Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder
Phase 1
Recruiting
- Conditions
- Autism Spectrum Disorder
- Interventions
- Registration Number
- NCT06557902
- Lead Sponsor
- Intra-Cellular Therapies, Inc.
- Brief Summary
Study ITI-007-035 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone for pediatric patients with Autism Spectrum Disorder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
- Male or female patients between 5 to less than 13 years of age
- Primary clinical diagnosis of ASD with symptoms of irritability
- ABC-I subscale score of ≥12 at Screening
- CGI-S score of ≥3 at Screening
- Body mass index (BMI) greater than the 5th percentile according to age- and gender-specific CDC Clinical Growth Charts (2000) at Screening
- Ability to swallow capsules
Exclusion Criteria
- Has a primary psychiatric diagnosis other than ASD
- Reports suicidal ideation (Type 3, 4 or 5 on the Baseline/Screening version of the C-SSRS) within 6 months prior to Screening, or any suicidal behavior within 2 years prior to Screening, 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 ECG or a QT interval corrected for heart rate using Fridericia formula (QTcF) > 460 msec at Screening
- Patients with a history of orthostatic hypotension or who have orthostatic hypotension at Screening
- Has a history of uncontrolled/disruptive behavior in the past 30 days that, in the Investigator's opinion, would preclude the ability to participate in study procedures
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 (5 to less than 10 years) Lumateperone 10.5 mg ODT Lumateperone ODT once daily: 5 mg on Days 1 and 2; 5 mg or 10.5 mg on Day 3; 5 mg or 10.5 mg on Days 4 and 5; dosing regimen may be adjusted after the first 6 patients dosed and will not exceed 21 mg in subsequent patients Group 1 (10 to less than 13 years) Lumateperone 21 mg capsule Lumateperone capsule once daily: 10.5 mg on Days 1 and 2; 10.5 mg or 21 mg on Day 3; 10.5 mg or 21 mg on Days 4 and 5 Group 2 (5 to less than 10 years) Lumateperone 21 mg ODT Lumateperone ODT once daily: 5 mg on Days 1 and 2; 5 mg or 10.5 mg on Day 3; 5 mg or 10.5 mg on Days 4 and 5; dosing regimen may be adjusted after the first 6 patients dosed and will not exceed 21 mg in subsequent patients Group 1 (10 to less than 13 years) Lumateperone 10.5 mg capsule Lumateperone capsule once daily: 10.5 mg on Days 1 and 2; 10.5 mg or 21 mg on Day 3; 10.5 mg or 21 mg on Days 4 and 5 Group 2 (5 to less than 10 years) Lumateperone 5 mg ODT Lumateperone ODT once daily: 5 mg on Days 1 and 2; 5 mg or 10.5 mg on Day 3; 5 mg or 10.5 mg on Days 4 and 5; dosing regimen may be adjusted after the first 6 patients dosed and will not exceed 21 mg in subsequent patients Group 2 (5 to less than 10 years) Lumateperone 15.5 mg ODT Lumateperone ODT once daily: 5 mg on Days 1 and 2; 5 mg or 10.5 mg on Day 3; 5 mg or 10.5 mg on Days 4 and 5; dosing regimen may be adjusted after the first 6 patients dosed and will not exceed 21 mg in subsequent patients
- Primary Outcome Measures
Name Time Method Pharmacokinetics: AUC0-tau Day 5 Area under the plasma lumateperone concentration time curve from time zero to the end of dosing (tau)
Pharmacokinetics: Cmax Day 5 Maximum plasma concentration of lumateperone
Pharmacokinetics: Tmax Day 5 Time of maximum plasma concentration of lumateperone
- Secondary Outcome Measures
Name Time Method Percentage of patients with treatment-emergent adverse events Up to 30 days after last dose Change from baseline in systolic and diastolic blood presssure Day 6 Change from baseline in ECG QT interval Day 6 Change from baseline in white blood cell count Day 6 Change from baseline in aspartate aminotransferase Day 6 Change from baseline in alanine aminotransferase Day 6 Change from baseline in hemoglobin Day 6 Change from baseline in Abnormal Involuntary Movement Scale (AIMS) Day 6 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).
Trial Locations
- Locations (8)
Clinical Site 6
🇺🇸Miami, Florida, United States
Clinical Site 1
🇺🇸Atlanta, Georgia, United States
Clinical Site 4
🇺🇸Saint Charles, Missouri, United States
Clinical Site 7
🇺🇸Orlando, Florida, United States
Clinical Site 2
🇺🇸Decatur, Georgia, United States
Clinical Site 5
🇺🇸Lincoln, Nebraska, United States
Clinical Site 3
🇺🇸Savannah, Georgia, United States
Clinical Site 8
🇺🇸Everett, Washington, United States