A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 7/15/2016 |
| Start Date: | December 2015 |
| End Date: | June 2016 |
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
The study will determine the safety, tolerability, and pharmacokinetics of aripiprazole
lauroxil in adults with schizophrenia or schizoaffective disorder.
lauroxil in adults with schizophrenia or schizoaffective disorder.
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
We found this trial at
6
sites
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