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Life sciences · Phase 1 Trial
ClinicalTrials.gov · September 22, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07620951). This is a study registration, not published results. Lead sponsor: Alpha Biopharma (Jiangsu) Co., Ltd.. Recruitment status: COMPLETED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 6 participants (ACTUAL). Conditions: EGFR Mutant Advanced Non-small Cell Lung Cancer, Central Nervous System (CNS) Metastases. Interventions: DRUG: [14C]Zorifertinib Oral Formulation. Primary outcome measures: Total radioactive recovery and cumulative total radioactive recovery in urine and feces at each time interval , Pre-dose up to 312 hours after dosing, or until termination criteria met; Percentage of total radioactivity exposure (%AUC), percentage of parent drug and its metabolites (%Dose), and metabolite identification , Pre-dose up to 312 hours after dosing, or until termination criteria met; Peak Plasma Concentration (Cmax) , Pre-dose up to 120 hours after dosing,or until termination criteria met; Time to Peak Concentration (Tmax) , Pre-dose up to 120 hours after dosing,or until termination criteria met; Area under the plasma concentration versus time curve (AUC) , Pre-dose up to 120 hours after dosing,or until termination criteria met; Elimination Half-Life (t1/2) , Pre-dose up to 120 hours after dosing,or until termination criteria met; Terminal Rate Constant (λz) , Pre-dose up to 120 hours after dosing,or until termination criteria met; Apparent Volume of Distribution (Vz/F) , Pre-dose up to 120 hours after dosing,or until termination criteria met; Apparent Clearance (CLz/F) , Pre-dose up to 120 hours after dosing,or until termination criteria met; Mean Residence Time (MRT) , Pre-dose up to 120 hours after dosing,or until termination criteria met; Whole blood / plasma total radioactivity ratio , Pre-dose up to 120 hours after dosing,or until termination criteria met. Brief summary: 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.