Clinical trial NCT02452801: Pharmacokinetics and Safety of ALKS 5461 in Healthy Subjects and Subjects With Hepatic Impairment and Normal Hepatic Function
Official title: A Phase 1 Study of the Pharmacokinetics, Safety, and Tolerability of ALKS 5461 in Subjects With Hepatic Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-inf) following a single dose of ALKS 5461
timeFrame: Up to 168 hours postdose
measure: 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
timeFrame: Up to 168 hours postdose
measure: Maximum observed plasma concentration (CMAX) following a single dose of ALKS 5461
timeFrame: Up to 168 hours postdose
Secondary outcomes:
measure: Time to reach maximum plasma concentration (TMAX)
timeFrame: Up to 168 hours postdose
measure: Terminal elimination half-life (T1/2)
timeFrame: Up to 168 hours postdose
measure: Apparent clearance (CL/F)
timeFrame: Up to 168 hours postdose
measure: Apparent volume of distribution (Vz/F)
timeFrame: Up to 168 hours postdose
measure: Incidence of adverse events (AEs)
timeFrame: Up to 14 weeks
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Alkermes Investigational Site
state: Florida
Study officials:
affiliation: Alkermes, Inc.
name: Sanjeev Pathak, MD
role: STUDY_DIRECTOR
References: