drugset
drugset / Trial / NCT06557902

Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder

NCT06557902 ↗

Phase 1 Recruiting 26 enrolled Intra-Cellular Therapies, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Study ITI-007-035 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone for pediatric patients with Autism Spectrum Disorder.

Timeline

Start
2024-05-10
Primary completion
2026-07-31
Completion
2026-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Lumateperone Small molecule 5 mg Oral
Subject Lumateperone Small molecule 10.5 mg Oral
Subject Lumateperone Small molecule 15.5 mg Oral
Subject Lumateperone Small molecule 21 mg Oral

Indications

autism spectrum disorder