A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine the pharmacokinetics (PK), safety, and tolerability of ALKS 9072 (also known as ALKS 9070) after 4 monthly doses in adults with chronic stable schizophrenia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkermes, Inc.

Criteria

Inclusion Criteria:

• Diagnosis of chronic schizophrenia that is clinically stable

• Body mass index (BMI) between 18.5 and 35.0 kg/m2, inclusive

• Stable antipsychotic medication regimen for >/= 2 months before Screening

• Be willing and able to be confined to an inpatient clinical research unit for a total of 37 days during the course of the study

Exclusion Criteria:

• Aripiprazole used within 30 days before Screening

• History of intolerance of or allergy or hypersensitivity to aripiprazole, its excipients, other antipsychotic agents, or INTRALIPID (including peanuts, soy, egg, or glycerol)

• Current diagnosis of an Axis I disorder other than schizophrenia

• History of seizure disorder or any condition associated with seizures

• History of neuroleptic malignant syndrome (NMS)

• Positive test result for HIV, hepatitis B surface antigen, or anti-hepatitis C antibodies

• Received medication by IM injection within 30 days before Screening

• Monoamine oxidase inhibitors (eg, phenelzine, tranylcypromine, selegiline) used within 30 days before Screening

• DSM-IV-TR diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence within 12 months before Screening

• Donation of blood or blood components within 4 weeks before Screening