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

Phase 1 Completed 52 enrolled Intra-Cellular Therapies, Inc.

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2024-08-23
Primary completion: 2025-11-20
Completion: 2025-11-20

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lumateperone	Small molecule	100 mg	Intramuscular
Subject	Lumateperone	Small molecule	42 mg	Oral

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

Summary

Timeline

Drugs

Indications