RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-08-23

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06627413

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

ITI Clinical Trials

CONTACT

6464409333

ITCIClinicalTrials@itci-inc.com

Study Locations (Sites)

Clinical Site 2

Los Alamitos, California, 90720

United States

Clinical Site 3

Atlanta, Georgia, 30331

United States

Clinical Site 4

Decatur, Georgia, 30030

United States

Clinical Site 1

Marlton, New Jersey, 08053

United States

Collaborators and Investigators

Sponsor: Intra-Cellular Therapies, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-23

Study Completion Date2026-03

Study Record Updates

Study Start Date2024-08-23

Study Completion Date2026-03

Terms related to this study

Additional Relevant MeSH Terms

Schizophrenia or Schizoaffective