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

A Phase 1 Study of the Pharmacokinetics, Safety, and Tolerability of ALKS5461 in Subjects With Renal Impairment

This study will evaluate the effect of various degrees of renal function on the pharmacokinetics and safety of ALKS 5461.

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