:1:1 ratio to 1 of 4 treatment groups.

Detailed description

This is a randomized, single-dose, open-label, parallel-group study. Patients will undergo the screening evaluations to determine eligibility within 28 days prior to study drug administration. Approximately 80 eligible patients will be randomized in a 1:1:1:1 ratio to 1 of 4 treatment groups. Patients will be admitted to the clinical facilities the day (Day 0) before dosing, and will be randomized and receive a single dose on Day 1. Patients will be discharged on Day 2 after PK collection. All patients will return to the clinical site at designated study days for PK sample collections and assigned clinical procedures (Table 1). End of study evaluation will be completed on Day 176 or at early withdrawal. For patients who have never taken paliperidone or risperidone, tolerability will be tested with oral risperidone (1 mg risperidone taken orally for 3 consecutive days) at Screening approximately 14 days but no less than 9 days prior to dosing.

Conditions

• Schizophrenia
• Psychotic Disorders
• Mood Disorders
• Schizophrenia Spectrum and Other Psychotic Disorders
• Mental Disorders
• Antipsychotic Agents
• Tranquilizing Agents
• Central Nervous System Depression
• Physiological Effects of Drugs
• Psychotropic Drugs
• Neurotransmitter Agents
• Molecular Mechanisms of Pharmacological Action

Interventions

Type	Name	Description
DRUG	LY03010 156 mg treatment group, deltoid	LY03010 is white to off-white sterile aqueous extended-release suspension of paliperidone palmitate for IM injection.
DRUG	LY03010 156 mg treatment group, gluteal	LY03010 is white to off-white sterile aqueous extended-release suspension of paliperidone palmitate for IM injection.
DRUG	LY03010 351 mg treatment group, deltoid	LY03010 is white to off-white sterile aqueous extended-release suspension of paliperidone palmitate for IM injection.
DRUG	LY03010 351 mg treatment group, gluteal	LY03010 is white to off-white sterile aqueous extended-release suspension of paliperidone palmitate for IM injection.

Timeline

• Start date: 2021-09-08
• Primary completion: 2022-09-23
• Completion: 2022-10-23
• First posted: 2022-04-11
• Last updated: 2024-03-19

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study