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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Aripiprazole; Aripiprazole lauroxil

Criteria

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