Material Balance of [14C]Zorifertinib in Healthy Adult Male Participants in China

StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Primary endpoints: details revised at 4 of 11 entries Show 7 more changesShow less
    • Trial completed
    • Final enrollment: 6 participants (planned 8)
    • Primary completion date changed from estimate of Aug 2026 to Jul 18, 2026
    • Study completion date changed from estimate of Aug 2026 to Aug 3, 2026
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 8 of 9 entries
    • Site details revised
  2. Recruitment opened
    • Start date changed from estimate of Jun 2026 to Jul 6, 2026
    • Site details revised
    v3
  3. Study title shortened, about 5 wordsv2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07620951
Lead Sponsor Alpha Biopharma (Jiangsu) Co., Ltd.
Conditions
(from sponsor)		 EGFR Mutant Advanced Non-small Cell Lung Cancer, Central Nervous System (CNS) Metastases
Related terms Neoplasm Metastasis
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov