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

NCT06627413 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-03-12

No results posted yet for this study

Summary

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.

Conditions

  • Schizophrenia or Schizoaffective

Interventions

DRUG

Lumateperone Capsule

Lumateperone 42 mg capsule, oral administration

DRUG

Lumateperone LAI

Lumateperone LAI X500-E2 IM injection

DRUG

Lumateperone LAI

Lumateperone LAI X500-E3 IM injection

DRUG

Lumateperone LAI

Lumateperone LAI X500-X2 IM injection

DRUG

Lumateperone LAI

Lumateperone LAI X500-X5 IM injection

DRUG

Lumateperone LAI

Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection

Sponsors & Collaborators

  • Intra-Cellular Therapies, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-23
Primary Completion
2025-11-20
Completion
2025-11-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06627413 on ClinicalTrials.gov