This study is a single-site, non randomized, open-label study to assess the absorption, metabolism, and excretion profile of \[14C\] HS-10504 in healthy adult male subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
\[¹⁴C\]HS-10504: Participants will receive a single oral administration of approximately 400 mg/200 μCi \[¹⁴C\]HS-10504 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 HS-10504 and its metabolites after single oral administration of \[14C\]HS-10504 in healthy adult male participants.
Time frame: All excreted urine and feces samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection.
Percentage of major metabolites in human plasma, urine, and feces.
To determine the metabolism and elimination pathways of HS-10504 after single oral administration of \[14C\]HS-10504 in healthy adult male subjects, and identify major metabolites.
Time frame: Plasma, urine and feces samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection.
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.
Time frame: Plasma samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection.
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.
Time frame: Urine and feces samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection.
total radioactivity in human plasma and whole blood (if applicable)
To evaluate total radioactivity in human plasma and whole blood (if applicable)
Time frame: From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.
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the concentration ratio of total radioactivity in whole blood to that in plasma at different time points.
the concentration ratio of total radioactivity in whole blood to that in plasma at different time points.
Time frame: From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.
Cmax
To evaluate the Cmax of HS-10504 and its metabolite M6-2 in plasma.
Time frame: From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.
Tmax
To evaluate the Tmax of HS-10504 and its metabolite M6-2 in plasma.
Time frame: From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.
AUC0-t
To evaluate the AUC0-t of HS-10504 and its metabolite M6-2 in plasma.
Time frame: From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.
AUC0-∞
To evaluate the AUC0-∞ of HS-10504 and its metabolite M6-2 in plasma.
Time frame: From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
To assess the safety and tolerability of a single oral dose of approximately \[14C\] HS-10504 in healthy adult male subjects
Time frame: Up to end of the study, approximately 3 months