drugset
drugset / Trial / NCT04779177

Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder

NCT04779177 ↗

Phase 1 Completed 26 enrolled Intra-Cellular Therapies, Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

Study ITI-007-020 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone as treatment for adolescent patients with schizophrenia or schizoaffective disorder.

Timeline

Start
2021-03-12
Primary completion
2022-07-30
Completion
2022-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Lumateperone Small molecule 28 mg Oral
Subject Lumateperone Small molecule 42 mg Oral

Indications

schizophrenia