Pharmacokinetics and Safety of ALKS 5461 in Subjects With Renal Impairment and Normal Renal Function
- Registration Number
- NCT02508506
- Lead Sponsor
- Alkermes, Inc.
- Brief Summary
This study will evaluate the effect of various degrees of renal function on the pharmacokinetics and safety of ALKS 5461.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
For all subjects:
- Has a body mass index (BMI) of 18.0-40.0 kg/m^2 and a total body weight >50kg
- Agrees to use an approved method of contraception for the duration of the study
- Additional criteria may apply
For subjects with renal impairment:
- Has severe or end stage renal disease, and does not require dialysis
- Has stable renal function for at least 60 days preceding screening
- 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 renal impairment
- Has a history of gastrointestinal surgery affecting drug absorption or biliary elimination, 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 my apply
For subjects with renal impairment:
- Has evidence of compromised respiratory function, seizure disorder, or myasthenia gravis
- Has received a kidney transplant
- 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 measurable 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 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 Safety: Incidence of adverse events (SAE) Up to 12 days
Trial Locations
- Locations (2)
Alkermes Investigational SIte
🇺🇸Orlando, Florida, United States
Alkermes Investigational Site
🇺🇸Minneapolis, Minnesota, United States