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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALKS 9072, Low dose | Experimental |
| |
| ALKS 9072, Med dose | Experimental |
| |
| ALKS 9072, High dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALKS 9072, Low dose | Drug | IM injection, given monthly |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration in plasma following last dose | 4 months | |
| Time to maximum concentration in plasma following last dose | 4 months | |
| Area under the plasma concentration time curve over the last dosing interval | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alkermes Medical Director, MD | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigational Site | Atlanta | Georgia | 30338 | United States | ||
| Alkermes Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28350572 | Result | Hard ML, Mills RJ, Sadler BM, Turncliff RZ, Citrome L. Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia. J Clin Psychopharmacol. 2017 Jun;37(3):289-295. doi: 10.1097/JCP.0000000000000691. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ALKS 9072, Med dose |
| Drug |
IM injection, given monthly |
|
| ALKS 9072, High dose | Drug | IM injection, given monthly |
|
| Placebo | Drug | Dosed matched placebo IM injection, given monthly |
|
| Hoffman Estates |
| Illinois |
| 60169 |
| United States |
| Alkermes Investigational Site | St Louis | Missouri | 63118 | United States |
| Alkermes Investigational Site | Willingboro | New Jersey | 08046 | United States |
| Alkermes Investigational Site | Philadelphia | Pennsylvania | 19139 | United States |
| Alkermes Investigational Site | Irving | Texas | 70562 | United States |