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

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

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

Study Overview

• Status: Completed
• Conditions: Hepatic Impairment
• Intervention / Treatment: Drug: ALKS 5461

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32809
      • Alkermes Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 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 18.0-35.0 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

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	Up to 168 hours postdose
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	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

Outcome Measure	Time Frame
Incidence of adverse events (AEs)	Up to 14 weeks
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

Collaborators and Investigators

• Sponsor: Alkermes, Inc.
• Investigators: Study Director: Sanjeev Pathak, MD, Alkermes, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: May 21, 2015
• First Submitted That Met QC Criteria: May 21, 2015
• First Posted (Estimate): May 25, 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

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: ALK5461-215