NCT05720091

Substance Balance Study of [14C]ZX-7101A in Healthy Adult Male Subjects in China

A Study to Evaluate the Substance Balance of [14C] ZX-7101A in Healthy Adult Male Subjects in China

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Nanjing Zenshine Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
DRUG	ZX-7101A 80mg	a drug to treatment influenza in Chinese adults

Timeline

• Start date: 2023-02-14
• Primary completion: 2023-03-20
• Completion: 2023-07-25
• First posted: 2023-02-09
• Last updated: 2024-11-05

Locations

1 site across 1 country: China