Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders

Exclusion Criteria

• •Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia, or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) other than those listed in the second inclusion criterion above, or direct effect of a substance (ie, medication, illicit drug use, etc.).
• •Subjects with a history of at least mild intellectual disability as determined by IQ \< 70, clinical evidence, or a social or school history that is suggestive of intellectual disability.
• •Subjects who have any of the following:
• •1. A significant risk of committing suicide based on history and the principal investigator's clinical judgment, or routine psychiatric status examination
• •2. Current suicidal behavior
• •3. Imminent risk of injury; active suicidal ideation
• •4. Any lifetime history of suicidal behavior detected by the Children's Baseline/Screening version of the C-SSRS.
• •Subjects with a lifetime history of a substance use disorder (as determined by the DSM-5 criteria), or current substance misuse including alcohol and benzodiazepines, but excluding caffeine and nicotine.
• •Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders such as any history of myocardial infarction, congestive heart failure, HIV seropositive status/acquired immunodeficiency syndrome, or chronic hepatitis B or C. Medical conditions that are minor or well-controlled may be considered acceptable if the condition does not expose the subject to an undue risk of significant adverse event or interfere with assessments during the course of the trial.
• •Subjects with insulin dependent diabetes mellitus (IDDM) are excluded. Subjects with non-IDDM may be eligible for the trial if their condition is determined to be stable.
• •Subjects with epilepsy or a history of seizures (except for a single seizure episode, for instance childhood febrile seizure or post traumatic) or a history of severe head trauma or cerebrovascular disease (eg, stroke, transient ischemic attack, etc.).
• •Any major surgery within 30 days prior to the first dose of IMP.
• •Any history of significant bleeding or hemorrhagic tendencies.
• •Blood transfusions within 30 days prior to first dose of IMP.
• •Subjects with a positive drug screen for cocaine, marijuana (even if by prescription), or other illicit drugs, or alcohol are excluded and may not be retested or rescreened.
• •Subjects who have supine or standing diastolic blood pressure, after resting for at least 5 minutes, ≥ 95 mmHg.
• •Subjects who have had a dose of depot antipsychotics within 6 months of screening.
• •Consumption of alcohol or grapefruit, grapefruit juice, Seville oranges, or Seville orange juice within 72 hours prior to the first dose of IMP and throughout the trial
• •Subjects who participated in a clinical trial and were exposed to IMP within the last 30 days prior to screening or who participated in more than 2 interventional clinical trials within the past year.
• •Subjects with a history of neuroleptic malignant syndrome or hypersensitivity to atypical antipsychotics.
• •Subjects with a history of true allergic (i.e. not intolerance) response to more than one class of medications.
• •Subjects with a history of allergic reaction or a known or suspected sensitivity to any substance that is contained in the IMP formula.
• •Subjects who do not tolerate venipuncture or have poor venous access that would cause difficulty for collecting blood samples.
• •Prisoners or subjects who are compulsorily detained (e.g. juvenile detention, court-mandated treatment) for any reason.
• •Inability to tolerate oral medication or swallow tablets.