Clinical trial NCT04779177: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Pediatric
Lead sponsor: Intra-Cellular Therapies, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-03
Enrollment: 26
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Pharmacokinetics: Cmax
timeFrame: Day 1 and Day 5
measure: Pharmacokinetics: Tmax
timeFrame: Day 1 and Day 5
measure: Pharmacokinetics: AUC0-t
timeFrame: Day 1 and Day 5
measure: Pharmacokinetics: AUC0-tau
timeFrame: Day 1 and Day 5
measure: Pharmacokinetics: t1/2
timeFrame: Day 1 and Day 5
measure: Pharmacokinetics: CL/F
timeFrame: Day 1 and Day 5
Secondary outcomes:
measure: Percentage of subjects with treatment-emergent adverse events
timeFrame: up to 30 days after last dose
measure: Change from baseline in systolic and diastolic blood pressure
timeFrame: Day 6
measure: Change from baseline in ECG QT interval
timeFrame: Day 6
measure: Change from baseline in hemoglobin
timeFrame: Day 6
measure: Change from baseline in white blood cell count
timeFrame: Day 6
measure: Change from baseline in aspartate aminotransferase
timeFrame: Day 6
measure: Change from baseline in alanine aminotransferase
timeFrame: Day 6
measure: Change from baseline in Abnormal Involuntary Movement Scale (AIMS)
timeFrame: Day 6
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: Clinical Site
state: Florida
city: Atlanta
country: United States
facility: Clinical Site
state: Georgia
city: Decatur
country: United States
facility: Clinical Site
state: Georgia
Study officials:
affiliation: Atlanta, Georgia, United States, 30331
name: Clinical Site
role: PRINCIPAL_INVESTIGATOR
affiliation: Decatur, Georgia, United States, 30030
name: Clinical Site
role: PRINCIPAL_INVESTIGATOR
affiliation: Hollywood, Florida, United States, 33024
name: Clinical Site
role: PRINCIPAL_INVESTIGATOR
References: