NCT06557902

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

An Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumateperone in Pediatric Patients, Ages 5 to Less Than 13 Years, Diagnosed With Autism Spectrum Disorder

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Intra-Cellular Therapies, Inc. · Industry
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Lumateperone 10.5 mg capsule	Lumateperone 10.5 mg capsule, oral administration
DRUG	Lumateperone 21 mg capsule	Lumateperone 21 mg capsule, oral administration
DRUG	Lumateperone 5 mg ODT	Lumateperone 5 mg ODT, oral administration
DRUG	Lumateperone 10.5 mg ODT	Lumateperone 10.5 mg ODT, oral administration
DRUG	Lumateperone 15.5 mg ODT	Lumateperone 5 mg ODT + 10.5 mg ODT, oral administration
DRUG	Lumateperone 21 mg ODT	Lumateperone 21 mg ODT, oral administration

Timeline

• Start date: 2024-05-10
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2024-08-16
• Last updated: 2024-08-16

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study