The study aims to evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of \[14C\]HRS-1780 following an oral single dose in healthy adult male participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
\[14C\]HRS-1780, oral.
Jinan Central Hospital, Affiliated to Shandong First Medical University
Jinan, Shandong, China
Total radioactivity ratio of whole blood/plasma.
Time frame: 0 to anticipated 11 days.
Tmax
Time to reach maximum concentration (Tmax).
Time frame: 0 to anticipated 11 days.
Cmax
Maximum concentration (Cmax).
Time frame: 0 to anticipated 11 days.
AUClast
Area under the concentration time curve from time point 0 to the last quantifiable time point (AUClast).
Time frame: 0 to anticipated 11 days.
AUC0-inf
Area under the concentration curve from time 0 to extrapolated infinite time (AUC0-inf).
Time frame: 0 to anticipated 11 days.
t1/2
Half-life (t1/2).
Time frame: 0 to anticipated 11 days.
CL/F
Apparent clearance (CL/F).
Time frame: 0 to anticipated 11 days.
Vz/F
Apparent volume of distribution (Vz/F).
Time frame: 0 to anticipated 11 days.
%AUC
Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC).
Time frame: 0 to anticipated 11 days.
%Dose
Percentage of parent drug and its metabolites in urine and feces as a percentage of administered dose (%Dose).
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Time frame: 0 to anticipated 11 days.
Total radioactivity ratio for blood/plasma.
Time frame: 0 to anticipated 11 days.
The cumulative recovery amount and recovery rate of total radioactive substances in urine and feces.
Time frame: 0 to anticipated 11 days.
Safety and tolerability as measured by incidence of adverse events (AEs) and serious AEs.
Time frame: 0 to anticipated 11 days.