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Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Phase 1b, Open-label Study to Determine the Pharmacokinetics, Safety, and Tolerability of Single, Ascending Doses of Lumateperone Long-acting Injectable Formulations Administered Intramuscularly to Patients With Schizophrenia or Schizoaffective Disorder

NCT06627413•Intra-Cellular Therapies, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female patients between 18 and 55 years of age, inclusive;
•Clinical diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
•Clinically stable and free from acute exacerbation of psychosis for at least 3 months prior to Screening;
•Clinical Global Impression - Severity (CGI-S) score ≤ 3 at Screening and prior to dosing on Day 1;
•Body mass index (BMI) between 18.0 and 38.0 kg/m2, inclusive at Screening, and a minimum body weight of 50 kg at Screening.

Exclusion Criteria

•History of psychiatric condition other than schizophrenia that, in the Investigator's opinion, may be detrimental to participation in the study;
•Any suicidal ideation or wish to be dead within the past 6 months of Screening, any suicide attempt within the past 2 years prior to Screening, or any current concern for the patient's safety based on the Columbia-Suicide Severity Rating Scale (C-SSRS) (excluding self-injurious, non-suicidal behavior), and/or Investigator assessment that the patient is a safety risk to him/herself or others;
•Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the patient at risk or interfere with study outcome variables;
•Has a QT interval corrected for heart rate using Fridericia formula \> 450 msec in males or \> 470 msec in females, or evidence of clinically significant bundle branch blocks on ECG at Screening.

Locations (4)

Clinical Site 2

Los Alamitos, California, United States

Clinical Site 3

Atlanta, Georgia, United States

Clinical Site 4

Decatur, Georgia, United States

Clinical Site 1

Marlton, New Jersey, United States

Key Dates

Start Date

August 23, 2024

Primary Completion Date

November 20, 2025

Completion Date

November 20, 2025

Last Updated

March 12, 2026

Enrollment

ACTUAL participants

Conditions

Schizophrenia or Schizoaffective

Interventions

Lumateperone Capsule

DRUG

Lumateperone LAI

DRUG

Lumateperone LAI

DRUG

Lumateperone LAI

DRUG

Lumateperone LAI

DRUG

Lumateperone LAI

DRUG

Identifying Predictors of Response to Antipsychotics Using a Treatment Algorithm

NCT01016145

Schizophrenia or Schizoaffective Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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