An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia

Completed · Phase 1

Conditions studied: Schizophrenia

In brief

This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of various doses and dosing intervals of aripiprazole lauroxil.

Key facts

Study ID

NCT02320032

Run by

Alkermes, Inc.

People needed

140

Starts

2014-12-01

Expected to finish

2016-04-01

Last updated by the study team

2018-08-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has stable schizophrenia or schizoaffective disorder
• Has demonstrated ability to tolerate aripiprazole
• Has been on a stable antipsychotic medication regimen without any changes for at least 2 months prior to screening
• Has a body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive
• Additional criteria may apply

You may not qualify if…

• Is pregnant, breastfeeding, or is planning to become pregnant during the study period
• Has received aripiprazole lauroxil or IM depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months
• Is a danger to himself/herself at screening or upon admission
• Has a history of or positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
• Has a positive urine drug screen at screening or Day 1
• Additional criteria may apply

Where it is running

• Alkermes Investigational Site — Little Rock, Arkansas, United States
• Alkermes Investigational Site — Cerritos, California, United States
• Alkermes Investigational Site — Garden Grove, California, United States
• Alkermes Investigational Site — Washington D.C., District of Columbia, United States
• Alkermes Investigational Site — Lauderhill, Florida, United States
• Alkermes Investigational Site — Leesburg, Florida, United States
• Alkermes Investigational Site — Maitland, Florida, United States
• Alkermes Investigational Site — Oakland Park, Florida, United States
• Alkermes Investigational Site — Tampa, Florida, United States
• Alkermes Investigational Site — Atlanta, Georgia, United States
• Alkermes Investigational Site — Chicago, Illinois, United States
• Alkermes Investigational Site — Hoffman Estates, Illinois, United States
• Alkermes Investigational Site — St Louis, Missouri, United States
• Alkermes Investigational Site — Marlton, New Jersey, United States
• Alkermes Investigational Site — Austin, Texas, United States
• Alkermes Investigational Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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