This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single dose of \[14C\]AR882 in healthy adult male subjects. Whole blood, plasma, urine, and fecal samples will be analyzed for at least 144 hours following the single dose of AR882 to measure total radioactivity and plasma drug concentrations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Single dose of \[14C\]AR882
Celerion, Inc.
Lincoln, Nebraska, United States
Total radioactivity (TRA) in urine
Time frame: Days 1-14
TRA in feces
Time frame: Days 1-14
TRA concentration equivalents in plasma
Time frame: Days 1-14
TRA concentration equivalents in whole blood
Time frame: Days 1-14
Area under the curve (AUC) for plasma [14C]-AR882
Profile from plasma in terms of AUC following a single dose of \[14C\]-AR882
Time frame: 7 Days
Time to maximum plasma concentration (Tmax) for [14C]-AR882
Profile from plasma in terms of Tmax following a single dose of \[14C\]-AR882
Time frame: 7 Days
Maximum plasma concentration (Cmax) for [14C]-AR882
Profile from plasma in terms of Cmax following a single dose of \[14C\]-AR882
Time frame: 7 Days
Apparent terminal half-life (t1/2) for [14C]-AR882
Profile from plasma in terms of t1/2 following a single dose of \[14C\]-AR882
Time frame: 7 Days
Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs [14C]-AR882
Time frame: Days 1-14
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