A Multiple Dose Safety, Tolerability and Pharmacokinetics Study in Adult Patients With Schizophrenia Following Administration of Aripiprazole IM Depot

Otsuka Pharmaceutical Development & Commercialization, Inc.41 enrolled

Overview

This study will evaluate the safety, tolerability, efficacy and pharmacokinetics of aripiprazole intramuscular (IM) depot multiple doses every 4 weeks in adult patients with schizophrenia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia

Interventions

aripiprazole IM depotDRUG

Aripiprazole IM depot supplied as 200 mg or 400 mg vials of lyophilized aripiprazole powder to prepare for IM injection.

aripiprazole tabletsDRUG

Aripiprazole tablets 10 mg once daily in the morning for 14 days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria * good physical health as determined by normal medical history, clinical laboratory results, electrocardiograms (ECGs) and physical examinations * ability to provide informed consent and/or consent from a legally acceptable representation * body mass index (BMI) of 18 to 35 kg/m\^2 Exclusion Criteria: * sexually active males and females of child-bearing potential who are not practicing double barrier birth control or are not abstinent during the study plus 30 days for female or 90 days for males following the last dose of medication * history of drug or alcohol abuse within 6 months and/or positive urine drug screen * participants who consume alcohol beverages routinely * participants who consume alcohol beverages during the screening period * 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 * use of any prescription medication unless approved by Medical Monitor or Study Director * history of current hepatitis or carrier of HBsAg (Hepatitis B surface antigen) and/or Hepatitis C Virus antibodies (anti-HCV) * females who are pregnant or lactating * participants who have participated in any clinical trial involving a psychotropic medication within one month prior to enrollment; participants who have participated in a previous IM Depot study within the last 1 year; patients who have previously enrolled and received study medication in an aripiprazole IM Depot clinical trial * donation of blood or plasma to a blood bank or 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 * evidence of organ dysfunction or any clinically significant deviation from normal in the physical, electrocardiographic, or clinical laboratory examinations * patient represents a significant risk of committing suicide based on history * patients currently in an acute relapse * patients with Axis I (DSM-IV) diagnosis of schizoaffective or bipolar disorder * patients who are considered treatment-resistant to antipsychotic medication * patients with a history of neuroleptic malignant syndrome * any other sound medical reason as determined by the clinical investigator

Locations (7)

Otsuka Investigative Site

Cerritos, California, United States

Otsuka Investigative Site

Garden Grove, California, United States

Otsuka Investigative Site

Glendale, California, United States

Otsuka Investigative Site

Paramount, California, United States

Outcomes

Primary Outcomes

Number of Participants With Adverse Events as a Measure of Safety

Safety and tolerability was assessed by the number of participants with adverse events (AE). An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it was considered drug-related by the investigator. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (ie, clinically significant) change from baseline for that individual participant.

Time frame: 7 Months

Aripiprazole Maximum Steady State Plasma Concentration (Css,Max)

Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,max were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.