Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.