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

NCT02452801 | Completed Phase 1

• 1 other identifier: ALK5461-215
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

• Incidence of adverse events (AEs)

  Up to 14 weeks

Study Arms (1)

ALKS 5461

EXPERIMENTAL

Sublingual tablet

Drug: ALKS 5461

Interventions

ALKS 5461 DRUG

Single dose, given orally

ALKS 5461

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (1)

Alkermes Investigational Site

Orlando, Florida, 32809, United States

Location

MeSH Terms

Interventions

ALKS 5461

Study Officials

• Sanjeev Pathak, MD

  Alkermes, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: May 25, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 4, 2016

Record last verified: 2016-02

Locations

US (1)