Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents

A Phase II Study to Test PK Tolerability in Children and Adolescents

The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of aripiprazole tablets following oral administration to children and adolescents.

Inclusion Criteria:

• Male and female children and adolescents between 10 and 17 years, inclusive, preferentially with a primary schizophrenia spectrum diagnosis or bipolar spectrum disorder.
• Good physical health as determined by no clinically significant deviation from normal in medical history, clinical laboratory determination, electrocardiograms (ECG) and physical examinations conducted within 14 days prior to study enrollment.
• Both the legal guardian and study subject must have signed written informed consent. Consent must have been obtained prior to any screening evaluations.
• Subjects must have had a caretaker or guardian who could adequately complete appropriate documentation required by the protocol.

Exclusion Criteria:

• Sexually active males and females who were not practicing double-barrier birth control, or who were not remaining abstinent, during the study and for 30 days (females only) or 90 days (males only) following the last dose of study medication.
• All sexually active females of childbearing potential must have had a negative serum pregnancy test with results available prior to receiving study drug.
• Breastfeeding females were excluded.
• History of recent (within 6 months) drug or alcohol abuse as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), Diagnostic Criteria for Drug and Alcohol Abuse and/or a positive urine screen for drugs of abuse.
• History of mental retardation or mental retardation assessed by the investigator.
• Subjects who were known to consume alcohol-containing beverages routinely.
• Subjects who consumed any alcohol-containing beverages during the screening period.
• Any neurological disorder with the exception of pervasive development disorder, attention deficit hyperactivity disorder, and Tourette's syndrome.
• Use of any antipsychotic medication, other prohibited psychotropic medication, and any cytochrome P450 2D6 (CYP2D6) and cytochrome P450 3A4 (CYP3A4) inhibitors or CYP3A4 inducers within 14 days prior to dosing and for the duration of the study.
• Use of any prescription medication not specifically approved by the medical monitor or study director.
• A positive hepatitis C antibody test.
• Females who were pregnant or lactating.
• Subjects who had participated in any clinical trial within 1 month prior to enrollment, or in a clinical trial involving psychotropic medication within 6 months prior to the end of baseline, unless permission was obtained from the sponsor.
• Donation of blood or plasma to a blood bank, or participation in a clinical study (except a screening visit) within 30 days prior to enrollment.
• Any major surgery within 30 days prior to enrollment.
• Blood transfusion within 30 days prior to enrollment.
• Inability to tolerate oral medication or swallow tablets.
• Evidence of organ dysfunction or any clinically significant deviation from normal in the physical, ECG, or clinical laboratory examinations.
• Subjects who, based upon clinical interview, presented a significant risk of suicidality or homicidality.
• Any other sound medical reason as determined by the investigator.