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

Hepatic Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02452801
• Other study ID #: ALK5461-215
• Status: Completed
• Phase: Phase 1
• First received: May 21, 2015
• Last updated: February 3, 2016
• Start date: May 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• ALKS 5461
Single dose, given orally

Locations

Country	Name	City	State
United States	Alkermes Investigational Site	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Maximum observed plasma concentration (CMAX) following a single dose of ALKS 5461		Up to 168 hours postdose	No
Secondary	Time to reach maximum plasma concentration (TMAX)		Up to 168 hours postdose	No
Secondary	Terminal elimination half-life (T1/2)		Up to 168 hours postdose	No
Secondary	Apparent clearance (CL/F)		Up to 168 hours postdose	No
Secondary	Apparent volume of distribution (Vz/F)		Up to 168 hours postdose	No
Secondary	Incidence of adverse events (AEs)		Up to 14 weeks	Yes