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

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: ALKS 5461

• Registration Number: NCT02508506
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-23
• Study First Submitted QC: 2015-07-23
• Study First Posted: 2015-07-27
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-03
• Last Update Posted: 2016-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALKS 5461	ALKS 5461	Sublingual tablet

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-inf) following a single dose of ALKS 5461	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	up to 168 hours postdose
Maximum observed plasma concentration (CMAX) following a single dose of ALKS 5461	up to 168 hours postdose

Secondary Outcome Measures

Name	Time	Method
Time to reach maximum plasma concentration (TMAX)	up to 168 hours postdose
Terminal elimination half-life (T1/2)	up to 168 hours postdose
Apparent clearance (CL/F)	up to 168 hours postdose
Apparent volume of distribution (Vz/F)	up to 168 hours postdose
Safety: Incidence of adverse events (SAE)	Up to 12 days

Trial Locations

Locations (2)

Alkermes Investigational SIte; 🇺🇸 Orlando, Florida, United States

Alkermes Investigational Site; 🇺🇸 Minneapolis, Minnesota, United States