Phase I Clinical Study on 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.
• Healthy Chinese males;
• Age at the time of signing the informed consent form: 18-45 years (inclusive);
• Body mass index (BMI) ranging from 19-26 kg/m2 (inclusive), with a body weight of no less than 50 kg;
• Fully understand the purpose and requirements of this study and voluntarily sign the informed consent form;
• Be able to communicate well with the investigators and complete the trial according to the protocol.
• The 14C content in plasma and urine samples obtained during screening are within general environmental 14C background levels. Directly analyzed plasma samples must have values ≤150 pMC, and urine samples containing petroleum-based carbon carriers must have values ≤50 pMC.