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This study will evaluate the impact of Itraconazole on the pharmacokinetics of ALKS 5461.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Itraconazole | Other | Itraconazole or placebo |
|
| ALKS 5461 | Experimental | ALKS 5461 or placebo Sublingual tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itraconazole | Drug | Administered orally in a crossover design |
|
| Measure | Description | Time Frame |
|---|---|---|
| Drug-Drug Interaction - AUC0-t | Area under the concentration time curve from time zero to the last measureable time point (AUC0-t) of ALKS 5461 in the presence and absence of itraconazole | Up to 48 hours |
| Drug-Drug Interaction - AUC0-inf | Area under the concentration time curve from time zero to infinity (AUC0-inf) of ALKS 5461 in the presence and absence of itraconazole | Up to 48 hours |
| Drug-Drug Interaction - Cmax | Maximum plasma concentration (Cmax) of ALKS 5461 in the presence and absence of itraconazole | Up to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability will be measured by incidence of adverse events | Up to 32 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjeev Pathak, MD | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigational Site | Overland Park | Kansas | 66212 | United States |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| C000618349 | ALKS 5461 |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| ALKS 5461 | Drug | Administered sublingually in a crossover design |
|
|
| D010879 |
| Piperazines |