This is a single-center, open label, non-randomized metabolism, excretion, and mass balance study of a single IV infusion of \[14C\]-plazomicin in healthy, adult male subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
single intravenous dose
Clinical Site
Lincoln, Nebraska, United States
Sum of percent of total radioactivity recovered in urine and feces relative to the administered radioactive dose minus any radioactivity lost due to emesis
Time frame: 15 days
Total radioactivity concentration equivalents in plasma and blood
Time frame: 15 days
Plazomicin concentrations in plasma and urine
Time frame: 15 days
Incidence and severity of adverse events
Time frame: 21 days
Change from baseline in vital signs post dose (temperature, pulse, respiration, blood pressure)
Time frame: 1 day
Absolute values of and change from baseline in clinical laboratory values (hematology, serum chemistry, urine analysis)
Time frame: 4 days
Physical examination
Time frame: Screening
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