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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Renal Impairment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ALKS 5461

Sublingual tablet

Group Type EXPERIMENTAL

ALKS 5461

Intervention Type DRUG

Single dose, given orally

Interventions

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ALKS 5461

Single dose, given orally

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes