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

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

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Aripiprazole Lauroxil


Participation Criteria
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Eligibility Criteria
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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

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aripiprazole Lauroxil - A<br>Intramuscular (IM) injection Dose and Dosing Sequence A | Drug: Aripiprazole Lauroxil<br>* Gluteal IM injection, given once every 4 to 8 weeks<br>|
| Experimental: Aripiprazole Lauroxil - B<br>Intramuscular (IM) injection Dose and Dosing Sequence B | Drug: Aripiprazole Lauroxil<br>* Gluteal IM injection, given once every 4 to 8 weeks<br>|
| Experimental: Aripiprazole Lauroxil - C<br>Intramuscular (IM) injection Dose and Dosing Sequence C | Drug: Aripiprazole Lauroxil<br>* Gluteal IM injection, given once every 4 to 8 weeks<br>|
| Experimental: Aripiprazole Lauroxil - D<br>Intramuscular (IM) injection Dose and Dosing Sequence D | Drug: Aripiprazole Lauroxil<br>* Gluteal IM injection, given once every 4 to 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC 0-last | Area under the plasma-concentration time curve from time zero to the last quantifiable plasma concentration | Up to 45 weeks | 
| C max | Maximum plasma concentration | Up to 45 weeks | 
| T max | Time to maximum plasma concentration | Up to 45 weeks | 

Secondary Outcome Measures

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

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