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

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

What this study is about