Phase 1
N=26
Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder
Schizophrenia · Pediatric
Bottom Line
View on ClinicalTrials.gov: NCT04779177 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Pharmacokinetics: Cmax — 19.12; 23.22 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Lumateperone 42 mg (Drug); Lumateperone 28 mg (Drug)
- Age
- Pediatric · 13+ yrs
- Sex
- All
- Sponsor
- Intra-Cellular Therapies, Inc.
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics: Cmax |
19.12; 23.22 | — |
| PRIMARY Pharmacokinetics: Tmax |
1.000; 1.000 | — |
| PRIMARY Pharmacokinetics: AUC0-t |
43.612; 54.975 | — |
| PRIMARY Pharmacokinetics: AUC0-tau |
48.158; 58.437 | — |
| PRIMARY Pharmacokinetics: t1/2 |
2.208; 2.681 | — |
| PRIMARY Pharmacokinetics: CL/F |
3062.0; 947.14 | — |
| SECONDARY Percentage of Subjects With Treatment-emergent Adverse Events |
16 | — |
| SECONDARY Change From Baseline in Systolic and Diastolic Blood Pressure |
0.7; -0.5 | — |
| SECONDARY Change From Baseline in ECG QT Interval |
-3.4 | — |
| SECONDARY Change From Baseline in Hemoglobin |
-0.50 | — |
| SECONDARY Change From Baseline in White Blood Cell Count |
-0.24 | — |
| SECONDARY Change From Baseline in Aspartate Aminotransferase |
-4.0 | — |
| SECONDARY Change From Baseline in Alanine Aminotransferase |
-3.2 | — |
| SECONDARY Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) |
0.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT04779177). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.