Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder

An Open-label Multiple Oral Dose Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lumateperone in Patients, Ages 13 to 17 Years, Diagnosed With Schizophrenia or Schizoaffective Disorder

Study ITI-007-020 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone as treatment for adolescent patients with schizophrenia or schizoaffective disorder.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Pediatric
• Intervention / Treatment: Drug: Lumateperone 42 mg; Drug: Lumateperone 28 mg

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Hollywood, Florida, United States, 33024
      • Clinical Site
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Clinical Site
    • Decatur, Georgia, United States, 30030
      • Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

Main Inclusion Criteria:

• Male or female patients between 13 and 17 years of age, inclusive
• Clinical diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
• Free from acute exacerbation of their psychosis for at least 3 months prior to Screening
• Clinical Global Impression - Severity (CGI-S) score ≤ 4
• Body mass index (BMI) within 2 standard deviations of, age- and gender-specific body measurements (based on CDC Clinical Growth Chart, 2000)
• Ability to swallow capsules

Main Exclusion Criteria:

• Has a primary psychiatric diagnosis other than schizophrenia or schizoaffective disorder
• Reports having experienced suicidal ideation within 6 months prior to Screening, any suicidal behavior within 2 years prior to Screening based on the Columbia-Suicide Severity Rating Scale (C-SSRS), and/or the investigator assesses the patient to be 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
• History of a clinically significant cardiac disorder and/or abnormal screening electrocardiogram (ECG) or a QT interval corrected for heart rate using Fridericia formula > 450 msec in males or > 470 msec in females

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lumateperone 42 mg once daily for 5 days	Drug: Lumateperone 42 mg; Lumateperone 42 mg, oral administration
Experimental: Lumateperone 28 mg once daily for 5 days	Drug: Lumateperone 28 mg; Lumateperone 28 mg, oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics: Cmax	Maximum plasma concentration of lumateperone	Day 1 and Day 5
Pharmacokinetics: Tmax	Time of maximum concentration of lumateperone in plasma	Day 1 and Day 5
Pharmacokinetics: t1/2	Terminal elimination half-life of lumateperone	Day 1 and Day 5
Pharmacokinetics: CL/F	Apparent oral clearance of lumateperone	Day 1 and Day 5
Pharmacokinetics: AUC0-t	Area under the plasma concentration time curve from time zero to the last measurable of concentration of lumateperone	0 to 24 hours post-dose on Day 1 and Day 5
Pharmacokinetics: AUC0-tau	Area under the plasma lumateperone concentration time curve from time zero to the end of dosing (tau)	0 to 24 hours post-dose on Day 1 and Day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Treatment-emergent Adverse Events		up to 30 days after last dose, up to a total of 35 days
Change From Baseline in Systolic and Diastolic Blood Pressure		Baseline and Day 6
Change From Baseline in ECG QT Interval	QTcF	Baseline and Day 6
Change From Baseline in Hemoglobin		Baseline and Day 6
Change From Baseline in White Blood Cell Count		Baseline and Day 6
Change From Baseline in Aspartate Aminotransferase		Baseline and Day 6
Change From Baseline in Alanine Aminotransferase		Baseline and Day 6
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)	AIMS is a measure of facial and oral movements, extremity movements and trunk movements. The AIMS total score is reported based on 7 items (items 1 through 7). Each item is rated on a scale from none (0) to severe (4). The AIMS total score ranges from 0 to 28. Higher values of total AIMS score indicate increased severity in abnormal movement.	Baseline and Day 6

Collaborators and Investigators

• Sponsor: Intra-Cellular Therapies, Inc.
• Investigators: Principal Investigator: Clinical Site, Atlanta, Georgia, United States, 30331; Principal Investigator: Clinical Site, Decatur, Georgia, United States, 30030; Principal Investigator: Clinical Site, Hollywood, Florida, United States, 33024

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2021
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): November 12, 2025
• Last Update Submitted That Met QC Criteria: October 22, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia; lumateperone
• Other Study ID Numbers: ITI-007-020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No