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

Phase 1

Completed

• Conditions: Schizoaffective Disorder; Schizophrenia
• Interventions: Drug: Aripiprazole Lauroxil

• Registration Number: NCT02636842
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-18
• Study First Submitted QC: 2015-12-21
• Study First Posted: 2015-12-22
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-13
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Location	Aripiprazole Lauroxil	Deltoid or Gluteal Muscle

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax)	Up to 7 days

Secondary Outcome Measures

Name	Time	Method
Time to Cmax (Tmax)	Up to 7 days
Area under the concentration-time curve from time zero to the last quantifiable time interval (AUCl0-last)	Up to 7 days
Area under the concentration-time curve from time zero to time t (AUC0-t)	Up to 7 days
Terminal elimination half-life (t½)	Up to 7 days
Safety will be determined by incidence of adverse events	Up to 7 days

Trial Locations

Locations (2)

Alkermes Investigative Site; 🇺🇸 Dallas, Texas, United States

Alkermes Investigational Site; 🇺🇸 Marlton, New Jersey, United States