A Single-center, Non-randomized, Open-label, Single-dose Mass Balance Study of \[14C\]FXS4640 in Healthy Adult Male Participants
Healthy adult Chinese males;
Age at the time of signing the informed consent form (ICF): 18-45 years old (inclusive);
Body mass index (BMI) range of 19.0-26.0 kg/m² (inclusive), and body weight not less than 50 kg;
No plan to father a child or donate sperm within 6 months after the last dose, and voluntarily take strict contraceptive measures (see Appendix 1 for details);
None
Single group
[¹⁴C]FXS4640
DrugParticipants will receive a single oral administration of approximately 30 mg/200 μCi \[¹⁴C\]FXS4640 under fasting conditions on day 1 morning
Total radiorecovery and cumulative radiorecovery in urine and feces per time interval
To assess the routes and rates of elimination of FXS4640 and its metabolites after single oral administration of \[14C\]FXS4640 in healthy adult male participants.
The percentage of plasma total radioactivity exposure accounted for by the parent compound and its metabolites (%AUC)
To evaluate the percentage of plasma total radioactivity exposure accounted for by the parent compound and its metabolites
The percentage of the administered dose recovered as parent drug and metabolites in urine and feces
To evaluate the percentage of the administered dose recovered as parent drug and metabolites in urine and feces, Identification of major metabolites in human urine and feces.
total radioactivity in human plasma and whole blood (if applicable)
To evaluate total radioactivity in human plasma and whole blood (if applicable) ,
the concentration ratio of total radioactivity in whole blood to that in plasma at different time points
To evaluate the concentration ratio of total radioactivity in whole blood to that in plasma at different time points
Cmax
To evaluate the Cmax of FXS4640 and its metabolite(if applicable) in plasma.
Tmax
To evaluate the Tmax of FXS4640 and its metabolite(if applicable) in plasma.
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