Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder

Inclusion Criteria: * Subject's parent(s)/legal guardian(s) is considered reliable by the Investigator and has agreed to provide support to the subject to ensure compliance with study treatment, visits, and protocol procedures. * Male and female subjects between 10 and 12 years of age, inclusive. * Subject weighs ≥70 pounds. * Subjects who are receiving antipsychotic treatment for their medical condition, with a diagnosis of bipolar I disorder. * Subjects must be considered stable, per investigator judgement. * Subject is willing to abide by the contraception requirements for the duration of the study. Exclusion Criteria: * Subject has a comorbid neuropsychiatric disorder that could interfere with participation in the study. * Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale by a response of "Yes" to question numbers 4 or 5 with ideation or suicidal behavior occurring in the past 12 months (assessed at Screening and at Visit 2, Day 1). * Subject has a diagnosis of diabetes or presents with pre-diabetes lab results (hemoglobin A1c ≥6%). * Subject has a history of use of clozapine or use of long-acting injectable antipsychotic medication within 3 months prior to Screening. * Subject has a DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) diagnosis of moderate to severe alcohol disorder, or moderate to severe substance use disorder, within the 3 months prior to Screening. …