Pharmacokinetics and Safety of ALKS 5461 in Healthy Subjects and Subjects With Hepatic Impairment and Normal Hepatic Function
- 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
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
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
- 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 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 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which ALKS 5461 modulates hepatic function in patients with hepatic impairment?
How does the pharmacokinetic profile of ALKS 5461 compare to other opioid antagonists in subjects with varying degrees of hepatic impairment?
Are there specific biomarkers that correlate with improved safety or efficacy outcomes of ALKS 5461 in hepatic impairment populations?
What adverse events are associated with ALKS 5461 in phase 1 trials involving hepatically impaired subjects, and how are they managed?
What is the therapeutic potential of ALKS 5461 in combination with other agents for managing hepatic impairment-related conditions?
Trial Locations
- Locations (1)
Alkermes Investigational Site
🇺🇸Orlando, Florida, United States
Alkermes Investigational Site🇺🇸Orlando, Florida, United States