Clinical Trial

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

Completed Phase 1
View on ClinicalTrials.gov →
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.
Protocol Amendment History 4 changes
critical Trial completed 2026-07-25
notable Enrollment increased: 26 -> 33 participants 2026-07-25
notable Primary completion moved earlier: 2026-07-31 -> 2025-11-26 2026-07-25
minor Completion moved earlier: 2026-07-31 -> 2025-11-26 2026-07-25
Trial Details
NCT Number NCT06557902
Lead Sponsor Intra-Cellular Therapies, Inc.
Conditions Autism Spectrum Disorder
Enrollment 33 participants
Start Date 2024-05-10
Primary Completion 2025-11-26 (estimated)
Study Completion 2025-11-26 (estimated)
Updated on ClinicalTrials.gov 2026-07-24