Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder
Completed · Phase 1
Conditions studied: Schizophrenia or Schizoaffective
In brief
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.
Key facts
- Study ID
- NCT06627413
- Run by
- Intra-Cellular Therapies, Inc.
- People needed
- 52
- Starts
- 2024-08-23
- Expected to finish
- 2025-11-20
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Collaborative Neuroscience Research, LLC — Los Alamitos, California, United States
- CenExeli Research LLC — Atlanta, Georgia, United States
- Atlanta Center for Medical Research — Atlanta, Georgia, United States
- Hassman Research Institute, LLC. — Marlton, New Jersey, United States
Full record on ClinicalTrials.gov
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