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This study will evaluate the effect of various degrees of hepatic function on the pharmacokinetics and safety of ALKS 5461.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALKS 5461 | Experimental | Sublingual tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALKS 5461 | Drug | Single dose, given orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-inf) following a single dose of ALKS 5461 | Up to 168 hours postdose | |
| Area under the plasma concentration versus time curve from time 0 to time of last measureable concentration (AUC0-last) following a single dose of ALKS 5461 | Up to 168 hours postdose | |
| Maximum observed plasma concentration (CMAX) following a single dose of ALKS 5461 | Up to 168 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach maximum plasma concentration (TMAX) | Up to 168 hours postdose | |
| Terminal elimination half-life (T1/2) | Up to 168 hours postdose | |
| Apparent clearance (CL/F) |
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Inclusion Criteria:
For all subjects:
For subjects with hepatic impairment:
Exclusion Criteria:
For all subjects:
For subjects with hepatic impairment:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjeev Pathak, MD | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigational Site | Orlando | Florida | 32809 | United States |
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| ID | Term |
|---|---|
| C000618349 | ALKS 5461 |
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| Up to 168 hours postdose |
| Apparent volume of distribution (Vz/F) | Up to 168 hours postdose |
| Incidence of adverse events (AEs) | Up to 14 weeks |