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

Completed · Phase 1

Conditions studied: Renal Impairment

In brief

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

Key facts

Study ID

NCT02508506

Run by

Alkermes, Inc.

People needed

22

Starts

2015-07-01

Expected to finish

2015-12-01

Last updated by the study team

2016-02-04

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alkermes Investigational SIte — Denver, Colorado, United States
• Alkermes Investigational SIte — Orlando, Florida, United States
• Alkermes Investigational Site — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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