NCT05675202

Material Balance Study of TQ-B3525

Clinical Trial on Absorption, Metabolism and Excretion of [14C] TQ-B3525 in Chinese Adult Male Healthy Subjects - Research on Material Balance and Biotransformation of [14C] TQ-B3525

• 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

A clinical study to investigate the absorption, metabolism and excretion of \[14C\] TQ-B3525 in Chinese adult male healthy subjects, aiming to quantitatively analyze the total radioactivity in the excreta of male healthy subjects after oral administration of \[14C\] TQ-B3525, obtain the data of human radioactive excretion rate and main drainage routes, investigate the distribution in whole blood and plasma, the distribution in plasma and the pharmacokinetics of total radioactivity in plasma, and identify the main metabolites, To determine the main biotransformation pathway and obtain the pharmacokinetic parameters of TQ-B3525 and its metabolites in plasma.

Conditions

• Chronic Kidney Diseases
• Magnetic Resonance Imaging

Interventions

Type	Name	Description
DRUG	TQ-B3525	TQ-B3525 is a new PI3K α/δ Kinase inhibitor

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-08-01
• Completion: 2023-12-01
• First posted: 2023-01-09
• Last updated: 2023-01-12

Locations

1 site across 1 country: China