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

Alkermes, Inc.2 sites in 1 country22 target enrollmentJuly 2015

ConditionsRenal Impairment

InterventionsALKS 5461

DrugsALKS 5461

Overview

Phase: Phase 1
Intervention: ALKS 5461
Conditions: Renal Impairment
Sponsor: Alkermes, Inc.
Enrollment: 22
Locations: 2
Primary Endpoint: Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-inf) following a single dose of ALKS 5461
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

July 2015

End Date

December 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Alkermes, Inc.

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

ALKS 5461

Sublingual tablet

Intervention: ALKS 5461

Outcomes

Primary Outcomes

Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-inf) following a single dose of ALKS 5461

Time Frame: up to 168 hours postdose

Area under the plasma concentration versus time curve from time 0 to time of last measurable concentration (AUC0-last) following a single dose of ALKS 5461

Time Frame: up to 168 hours postdose

Maximum observed plasma concentration (CMAX) following a single dose of ALKS 5461

Time Frame: up to 168 hours postdose