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

A Phase 1, Randomized, Open-Label Study Evaluating the Pharmacokinetics of Various Dosing Regimens of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia

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

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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