NCT06149611

Mass Balance Study of TQB3616

Clinical Study on Material Balance of [14C]TQB3616 in Healthy Chinese Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a clinical study exploring the mass balance of \[14C\] TQB3616 in healthy Chinese subjects aims to quantitatively analyze the total radioactivity in the feces of male healthy subjects after oral administration of \[14C\] TQB3616, obtain data on human radiation excretion rate and main excretion pathways, investigate the distribution in whole blood and plasma, plasma distribution, and pharmacokinetics of total radioactivity in plasma, identify main metabolites, and determine the main biological transformation pathways, obtain the pharmacokinetic parameters of TQB3616 and its metabolites in plasma. The primary endpoint is mass balance, radiopharmacokinetics, plasma pharmacokinetics, and metabolites.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	[14C] TQB3616	TQB3616 is a new type of cyclin-dependent kinase (CDK) 4/6 inhibitor.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2023-11-29
• Last updated: 2023-11-29

Locations

1 site across 1 country: China