Material Balance of [14C]Zorifertinib in Healthy Adult Male Participants in China
Phase I Clinical Study on Material Balance of [14C]Zorifertinib in Healthy Adult Male Participants in China
Alpha Biopharma (Jiangsu) Co., Ltd.
8 participants
Jul 6, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
Single oral administration of 200 mg/5 µCi \[¹⁴C\]Zorifertinib in healthy male subjects under fasting condition
Locations(1)
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NCT07620951