Schizophrenia
Conditions
Keywords
Alkermes, Schizophrenia, Aripiprazole, Aripiprazole lauroxil, ALKS 9072
Brief summary
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of various doses and dosing intervals of aripiprazole lauroxil.
Interventions
Gluteal IM injection, given once every 4 to 8 weeks
Sponsors
Alkermes, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC 0-last | Up to 45 weeks | Area under the plasma-concentration time curve from time zero to the last quantifiable plasma concentration |
| C max | Up to 45 weeks | Maximum plasma concentration |
| T max | Up to 45 weeks | Time to maximum plasma concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC 0-tau | Up to 45 weeks | Area under the plasma-concentration time curve over the dose interval |
| Safety and tolerability will be measured by incidence of adverse events | Up to 45 weeks | — |
Countries
United States
Outcome results
None listed