NCT06627413

Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder

A Phase 1b, Open-label Study to Determine the Pharmacokinetics, Safety, and Tolerability of Single, Ascending Doses of Lumateperone Long-acting Injectable Formulations Administered Intramuscularly to Patients With Schizophrenia or Schizoaffective Disorder

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Intra-Cellular Therapies, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Study ITI-007-037 is a Phase 1b, open-label study to evaluate the safety, tolerability, and PK of lumateperone long-acting injectable (LAI) formulations after a single intramuscular injection in patients with stale schizophrenia or schizoaffective disorder.

Conditions

• Schizophrenia or Schizoaffective

Interventions

Type	Name	Description
DRUG	Lumateperone Capsule	Lumateperone 42 mg capsule, oral administration
DRUG	Lumateperone LAI	Lumateperone LAI X500-E2 IM injection
DRUG	Lumateperone LAI	Lumateperone LAI X500-E3 IM injection
DRUG	Lumateperone LAI	Lumateperone LAI X500-X2 IM injection
DRUG	Lumateperone LAI	Lumateperone LAI X500-X5 IM injection
DRUG	Lumateperone LAI	Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection

Timeline

• Start date: 2024-08-23
• Primary completion: 2025-11-20
• Completion: 2025-11-20
• First posted: 2024-10-04
• Last updated: 2026-03-12

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study