This is a single-center, nonrandomized, and open design study to investigate the pharmacokinetics, mass balance, metabolism and excretion of HSK31858 in healthy male subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
A single oral dose of 40 mg/120 μCi \[14C\]HSK31858 after fasting for at least 10 hours.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Total radioactivity ecovery rates in urine
Total radioactivity ecovery rates in urine at each time interval.
Time frame: during periods of 0-4 hours, 4-8 hours, 8-12 hours, 12-24 hours, 24-48 hours, 48-72 hours, 72-96 hours, 96-120 hours, 120-144 hours, 144-168 hours, 168-192 hours, 192-216 hours, 216-240 hours, 240-264 hours, 264-288 hours, and 288-312 hours post-dose
Total radioactivity ecovery rates in feces
Total radioactivity ecovery rates in feces at each time interval.
Time frame: during periods of 0-24 hours, 24-48 hours, 48-72 hours, 72-96 hours, 96-120 hours, 120-144 hours, 144-168 hours, 168-192 hours, 192-216 hours, 216-240 hours, 240-264 hours, 264-288 hours, and 288-312 hours post-dose
Cumulative total radioactivity recovery rates
Cumulative total radioactivity recovery rates of \[14C\]HSK31858 in excretion (urine and faeces) accounting for total radiation drug dose.
Time frame: From the start of administration to 312 hours post-dose
Cmax of total radioactivity
The pharmacokinetic parameters of total radioactivity in plasma
Time frame: From the start of administration to 312 hours post-dose
AUC(0-t) of total radioactivity
The pharmacokinetic parameters of total radioactivity in plasm
Time frame: From the start of administration to 312 hours post-dose
AUC(0-∞) of total radioactivity
The pharmacokinetic parameters of total radioactivity in plasm
Time frame: From the start of administration to 312 hours post-dose
%AUC
Human plasma parent drug and its metabolites as a percentage of total plasma radioactivity exposure
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Time frame: From the start of administration to 312 hours post-dose
% administered dose
Human urine and feces parent drug and its metabolites as a percentage of administered dose
Time frame: From the start of administration to 312 hours post-dose
Identification of the main metabolites
Identification of the main metabolites of HSK31858 in plasma, urine, and feces.
Time frame: From the start of administration to 312 hours post-dose
AUC(0-t)
The pharmacokinetic parameters of the parent drug HSK31858, metabolite M4 and other metabolites (if applicable) in plasma
Time frame: From the start of administration to 312 hours post-dose
AUC(0-∞)
The pharmacokinetic parameters of the parent drug HSK31858, metabolite M4 and other metabolites (if applicable) in plasma
Time frame: From the start of administration to 312 hours post-dose
Cmax
The pharmacokinetic parameters of the parent drug HSK31858, metabolite M4 and other metabolites (if applicable) in plasma
Time frame: From the start of administration to 312 hours post-dose
Tmax
The pharmacokinetic parameters of the parent drug HSK31858, metabolite M4 and other metabolites (if applicable) in plasma
Time frame: From the start of administration to 312 hours post-dose
t1/2
The pharmacokinetic parameters of the parent drug HSK31858, metabolite M4 and other metabolites (if applicable) in plasma
Time frame: From the start of administration to 312 hours post-dose
Mean Residence Time
The pharmacokinetic parameters of the parent drug HSK31858, metabolite M4 and other metabolites (if applicable) in plasma
Time frame: From the start of administration to 312 hours post-dose
AEs
The incidence and severity of AEs
Time frame: From the time of signing ICF to the end of follow-up,up to 14 days.