This is an open-label, single center, 1-period study in healthy adult male subjects to assess absorption, metabolism, and excretion of HMS5552 after a single oral administration of 50 mg (90 μCi) of \[14C\]-HMS5552.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
\[14C\]-labelled HMS5552
Celerion
Lincoln, Nebraska, United States
Total radioactivity in blood, plasma urine and feces
Peak plasma concentration (Cmax)
Time frame: Up to 168 hours
Total radioactivity in blood, plasma urine and feces
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to 168 hours
Total radioactivity in blood, plasma urine and feces
Time to reach Cmax (Tmax)
Time frame: Up to 168 hours
Total radioactivity in blood, plasma urine and feces
Total radioactivity in urine and faeces at each time interval and cumulative radioactivity (mass balance)
Time frame: Up to 168 hours
Concentrations of HMS5552 and its metabolites in plasma, urine and feces
Peak plasma concentration (Cmax)
Time frame: Up to 168 hours
Number of participants with adverse events as a measure of safety and tolerability
Adverse events; Laboratory parameters; Vital signs, clinical signs and symptoms and physical examination, including changes from baseline; ECG evaluation
Time frame: Up to 168 hours
Concentrations of HMS5552 and its metabolites in plasma, urine and feces
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to 168 hours
Concentrations of HMS5552 and its metabolites in plasma, urine and feces
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Time to reach Cmax (Tmax)
Time frame: Up to 168 hours