Renal Impairment
Conditions
Keywords
ALKS 5461, Alkermes, Samidorphan, Renal Impairment, Pharmacokinetics, Buprenorphine
Brief summary
This study will evaluate the effect of various degrees of renal function on the pharmacokinetics and safety of ALKS 5461.
Interventions
DRUGALKS 5461
Single dose, given orally
Sponsors
Alkermes, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
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
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 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
| 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 |
| Safety: Incidence of adverse events (SAE) | Up to 12 days |
| 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