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



Status:Completed
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:8/31/2018
Start Date:December 2014
End Date:April 2016

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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

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


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
We found this trial at
16
sites
Little Rock, Arkansas 72211
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Little Rock, AR
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Atlanta, Georgia 30308
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Atlanta, GA
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Austin, Texas 78731
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Austin, TX
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Cerritos, California 90703
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Cerritos, CA
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Chicago, Illinois 60611
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Chicago, IL
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Dallas, Texas 75231
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Dallas, TX
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Garden Grove, California 92845
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Garden Grove, CA
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Hoffman Estates, Illinois 60169
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Hoffman Estates, IL
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Lauderhill, Florida 33161
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Lauderhill, FL
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Leesburg, Florida 34748
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Leesburg, FL
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Maitland, Florida 32751
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Maitland, FL
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Marlton, New Jersey 08053
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Marlton, NJ
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Oakland Park, Florida 33334
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Oakland Park, FL
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Saint Louis, Missouri 63104
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Saint Louis, MO
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Tampa, FL
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Washington, District of Columbia 20016
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Washington,
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