Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the effect of various degrees of renal function on the pharmacokinetics and safety of ALKS 5461.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 measurable 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) |
Not provided
Inclusion Criteria:
For all subjects:
For subjects with renal impairment:
Exclusion Criteria:
For all subjects:
For subjects with renal impairment:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Arielle Stanford, MD | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigational SIte | Denver | Colorado | 80228 | United States | ||
| Alkermes Investigational SIte |
Not provided
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| C000618349 | ALKS 5461 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| up to 168 hours postdose |
| Apparent volume of distribution (Vz/F) | up to 168 hours postdose |
| Safety: Incidence of adverse events (SAE) | Up to 12 days |
| Orlando |
| Florida |
| 32809 |
| United States |
| Alkermes Investigational Site | Minneapolis | Minnesota | 55404 | United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |