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This study will characterize insulin sensitivity in response to treatment with ALKS 3831, olanzapine, and placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALKS 3831 | Experimental | Oral, bilayer tablet |
|
| Olanzapine | Active Comparator | Oral, bilayer tablet |
|
| Placebo | Placebo Comparator | Oral, bilayer tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALKS 3831 | Drug | Daily dosing for 21 consecutive days |
| |
| Olanzapine |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in blood glucose concentrations | Differences will be compared among treatment groups | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in insulin concentrations | Differences will be compared among treatment groups | 21 days |
| Incidence of treatment-emergent adverse events (AEs) | 24 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 | Chula Vista | California | 91911 | United States |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
Daily dosing for 21 consecutive days |
|
| Placebo | Drug | Daily dosing for 21 consecutive days |
|
| D006571 | Heterocyclic Compounds |