Substance Balance Study of [14C]ZX-7101A in Healthy Adult Male Subjects in China
Status:
Not yet recruiting
Trial end date:
2023-07-08
Target enrollment:
Participant gender:
Summary
The objectives of this substance balance study in healthy Chinese adult male subjects are to
obtain human radioactivity recovery data and major excretion pathways, and to obtain
pharmacokinetics of total radioactivity in plasma, and to identify major metabolites in the
radiometabolite spectrum. The main questions it aims to answer are:
- Quantitative analysis of total fecal and urine radioactivity in healthy subjects after
oral administration of [14C]ZX-7101A to obtain human radioactive recovery data and main
excretion routes.
- Pharmacokinetics of total activity in whole blood and plasma, and distribution of total
activity in whole blood and plasma are quantitatively analyzed after oral administration
of [14C]ZX-7101A in healthy subjects.
- Quantitative analysis of the radioactive metabolites in plasma, urine and feces of
healthy subjects with once [14C]ZX-7101A orally administration, identification of the
main metabolites of the radioactive metabolites (close to or greater than 10% of the
total radioactive AUC in plasma), and determination of the main biotransformation and
elimination pathway of ZX-7101A.