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: 11 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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 and metabolites	predose and multiple timepoints up to 24 hours postdose on Day 1 and Day 5
Pharmacokinetics: Tmax	Time of maximum concentration of lumateperone and metabolites in plasma	predose and multiple timepoints up to 24 hours postdose on 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 and metabolites	predose and multiple timepoints up to 24 hours postdose on Day 1 and Day 5
Pharmacokinetics: AUC0-tau	Area under the plasma concentration (lumateperone and metabolites) time curve from time zero to the end of dosing (tau)	predose and multiple timepoints up to 24 hours postdose on Day 1 and Day 5
Pharmacokinetics: t1/2	Terminal elimination half-life of lumateperone and metabolites	predose and multiple timepoints up to 24 hours postdose on Day 1 and Day 5
Pharmacokinetics: CL/F	Apparent oral clearance of lumateperone	predose and multiple timepoints up to 24 hours postdose 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
Change from baseline in systolic and diastolic blood pressure		up to Day 20
Change from baseline in ECG QT interval		up to Day 6
Change from baseline in hemoglobin		screening, Day 6
Change from baseline in white blood cell count		screening, Day 6
Change from baseline in aspartate aminotransferase		screening, Day 6
Change from baseline in alanine aminotransferase		screening, Day 6
Change from baseline in Abnormal Involuntary Movement Scale (AIMS)	unabbreviated scale title: Abnormal Involuntary Movement Scale. AIMS is a measure of facial and oral movements, extremity movements and trunk movements. Items are rated on a scale from none (0) to severe (4).	up to 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): December 2, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders
• 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