This study will determine the safety, tolerability, and pharmacokinetics (PK) of olanzapine and samidorphan in adults with schizophrenia following 14 consecutive days of oral administration of ALKS 3831.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Oral capsule, daily administration
Alkermes Investigational Site
Little Rock, Arkansas, United States
Alkermes Investigational Site
Clementon, New Jersey, United States
Alkermes Investigational Site
Dayton, Ohio, United States
Maximum plasma concentration (Cmax)
Time frame: Up to 15 days of dosing
Area under the concentration vs time curve over the 24 hour dosing interval (AUC0-24h)
Time frame: Up to 15 days of dosing
Safety will be determined by incidence of drug-related adverse events
Time frame: Up to 21 days
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