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

Phase 1

Completed

• Conditions: Schizophrenia; Pediatric
• Interventions: Drug: Lumateperone 42 mg; Drug: Lumateperone 28 mg

• Registration Number: NCT04779177
• Lead Sponsor: Intra-Cellular Therapies, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-03
• Study Start: 2021-03-12
• Primary Completion: 2022-07-30
• Study Completion: 2022-07-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Lumateperone 42 mg once daily for 5 days	Lumateperone 42 mg	-
Lumateperone 28 mg once daily for 5 days	Lumateperone 28 mg	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: AUC0-tau	Day 1 and Day 5	Area under the plasma lumateperone concentration time curve from time zero to the end of dosing (tau)
Pharmacokinetics: CL/F	Day 1 and Day 5	Apparent oral clearance of lumateperone
Pharmacokinetics: Cmax	Day 1 and Day 5	Maximum plasma concentration of lumateperone
Pharmacokinetics: AUC0-t	Day 1 and Day 5	Area under the plasma concentration time curve from time zero to the last measurable of concentration of lumateperone
Pharmacokinetics: Tmax	Day 1 and Day 5	Time of maximum concentration of lumateperone in plasma
Pharmacokinetics: t1/2	Day 1 and Day 5	Terminal elimination half-life of lumateperone

Secondary Outcome Measures

Name	Time	Method
Change from baseline in white blood cell count	Day 6
Percentage of subjects with treatment-emergent adverse events	up to 30 days after last dose
Change from baseline in ECG QT interval	Day 6
Change from baseline in hemoglobin	Day 6
Change from baseline in alanine aminotransferase	Day 6
Change from baseline in Abnormal Involuntary Movement Scale (AIMS)	Day 6	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).
Change from baseline in aspartate aminotransferase	Day 6
Change from baseline in systolic and diastolic blood pressure	Day 6

Trial Locations

Locations (1)

Clinical Site; 🇺🇸 Decatur, Georgia, United States