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

Intra-Cellular Therapies

Status and phase: Completed; Phase 1

Conditions: Schizophrenia; Pediatric

Treatments: Drug: Lumateperone 28 mg; Drug: Lumateperone 42 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04779177

ITI-007-020

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Lumateperone 42 mg once daily for 5 days

Experimental group

Treatment:

Drug: Lumateperone 42 mg

Lumateperone 28 mg once daily for 5 days

Experimental group

Treatment:

Drug: Lumateperone 28 mg