This study will evaluate the effect of various degrees of renal function on the pharmacokinetics and safety of ALKS 5461.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Single dose, given orally
Alkermes Investigational SIte
Denver, Colorado, United States
Alkermes Investigational SIte
Orlando, Florida, United States
Alkermes Investigational Site
Minneapolis, Minnesota, United States
Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-inf) following a single dose of ALKS 5461
Time frame: 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
Time frame: up to 168 hours postdose
Maximum observed plasma concentration (CMAX) following a single dose of ALKS 5461
Time frame: up to 168 hours postdose
Time to reach maximum plasma concentration (TMAX)
Time frame: up to 168 hours postdose
Terminal elimination half-life (T1/2)
Time frame: up to 168 hours postdose
Apparent clearance (CL/F)
Time frame: up to 168 hours postdose
Apparent volume of distribution (Vz/F)
Time frame: up to 168 hours postdose
Safety: Incidence of adverse events (SAE)
Time frame: Up to 12 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.