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

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- andgender-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 theC-SSRS) within 6 months prior to Screening, or any suicidal behavior within 2 yearsprior to Screening, and/or the Investigator assesses the patient to be a safety riskto him/herself or others

• Clinically significant abnormality within 2 years of Screening that in theInvestigator's opinion may place the patient at risk or interfere with study outcomevariables

• History of a clinically significant cardiac disorder and/or abnormal screening ECGor a QT interval corrected for heart rate using Fridericia formula (QTcF) > 460 msecat Screening

• Patients with a history of orthostatic hypotension or who have orthostatichypotension at Screening

• Has a history of uncontrolled/disruptive behavior in the past 30 days that, in theInvestigator's opinion, would preclude the ability to participate in studyprocedures