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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Olanzapine/samidorphan 10 mg/10 mg |
|
| Group 2 | Experimental | Olanzapine/samidorphan 20 mg/10 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALKS 3831 | Drug | Oral capsule, daily administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | Up to 15 days of dosing | |
| Area under the concentration vs time curve over the 24 hour dosing interval (AUC0-24h) | Up to 15 days of dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Safety will be determined by incidence of drug-related adverse events | Up to 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David McDonnell, MD | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigational Site | Little Rock | Arkansas | 72205 | United States | ||
| Alkermes Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30348514 | Derived | Sun L, McDonnell D, von Moltke L. Pharmacokinetics and Short-term Safety of ALKS 3831, a Fixed-dose Combination of Olanzapine and Samidorphan, in Adult Subjects with Schizophrenia. Clin Ther. 2018 Nov;40(11):1845-1854.e2. doi: 10.1016/j.clinthera.2018.09.002. Epub 2018 Oct 20. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Clementon |
| New Jersey |
| 08021 |
| United States |
| Alkermes Investigational Site | Dayton | Ohio | 45417 | United States |