Lurasidone Pediatric Pharmacokinetics Study

Inclusion Criteria

• Subjects must provide written informed consent, if emancipated, written assent and be willing to participate in the study. Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects' adherence to the study procedures must be obtained for subjects who are not emancipated.
• Male or female subjects 6 to 17 years of age, inclusive. Subject must be 17 years or less at the follow-up visit.
• Subject is judged by the investigator to be clinically stable (ie, no psychiatric hospitalization within the past 12 weeks; no imminent risk of suicide or injury to self, others or property; no recent addition, or change in dosage, of psychotropic medication intended for the treatment of the primary psychiatric condition in the past 4 weeks) but symptomatic (ie, some active symptoms of the primary psychiatric condition are present for which an atypical antipsychotic agent is judged to be an acceptable treatment option).
• Subjects with the following diagnoses will be eligible for participation: primary schizophrenia spectrum diagnosis (schizophrenia, schizoaffective, schizophreniform or psychotic disorder Not Otherwise Specified (NOS), bipolar spectrum disorder (bipolar I, II or bipolar NOS), pervasive developmental disorder (PDD) including autistic spectrum disorder (autistic disorder, Asperger's syndrome, or Pervasive Developmental Disorder-Not Otherwise Specified (PDD-NOS), attention-deficit hyperactivity (ADHD) with aggressive behavior [meeting co-morbid diagnostic criteria for Conduct Disorder/Disruptive Behavior Disorders Not Otherwise Specified (CD/DBD NOS), or Tourette's syndrome, via clinical interview (using MINI-Kid plus diagnostic interview and the Diagnostic and Statistical Manual of Mental Disorders, 4th edition Text Revision (DSM-IV-TR) as a reference). Autistic disorder should also be confirmed by the Autism Diagnostic Interview, Revised (ADI-R).
• Within 5th to 95th percentile for gender specific weight-for-age and height-for-age Growth Charts from National Center for Health Statistics.
• No clinically relevant abnormal laboratory values.
• No clinically relevant abnormal vital sign values/findings.
• Females who participate in this study:
• are unable to become pregnant (eg, premenarchal, surgically sterile etc) -OR-
• are willing to remain sexually abstinent (not engage in sexual intercourse) from Day 1 to 30 days after discharge on Day 11; -OR-
• are sexually active and willing to use an effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from Day -1 to 30 days after discharge on Day 11.
• Males must be willing to remain sexually abstinent or use an effective method of birth control (eg, condom) from Day -1 to 30 days after discharge on Day 11.
• Willing and able to remain off any antipsychotic medication other than lurasidone for the duration of the study, if, in the investigator's opinion the subject is not at risk for worsening symptoms.
• Willing and able to swallow the size and number of lurasidone tablets specified per protocol.
• Willing and able to adhere to protocol-specified meal requirements during dosing.
• Have a stable living arrangement for at least 3 months prior to Day -1 and agrees to return to a similar living arrangement after discharge on Day 11. Homeless subjects may not be enrolled.

Exclusion Criteria

• Clinically significant neurological, metabolic (including type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, carcinoma, and/or urological disorder such as unstable angina, congestive heart failure (uncontrolled), or central nervous system (CNS) infection that would pose a risk to the subjects if they were to participate in the study or that might confound the results of the study.
• Note: Active medical conditions that are minor or wel