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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02452801

Enrollment

Registered

2015-05-25

Start date

2015-05-31

Completion date

2015-12-31

Last updated

2016-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Impairment

Brief summary

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

Interventions

DRUGALKS 5461

Single dose, given orally

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Measure	Time frame
Apparent volume of distribution (Vz/F)	Up to 168 hours postdose
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026