Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder
Completed · Phase 1 · NCT06627413
Conditions: Schizophrenia or Schizoaffective
At a glance
- Research payments reported, 2025
- $2.7M
- U.S. investigators named
- 2
- Sites paid
- 1
- Planned or actual enrollment
- 52
About the trial
- Sponsor
- Intra-Cellular Therapies, Inc.
- Tested
- Lumateperone Capsule (drug), Lumateperone LAI (drug), Lumateperone LAI (drug), Lumateperone LAI (drug), Lumateperone LAI (drug), Lumateperone LAI (drug)
- Dates
- Started 2024-08-23; completion 2025-11-20
- Results posted
- Not yet
Study ITI-007-037 is a Phase 1b, open-label study to evaluate the safety, tolerability, and PK of lumateperone long-acting injectable (LAI) formulations after a single intramuscular injection in patients with stale schizophrenia or schizoaffective disorder.
From ClinicalTrials.gov, last updated 2026-07-31. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Iti, Inc. (d/b/a Intra-cellular Therapies, Inc.) reported $2.7M in research payments for this study in 2025 (10 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
- Kimball A. Johnson, MD Internal Medicine · Atlanta, GA
- 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 Clinical Research Inc $2.7M
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.