This study will determine the pharmacokinetics (PK), safety, and tolerability of ALKS 9072 (also known as ALKS 9070) after 4 monthly doses in adults with chronic stable schizophrenia.
Three active treatment groups and a placebo group are planned. Randomization will be sequential by dose level across the sites with placebo assignments randomly inserted. Each subject's participation will be approximately 8 months, including screening, treatment period, and a 3-month follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
88
IM injection, given monthly
IM injection, given monthly
IM injection, given monthly
Alkermes Investigational Site
Atlanta, Georgia, United States
Alkermes Investigational Site
Hoffman Estates, Illinois, United States
Alkermes Investigational Site
St Louis, Missouri, United States
Alkermes Investigational Site
Willingboro, New Jersey, United States
Maximum concentration in plasma following last dose
Time frame: 4 months
Time to maximum concentration in plasma following last dose
Time frame: 4 months
Area under the plasma concentration time curve over the last dosing interval
Time frame: 4 months
Number of Participants with Adverse Events
Time frame: 4 months
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Dosed matched placebo IM injection, given monthly
Alkermes Investigational Site
Philadelphia, Pennsylvania, United States
Alkermes Investigational Site
Irving, Texas, United States