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

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

Official Title
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A Phase 1, Randomized, Open-label, Single Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aripiprazole Lauroxil Following Administration to the Deltoid or Gluteal Muscle in Adults With Schizophrenia or Schizoaffective Disorder

Conditions
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Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Drug: Aripiprazole Lauroxil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Location<br>Deltoid or Gluteal Muscle | Drug: Aripiprazole Lauroxil<br>* Intramuscular (IM) injection, single dose<br>* Other names: ARISTADA TM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) |  | Up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Schizoaffective Disorder, Aripiprazole Lauroxil, Aripiprazole, ALKS 9072, Alkermes