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

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Aripiprazole Lauroxil

• Registration Number: NCT02320032
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-16
• Study First Submitted QC: 2014-12-16
• Study First Posted: 2014-12-19
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aripiprazole Lauroxil - C	Aripiprazole Lauroxil	Intramuscular (IM) injection Dose and Dosing Sequence C
Aripiprazole Lauroxil - D	Aripiprazole Lauroxil	Intramuscular (IM) injection Dose and Dosing Sequence D
Aripiprazole Lauroxil - A	Aripiprazole Lauroxil	Intramuscular (IM) injection Dose and Dosing Sequence A
Aripiprazole Lauroxil - B	Aripiprazole Lauroxil	Intramuscular (IM) injection Dose and Dosing Sequence B

Primary Outcome Measures

Name	Time	Method
T max	Up to 45 weeks	Time to maximum plasma concentration
AUC 0-last	Up to 45 weeks	Area under the plasma-concentration time curve from time zero to the last quantifiable plasma concentration
C max	Up to 45 weeks	Maximum plasma concentration

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability will be measured by incidence of adverse events	Up to 45 weeks
AUC 0-tau	Up to 45 weeks	Area under the plasma-concentration time curve over the dose interval

Trial Locations

Locations (1)

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