NCT06986772

TGRX-678 Pharmacokinetic Mass Balance

[14C]TGRX-678 Mass Balance Study in Chinese Healthy Male Adults

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

Summary

This is a pharmacokinetic study for \[14C\]TGRX-678 on mass balance to evaluate distribution, metabolism and excretion of TGRX-678, a tyrosine kinase inhibitor indicated for treatment of chronic myeloid leukemia.

Detailed description

This study is designed as a single-center, single-dose, non-randomized and open-label study. The study will be conducted in healthy male participants to evaluate distribution, metabolic pathways and route of excretion of TGRX-678 using the Carbon-14 labelled isotope of TGRX-678 compound. Safety and pharmacokinetic evaluation will also be conducted.

Conditions

• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	[14C]TGRX-678	Healthy subjects will be given TGRX-678 240 mg orally on day 1.

Timeline

• Start date: 2025-07-07
• Primary completion: 2025-08-17
• Completion: 2025-08-25
• First posted: 2025-05-23
• Last updated: 2025-09-04

Locations

1 site across 1 country: China