This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of various doses and dosing intervals of aripiprazole lauroxil.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Gluteal IM injection, given once every 4 to 8 weeks
Alkermes Investigational Site
Little Rock, Arkansas, United States
Alkermes Investigational Site
Cerritos, California, United States
AUC 0-last
Area under the plasma-concentration time curve from time zero to the last quantifiable plasma concentration
Time frame: Up to 45 weeks
C max
Maximum plasma concentration
Time frame: Up to 45 weeks
T max
Time to maximum plasma concentration
Time frame: Up to 45 weeks
AUC 0-tau
Area under the plasma-concentration time curve over the dose interval
Time frame: Up to 45 weeks
Safety and tolerability will be measured by incidence of adverse events
Time frame: Up to 45 weeks
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Alkermes Investigational Site
Garden Grove, California, United States
Alkermes Investigational Site
Washington D.C., District of Columbia, United States
Alkermes Investigational Site
Lauderhill, Florida, United States
Alkermes Investigational Site
Leesburg, Florida, United States
Alkermes Investigational Site
Maitland, Florida, United States
Alkermes Investigational Site
Oakland Park, Florida, United States
Alkermes Investigational Site
Tampa, Florida, United States
Alkermes Investigational Site
Atlanta, Georgia, United States
...and 6 more locations