A Trial of Single- and Multiple-doses of Aripiprazole in Adult Subjects With Schizophrenia or Bipolar I Disorder

An Open-label, Single- and Multiple-dose, Pharmacokinetic, Safety, and Tolerability Trial of Aripiprazole Long-acting Injectable Administered in the Deltoid or Gluteal Muscle in Adult Subjects With Schizophrenia or Bipolar I Disorder

The primary objective of this trial is to evaluate the pharmacokinetics (PK) of aripiprazole long-acting injectable (LAI) (420 mg) following deltoid or gluteal muscle administration in adult subjects with schizophrenia or bipolar I disorder.

Inclusion Criteria:

• Male and female subjects between 18 and 64 years of age, inclusive.
• Body mass index of 18 to 35 kg/m2, inclusive.
• A current diagnosis of schizophrenia or a current diagnosis of bipolar I disorder as defined by DSM-5 criteria.
• Prior history of tolerating aripiprazole per investigator's judgment.

Exclusion Criteria:

• Subjects who have met DSM-5 criteria for substance dependence within the past 180 days
• Use of any psychotropic medications other than their current non-aripiprazole antipsychotic or mood stabilizer(s) medication or subjects who use more than one antipsychotic or mood stabilizer(s) medication at screening.
• Subjects may not receive varenicline beyond screening.
• Use of any prescription medication not specifically approved by the medical monitor.
• Females who are pregnant or lactating. A negative serum pregnancy test must be confirmed prior to the first dose of IMP for all female subjects.
• Subjects who had participated in any clinical trial involving a psychotropic medication within 1 month prior to enrollment; subjects who had participated in a previous aripiprazole LAI trial within the last 1 year (ie, enrolled but did not receive aripiprazole LAI); or who had previously enrolled and received IMP in an aripiprazole LAI clinical trial.
• Any major surgery within 30 days prior to enrollment or scheduled/elective surgery during the trial.
• Subjects currently in an acute relapse of schizophrenia.
• Subjects with a current DSM-5 diagnosis other than schizophrenia or bipolar I disorder
• Electroconvulsive therapy must not be conducted within 2 months prior to administration of the IMP
• Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia as assessed by the investigator.
• History of or current hepatitis or acquired immunodeficiency syndrome or carriers of HBsAg, anti-HCV, and/or HIV antibodies.
• History of any significant drug allergy or known or suspected hypersensitivity, in particular to aripiprazole or other quinolinones.
• Subjects deemed intolerant of receiving injections.