An Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumateperone in Pediatric Patients, Ages 5 to Less Than 13 Years, Diagnosed With Autism Spectrum Disorder
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 33
- Locations
- 7
- Primary Endpoint
- Pharmacokinetics: AUC0-tau
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group 1 (10 to less than 13 years)
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
Intervention: Lumateperone 10.5 mg capsule (Drug)
Group 1 (10 to less than 13 years)
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
Intervention: Lumateperone 21 mg capsule (Drug)
Group 2 (5 to less than 10 years)
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
Intervention: Lumateperone 5 mg ODT (Drug)
Group 2 (5 to less than 10 years)
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
Intervention: Lumateperone 10.5 mg ODT (Drug)
Group 2 (5 to less than 10 years)
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
Intervention: Lumateperone 15.5 mg ODT (Drug)
Group 2 (5 to less than 10 years)
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
Intervention: Lumateperone 21 mg ODT (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics: AUC0-tau
Time Frame: Day 5
Area under the plasma lumateperone concentration time curve from time zero to the end of dosing (tau)
Pharmacokinetics: Cmax
Time Frame: Day 5
Maximum plasma concentration of lumateperone
Pharmacokinetics: Tmax
Time Frame: Day 5
Time of maximum plasma concentration of lumateperone
Secondary Outcomes
- Change from baseline in systolic and diastolic blood presssure(Day 6)
- Percentage of patients with treatment-emergent adverse events(Up to 30 days after last dose)
- 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)