This study will determine the pharmacokinetics (PK) of \[14c\]-samidorphan in healthy male volunteers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Single IV administration
Single sublingual administration containing radiolabel
Single oral administration containing radiolabel
Alkermes Investigational Site
Austin, Texas, United States
AUC 0-t
Area under the concentration time curve of total radioactivity from time 0 to last observed concentration in blood and plasma
Time frame: Up to 120 hours after each dose
Cmax
Maximum concentration of total radioactivity in blood and plasma
Time frame: Up to 120 hours after each dose
Tmax
Time to maximum concentration of total radioactivity in blood and plasma
Time frame: Up to 120 hours after each dose
Fe%0-t
Fraction of dose excreted in urine and feces
Time frame: Up to 120 hours after each dose
Safety and tolerability will be measured by the incidence of Adverse Events
Time frame: Up to 35 days
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