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

Primary Purpose

Schizophrenia, Pediatric

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Lumateperone 42 mg

Lumateperone 28 mg

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Clinical Site
Clinical Site
Clinical Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Lumateperone 42 mg once daily for 5 days

Lumateperone 28 mg once daily for 5 days

Arm Description

Outcomes

Primary Outcome Measures

Pharmacokinetics: Cmax

Maximum plasma concentration of lumateperone and metabolites

Pharmacokinetics: Tmax

Time of maximum concentration of lumateperone and metabolites in plasma

Pharmacokinetics: AUC0-t

Area under the plasma concentration time curve from time zero to the last measurable of concentration of lumateperone and metabolites

Pharmacokinetics: AUC0-tau

Area under the plasma concentration (lumateperone and metabolites) time curve from time zero to the end of dosing (tau)

Pharmacokinetics: t1/2

Terminal elimination half-life of lumateperone and metabolites

Pharmacokinetics: CL/F

Apparent oral clearance of lumateperone

Secondary Outcome Measures

Percentage of subjects with treatment-emergent adverse events

Change from baseline in systolic and diastolic blood pressure

Change from baseline in ECG QT interval

Change from baseline in hemoglobin

Change from baseline in white blood cell count

Change from baseline in aspartate aminotransferase

Change from baseline in alanine aminotransferase

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).

Full Information

NCT ID

NCT04779177

First Posted

February 26, 2021

Last Updated

December 1, 2022

Sponsor

Intra-Cellular Therapies, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04779177

Brief Title

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

Official Title

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 Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

March 12, 2021 (Actual)

Primary Completion Date

July 30, 2022 (Actual)

Study Completion Date

July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Intra-Cellular Therapies, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Pediatric

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lumateperone 42 mg once daily for 5 days

Arm Type

Experimental

Arm Title

Lumateperone 28 mg once daily for 5 days

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Lumateperone 42 mg

Intervention Description

Lumateperone 42 mg, oral administration

Intervention Type

Drug

Intervention Name(s)

Lumateperone 28 mg

Intervention Description

Lumateperone 28 mg, oral administration

Primary Outcome Measure Information:

Title

Pharmacokinetics: Cmax

Description

Maximum plasma concentration of lumateperone and metabolites

Time Frame