NCT06823232

A Study on the Substance Balance of [14C]XY0206 in Healthy Adult Chinese Men

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Shijiazhuang Yiling Pharmaceutical Co. Ltd · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this clinical trial is to quantitatively analyse the total radioactivity in the excreta of subjects after oral administration of \[14C\]XY0206, and to obtain data on human radioactive excretion rate and main excretion routes and the radioactivity of human plasma, urine, and faeces after oral administration of \[14C\]XY0206 by subjects Metabolite profiling, identification of major metabolites, determination of metabolic pathways and elimination pathways; Subjects who met the criteria fasted for at least 10h before administration and took \[14C\]XY0206 suspension (containing about 37.5mg/100µCi\[14C\]XY0206) orally on an empty stomach in the morning of the first day of administration (DI).Subjects will also complete urine, stool and blood collection within a specified period of time。

Conditions

• Metabolism of Radioactive Substances

Interventions

Type	Name	Description
DRUG	[14C]XY0206	On the morning of the day of medication (D1), the subject took \[14C\] XY0206 suspension orally on an empty stomach (containing approximately 37.5 mg/100 µ Ci \[14C\] XY0206).

Timeline

• Start date: 2024-11-06
• Primary completion: 2024-12-05
• Completion: 2024-12-05
• First posted: 2025-02-12
• Last updated: 2025-02-12

Locations

1 site across 1 country: China