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

Phase 1

Completed

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

• Registration Number: NCT02452801
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-21
• Study First Submitted QC: 2015-05-21
• Study First Posted: 2015-05-25
• 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: 40

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

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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

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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 time of last measureable concentration (AUC0-last) following a single dose of ALKS 5461	Up to 168 hours postdose
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
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
Incidence of adverse events (AEs)	Up to 14 weeks
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

Trial Locations

Locations (1)

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