A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia

Completed · Phase 1 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT01493726

Run by

Alkermes, Inc.

People needed

88

Starts

2011-12-01

Expected to finish

2013-06-01

Last updated by the study team

2018-08-29

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alkermes Investigational Site — Atlanta, Georgia, United States
• Alkermes Investigational Site — Hoffman Estates, Illinois, United States
• Alkermes Investigational Site — St Louis, Missouri, United States
• Alkermes Investigational Site — Willingboro, New Jersey, United States
• Alkermes Investigational Site — Philadelphia, Pennsylvania, United States
• Alkermes Investigational Site — Irving, Texas, United States

Full record on ClinicalTrials.gov

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