Material Balance of [14C]Zorifertinib in Healthy Adult Male Participants in China

This is a single-center, single-dose, open-label, Phase I study to evaluate the mass balance, biotransformation, pharmacokinetic characteristics, excretion pathways, and safety of a single oral 200 mg/5 µCi dose of \[14C\]Zorifertinib in healthy Chinese adult male participants. The study includes a screening period (Day -14 to Day -1) and a dosing and observation period (Day 1 to Day 14). Blood, urine, and feces samples will be collected to measure radioactivity, drug concentrations, and metabolites. Safety will be assessed by adverse events, vital signs, laboratory tests, 12-lead ECG, and ophthalmic examinations. The target total radioactivity recovery is ≥90% of the administered dose.

NCT Number	NCT07620951
Lead Sponsor	Alpha Biopharma (Jiangsu) Co., Ltd.
Conditions	EGFR Mutant Advanced Non-small Cell Lung Cancer, Central Nervous System (CNS) Metastases
Enrollment	8 participants
Start Date	2026-07-06
Primary Completion	2026-08 (estimated)
Study Completion	2026-08 (estimated)
Updated on ClinicalTrials.gov	2026-07-08