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

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