Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder
Completed · Phase 1 · NCT06557902
Conditions: Autism Spectrum Disorder
At a glance
- Research payments reported, 2025
- $975,033
- U.S. investigators named
- 5
- Sites paid
- 3
- Planned or actual enrollment
- 33
About the trial
- Sponsor
- Intra-Cellular Therapies, Inc.
- Tested
- Lumateperone 10.5 mg capsule (drug), Lumateperone 21 mg capsule (drug), Lumateperone 5 mg ODT (drug), Lumateperone 10.5 mg ODT (drug), Lumateperone 15.5 mg ODT (drug), Lumateperone 21 mg ODT (drug)
- Dates
- Started 2024-05-10; completion 2025-11-26
- Results posted
- Not yet
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.
From ClinicalTrials.gov, last updated 2026-07-24. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Iti, Inc. (d/b/a Intra-cellular Therapies, Inc.) reported $975,033 in research payments for this study in 2025 (56 payments).
Products named: Caplyta
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Yael R. Elfassy, M.D. Pediatrics · Savannah, GA
- Kimball A. Johnson, MD Internal Medicine · Atlanta, GA
- Robert A. Riesenberg, MD Psychiatry · Atlanta, GA
- Walter J. Duffy, MD Psychiatry · Lincoln, NE
- Elyssa L. Barron, M.D. Psychiatry · White Plains, NY
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Cenexel Iresearch LLC $471,723
- Atlanta Center for Medical Research Inc $297,975
- Alivation Research LLC $205,334
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.