Pharmacokinetics and Safety of ALKS 5461 in Subjects With Renal Impairment and Normal Renal Function

• ALKS 5461 (Drug): Single dose, given orally

Primary outcomes

• 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]

Secondary outcomes

• 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) [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]

Sex: All, ages: 18 Years to 79 Years, accepts healthy volunteers

Inclusion Criteria:

For all subjects:

* Has a body mass index (BMI) of 18.0-40.0 kg/m\^2 and a total body weight >50kg
* Agrees to use an approved method of contraception for the duration of the study
* Additional criteria may apply

For subjects with renal impairment:

* Has severe or end stage renal disease, and does not require dialysis
* Has stable renal function for at least 60 days preceding screening
* Additional criteria may apply

Exclusion Criteria:

For all subjects:

* Has any past history or current finding of a clinically significant observed abnormality, psychiatric or medical condition other than renal impairment
* Has a history of gastrointestinal surgery affecting drug absorption or biliary elimination, excluding appendectomy or cholecystectomy
* Is pregnant, planning to become pregnant, or lactating
* Has a history of clinically significant allergy or a hypersensitivity to opioids
* Additional criteria my apply

For subjects with renal impairment:

* Has evidence of compromised respiratory function, seizure disorder, or myasthenia gravis
* Has received a kidney transplant
* Additional criteria may apply

• Arielle Stanford, MD, Study director, Alkermes, Inc.