This study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of \[14C\]RAY1216 in healthy Chinese male participants, revealing the overall pharmacokinetic characteristics of RAY1216.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
6
400 mg suspension containing 100μCi of \[14C\]RAY1216
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
Total radioactivity in plasma PK
Cmax
Time frame: Up to 7 days from the start of administration.
Total radioactivity in plasma PK
AUC0-t
Time frame: Up to 7 days from the start of administration.
Total radioactivity in plasma PK
CL/F
Time frame: Up to 7 days from the start of administration.
Total radioactivity in plasma PK
Vz/F
Time frame: Up to 7 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 14 days (approx) from the start of administration.
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