A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder

Completed · Phase 1

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

The study will determine the safety, tolerability, and pharmacokinetics of aripiprazole lauroxil in adults with schizophrenia or schizoaffective disorder.

Key facts

Study ID

NCT02636842

Run by

Alkermes, Inc.

People needed

47

Starts

2015-12-01

Expected to finish

2016-06-01

Last updated by the study team

2016-07-14

Who can join

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

You may qualify if…

• Has a diagnosis of chronic 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 40.0 kg/m2, inclusive
• Additional criteria may apply

You may not qualify if…

• Is pregnant, is planning to become pregnant, or is currently breastfeeding
• Has received aripiprazole lauroxil or IM depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months or currently treated with clozapine
• 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 — Cerritos, California, United States
• Alkermes Investigational Site — Lemon Grove, California, United States
• Alkermes Investigational Site — Oakland, California, United States
• Alkermes Investigational Site — Hoffman Estates, Illinois, United States
• Alkermes Investigational Site — Marlton, New Jersey, United States
• Alkermes Investigative Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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