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

Alkermes

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: ALKS 5461

Study type: Interventional

Funder types: Industry

Identifiers

NCT02508506

ALKS5461-A108

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

ALKS 5461

Experimental group

Description:

Sublingual tablet

Treatment:

Drug: ALKS 5461