To evaluate the absorption, metabolism and excretion in healthy Chinese male subjects after a single oral dose of \[14C\]HMPL-306
* To quantitatively analyze the total radioactivity in excreta after oral administration of \[14C\]HMPL-306 in healthy subjects, obtain the data on human radioactivity excretion rate and determine the main excretion pathways; * To obtain the radioactive metabolite profile in plasma, urine, and feces after oral administration of \[14C\]HMPL-306 in healthy subjects, to identify the main metabolites and to determine the metabolism and elimination pathways; * To quantitatively analyze the total radioactivity in whole blood and plasma in healthy subjects after oral administration of \[14C\]HMPL-306, to obtain the pharmacokinetics of total radioactivity in plasma and to investigate the distribution of total radioactivity in whole blood and plasma;
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
6
D1: 250 mg/100 µCi \[14C\] HMPL-306 Single dose
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan, China
Human Mass Balance
Recovery and cumulative recovery of total radioactivity in excreta (urine and feces).
Time frame: Day1~Day29
Human Mass Balance
Percentage of the unchanged drug and its metabolites in plasma to total radioactivity exposure levels in plasma;
Time frame: Day-1~Day29
Human Mass Balance
Percentage of the unchanged drug and its metabolites in urine and feces to the administered dose;
Time frame: Day-1~Day29
Human Mass Balance
Identification of major metabolites in plasma, urine and feces.
Time frame: Day-1~Day29
Human Mass Balance
PK parameters of total radioactivity in the plasma; Ratio of total radioactivity concentration in whole blood/plasma at different time points.
Time frame: Day-1~Day29
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