NCT06438367

TGRX-326 Pharmacokinetic Mass Balance

Mass Balance Study of [14C]TGRX-326 in Healthy Adult Chinese Male Participants

• 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 TGRX-326 on mass balance to evaluate distribution, metabolism and excretion of TGRX-326, an ALK inhibitor indicated for treatment of Non-small cell lung cancer.

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-326 using the Carbon-14 labelled isotope of TGRX-326 compound. Safety evaluation will also be conducted.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	[14C]TGRX-326	Healthy subjects will be given TGRX-326 60 mg orally on day 1.

Timeline

• Start date: 2024-06-26
• Primary completion: 2024-07-08
• Completion: 2024-07-21
• First posted: 2024-05-31
• Last updated: 2025-02-21

Locations

1 site across 1 country: China