NCT07211165

Clinical Study on the Mass Balance of Clifutinib

Study on the Mass Balance of [14C] Clifutinib in Chinese Male Healthy Subjects

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

Summary

To investigate the plasma total radioactivity PK characteristics of male healthy subjects after a single oral administration of \[14C\]Clifutinib, the distribution of total radioactivity in whole blood and plasma, and to determine the main excretion and metabolic pathways.

Conditions

• Healthy Adult Male

Interventions

Type	Name	Description
DRUG	[14C]Clifutinib	The subjects are required to take the test drug on an empty stomach for at least 10 hours and without drinking water for 1 hour. After taking the drug, they should fast for 4 hours and refrain from drinking water for 1 hour.

Timeline

• Start date: 2025-09-29
• Primary completion: 2025-11-05
• Completion: 2025-11-12
• First posted: 2025-10-07
• Last updated: 2026-01-16

Locations

1 site across 1 country: China