Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
Schizophrenia, Schizoaffective Disorder, Aripiprazole Lauroxil, Aripiprazole, ALKS 9072, Alkermes
Brief summary
The study will determine the safety, tolerability, and pharmacokinetics of aripiprazole lauroxil in adults with schizophrenia or schizoaffective disorder.
Interventions
Intramuscular (IM) injection, single dose
Sponsors
Alkermes, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration (Cmax) | Up to 7 days |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed