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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alkermes, Inc.

Criteria

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