Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lumateperone 42 mg once daily for 5 days
|
Drug: Lumateperone 42 mg
Lumateperone 42 mg, oral administration
|
| Experimental: Lumateperone 28 mg once daily for 5 days
|
Drug: Lumateperone 28 mg
Lumateperone 28 mg, oral administration
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetics: Cmax [predose and multiple timepoints up to 24 hours postdose on Day 1 and Day 5]
Maximum plasma concentration of lumateperone and metabolites
- Pharmacokinetics: Tmax [predose and multiple timepoints up to 24 hours postdose on Day 1 and Day 5]
Time of maximum concentration of lumateperone and metabolites in plasma
- Pharmacokinetics: AUC0-t [predose and multiple timepoints up to 24 hours postdose on Day 1 and Day 5]
Area under the plasma concentration time curve from time zero to the last measurable of concentration of lumateperone and metabolites
- Pharmacokinetics: AUC0-tau [predose and multiple timepoints up to 24 hours postdose on Day 1 and Day 5]
Area under the plasma concentration (lumateperone and metabolites) time curve from time zero to the end of dosing (tau)
- Pharmacokinetics: t1/2 [predose and multiple timepoints up to 24 hours postdose on Day 1 and Day 5]
Terminal elimination half-life of lumateperone and metabolites
- Pharmacokinetics: CL/F [predose and multiple timepoints up to 24 hours postdose on Day 1 and Day 5]
Apparent oral clearance of lumateperone
Secondary Outcome Measures
- Percentage of subjects with treatment-emergent adverse events [up to 30 days after last dose]
- Change from baseline in systolic and diastolic blood pressure [up to Day 20]
- Change from baseline in ECG QT interval [up to Day 6]
- Change from baseline in hemoglobin [screening, Day 6]
- Change from baseline in white blood cell count [screening, Day 6]
- Change from baseline in aspartate aminotransferase [screening, Day 6]
- Change from baseline in alanine aminotransferase [screening, Day 6]
- Change from baseline in Abnormal Involuntary Movement Scale (AIMS) [up to 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).
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Site | Hollywood | Florida | United States | 33024 |
| 2 | Clinical Site | Atlanta | Georgia | United States | 30331 |
Sponsors and Collaborators
- Intra-Cellular Therapies, Inc.
Investigators
- Principal Investigator: Clinical Site, Atlanta, Georgia, United States, 30331
- Principal Investigator: Clinical Site, Hollywood, Florida, United States, 33024
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ITI-007-020