NCT06654791

Mass Balance Clinical Trial of SIM0270

A Phase I Clinical Study to Evaluate the Mass Balance of [14C]SIM0270 in Healthy Chinese Adult Subjects

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, non-randomized, open-label, single-cohort, single-dose phase I clinical study in healthy Chinese adult male subjects.

Detailed description

The main objectives of this study were as follows: 1. To quantitatively analyze the total radioactivity in excreta of healthy subjects after a single oral administration of \[14C\]SIM0270, and to obtain the data of human radioactive excretion rate and main excretion routes. 2. After a single oral administration of \[14C\]SIM0270 in healthy subjects, radioactive metabolite profiles in plasma, urine and feces were investigated to identify metabolites, and the metabolic pathway, main metabolites and elimination pathway of SIM0270 in human body were determined. 3. The total radioactivity in whole blood and plasma of healthy subjects after a single oral administration of \[14C\]SIM0270 was quantitatively analyzed, the pharmacokinetic characteristics of total radioactivity in plasma were evaluated, and the distribution of total radioactivity in whole blood and plasma was investigated.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	[14C] SIM0270 Oral Preparation	Use according to the prescribed protocol

Timeline

• Start date: 2024-10-17
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2024-10-23
• Last updated: 2024-11-27

Locations

1 site across 1 country: China