This study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of \[14C\]ZSP1273 in healthy Chinese male participants, revealing the overall pharmacokinetic characteristics of ZSP1273.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
6
600 mg suspension containing 50μCi of \[14C\]ZSP1273
The First affiliated hospital of Suzhou university
Suzhou, China
Total radioactivity in plasma PK: Cmax
Time frame: Up to 14 days from the start of administration.
Total radioactivity in plasma PK: AUC0-t
Time frame: Up to 14 days from the start of administration.
Total radioactivity in plasma PK: CL/F
Time frame: Up to 14 days from the start of administration.
Total radioactivity in plasma PK: Vz/F
Time frame: Up to 14 days from the start of administration.
Mass balance recovery of total radioactivity in all (urine, faeces) amount excreted (Ae) expressed as a percentage of the administered dose (%Ae)
Time frame: Up to 14 days from the start of administration.
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: Up to 23 days (approx) from the start of administration.
Quantitive analysis of the concentrations of ZSP1273 and its major metabolites(if applicable) in plasma using the validated LC-MS/MS to obtain pharmacokinetic data.
Time frame: Up to 14 days from the start of administration.
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