# Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder

> **NCT06627413** · PHASE1 · COMPLETED · sponsor: **Intra-Cellular Therapies, Inc.** · enrollment: 52 (actual)

## Conditions studied

- Schizophrenia or Schizoaffective

## Interventions

- **DRUG:** Lumateperone Capsule
- **DRUG:** Lumateperone LAI
- **DRUG:** Lumateperone LAI
- **DRUG:** Lumateperone LAI
- **DRUG:** Lumateperone LAI
- **DRUG:** Lumateperone LAI

## Key facts

- **NCT ID:** NCT06627413
- **Lead sponsor:** Intra-Cellular Therapies, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2024-08-23
- **Primary completion:** 2025-11-20
- **Final completion:** 2025-11-20
- **Target enrollment:** 52 (ACTUAL)
- **Last updated:** 2026-03-12


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06627413

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06627413, "Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT06627413. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*