Back to results

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

Primary Purpose

Hepatic Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ALKS 5461

About this trial

This is an interventional treatment trial for Hepatic Impairment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

For all subjects:

Has a body mass index (BMI) of 18.0-35.0 kg/m2 and a total body weight >50 kg
Agrees to use an approved method of contraception for the duration of the study
Additional criteria may apply

For subjects with hepatic impairment:

Has mild, moderate, or severe hepatic impairment
Has hepatic dysfunction due to hepatocellular disease
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 hepatic impairment
Has a history of gastrointestinal surgery, 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 may apply

For subjects with hepatic impairment:

Has evidence of hepatocellular carcinoma, acute liver disease, biliary obstruction, severe ascites, severe portal hypertension, surgical systemic shunts, or other clinically relevant liver-related disorder or condition
Has received a liver transplant
Has had esophageal variceal bleeding in the past 2 months
Additional criteria may apply

Sites / Locations

Alkermes Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ALKS 5461

Arm Description

Sublingual tablet

Outcomes

Primary Outcome Measures

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

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

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

Secondary Outcome Measures

Time to reach maximum plasma concentration (TMAX)

Terminal elimination half-life (T1/2)

Apparent clearance (CL/F)

Apparent volume of distribution (Vz/F)

Incidence of adverse events (AEs)

Full Information

NCT ID

NCT02452801

First Posted

May 21, 2015

Last Updated

February 3, 2016

Sponsor

Alkermes, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02452801

Brief Title

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

Official Title

A Phase 1 Study of the Pharmacokinetics, Safety, and Tolerability of ALKS 5461 in Subjects With Hepatic Impairment

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

May 2015 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alkermes, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ALKS 5461

Arm Type

Experimental

Arm Description

Sublingual tablet

Intervention Type

Drug

Intervention Name(s)

ALKS 5461

Intervention Description

Single dose, given orally

Primary Outcome Measure Information:

Title

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

Title

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

Time Frame

Up to 168 hours postdose

Title

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

Time Frame

Up to 168 hours postdose

Secondary Outcome Measure Information:

Title

Time to reach maximum plasma concentration (TMAX)

Time Frame

Up to 168 hours postdose

Title

Terminal elimination half-life (T1/2)

Time Frame

Up to 168 hours postdose

Title

Apparent clearance (CL/F)

Time Frame

Up to 168 hours postdose

Title

Apparent volume of distribution (Vz/F)

Time Frame

Up to 168 hours postdose

Title

Incidence of adverse events (AEs)

Time Frame

Up to 14 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: For all subjects: Has a body mass index (BMI) of 18.0-35.0 kg/m2 and a total body weight >50 kg Agrees to use an approved method of contraception for the duration of the study Additional criteria may apply For subjects with hepatic impairment: Has mild, moderate, or severe hepatic impairment Has hepatic dysfunction due to hepatocellular disease 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 hepatic impairment Has a history of gastrointestinal surgery, 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 may apply For subjects with hepatic impairment: Has evidence of hepatocellular carcinoma, acute liver disease, biliary obstruction, severe ascites, severe portal hypertension, surgical systemic shunts, or other clinically relevant liver-related disorder or condition Has received a liver transplant Has had esophageal variceal bleeding in the past 2 months Additional criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sanjeev Pathak, MD

Organizational Affiliation

Alkermes, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Alkermes Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs