Condition: EGFR Mutant Advanced Non-small Cell Lung Cancer · Central Nervous System (CNS) Metastases · Sponsor: Alpha Biopharma (Jiangsu) Co., Ltd.
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.
This description comes directly from the study's public registry record.
John Ge, M.D. · +86 (0)21-63862197 · john.ge@alphabiopharma.com.cn
Always discuss trial participation with your own doctor first.
| The First Affiliated Hospital of Soochow University | Suzhou, Jiangsu, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07620951