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

February 3, 2016 updated by: Alkermes, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80228
        • Alkermes Investigational Site
    • Florida
      • Orlando, Florida, United States, 32809
        • Alkermes Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Alkermes Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALKS 5461
Sublingual tablet
Drug: ALKS 5461
Single dose, given orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
up to 168 hours postdose
Maximum observed plasma concentration (CMAX) following a single dose of ALKS 5461
Time Frame: up to 168 hours postdose
up to 168 hours postdose

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alkermes, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 23, 2015

First Submitted That Met QC Criteria

July 23, 2015

First Posted (Estimate)

July 27, 2015

Study Record Updates

Last Update Posted (Estimate)

February 4, 2016

Last Update Submitted That Met QC Criteria

February 3, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALKS5461-A108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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