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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04779177
• Other study ID #: ITI-007-020
• Status: Completed
• Phase: Phase 1
• Start date: March 12, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: December 2022
• Source: Intra-Cellular Therapies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric
• Psychotic Disorders
• Schizophrenia

Intervention

Drug:
• Lumateperone 42 mg
Lumateperone 42 mg, oral administration
• Lumateperone 28 mg
Lumateperone 28 mg, oral administration

Locations

Country	Name	City	State
United States	Clinical Site	Atlanta	Georgia
United States	Clinical Site	Decatur	Georgia
United States	Clinical Site	Hollywood	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Intra-Cellular Therapies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Cmax	Maximum plasma concentration of lumateperone and metabolites	predose and multiple timepoints up to 24 hours postdose on Day 1 and Day 5
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Pharmacokinetics: CL/F	Apparent oral clearance of lumateperone	predose and multiple timepoints up to 24 hours postdose on Day 1 and Day 5
Secondary	Percentage of subjects with treatment-emergent adverse events		up to 30 days after last dose
Secondary	Change from baseline in systolic and diastolic blood pressure		up to Day 20
Secondary	Change from baseline in ECG QT interval		up to Day 6
Secondary	Change from baseline in hemoglobin		screening, Day 6
Secondary	Change from baseline in white blood cell count		screening, Day 6
Secondary	Change from baseline in aspartate aminotransferase		screening, Day 6
Secondary	Change from baseline in alanine aminotransferase		screening, Day 6
Secondary	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