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

Recruiting

Phase 1

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

Sponsor:

Intra-Cellular Therapies, Inc.

Code:

NCT06557902

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

Interventions

Lumateperone 10.5 mg capsule

Lumateperone 21 mg capsule

Lumateperone 5 mg ODT

Lumateperone 10.5 mg ODT

Lumateperone 15.5 mg ODT

Study Details

Eligibility Criteria

Study Design

Interventions and Outcome Measures

Central Contacts and Locations

More Information

Trial information was received from ClinicalTrials.gov and was last updated on 2025-06-16. This information was provided to ClinicalTrials.gov by Intra-Cellular Therapies, Inc. on 2024-08-16.