Material Balance of [14C]Zorifertinib in Healthy Adult Male Participants in China
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Zdrowi mężczyźni pochodzenia chińskiego
- •Wiek od 18 do 45 lat
- •Prawidłowa masa ciała (BMI od 19 do 26, waga minimum 50 kg)
- •Pełne zrozumienie celu badania i dobrowolna zgoda na uczestnictwo
- •Zdolność do komunikacji z badaczami i stosowania się do instrukcji badania
✗ Disqualifies
- •Nieprawidłowe wyniki badań fizykalnych, pomiarów ciśnienia, analiz krwi lub moczu
- •Nieprawidłowe zapisanie czynności serca na elektrokardiogramie (EKG)
- •Dodatni wynik na wirusy zapalenia wątroby (HBV, HCV), syfilis lub HIV
- •Nieprawidłowe wyniki badania oczu
- •Stosowanie leków wpływających na metabolizm w ciągu 30 dni przed badaniem
- •Stosowanie leków na receptę, leków bez recepty lub suplementów diety w ciągu 14 dni przed badaniem
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Last updated (source)
- July 8, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (1)
The First Affiliated Hospital of Soochow University
Suzhou, China
Trial contact
John Ge, M.D.
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/9/2026.
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