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

NCT04779177 | Completed Phase 1 Results FDA Drug

• 1 other identifier: ITI-007-020
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Schizophrenia; Pediatric

Outcome Measures

Primary Outcomes (6)

• 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: 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

• 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

Secondary Outcomes (8)

• 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

  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

Study Arms (2)

Lumateperone 42 mg once daily for 5 days

EXPERIMENTAL

Drug: Lumateperone 42 mg

Lumateperone 28 mg once daily for 5 days

EXPERIMENTAL

Drug: Lumateperone 28 mg

Interventions

Lumateperone 42 mg DRUG

Lumateperone 42 mg, oral administration

Lumateperone 42 mg once daily for 5 days

Lumateperone 28 mg DRUG

Lumateperone 28 mg, oral administration

Lumateperone 28 mg once daily for 5 days

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead

Study Sites (3)

Clinical Site

Hollywood, Florida, 33024, United States

Location

Clinical Site

Atlanta, Georgia, 30331, United States

Location

Clinical Site

Decatur, Georgia, 30030, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

lumateperone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: ITI Clinical Trials
• Organization: Intra-Cellular Therapies, Inc.

ITCIClinicalTrials@itci-inc.com

6464409333

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 3, 2021
• Study Start: March 12, 2021
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: November 12, 2025
• Results First Posted: November 12, 2025

Record last verified: 2025-10

Locations

US (3)