OncRef

Clinical Trial: NCT07620951

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

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:Alpha Biopharma (Jiangsu) Co., Ltd.
Information Provided By:Alpha Biopharma (Jiangsu) Co., Ltd.
Last Update Posted:2026-09-22

Study Overview

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.

Official Title

Phase I Clinical Study on Material Balance of [14C]Zorifertinib in Healthy Adult Male Participants in China

Conditions

EGFR Mutant Advanced Non-small Cell Lung Cancer, Central Nervous System (CNS) Metastases

Intervention / Treatment

  • Drug: [14C]Zorifertinib Oral Formulation

Other Study ID Numbers

  • AZD3759-CIT-101

Start Date (Actual)

2026-07-06

Primary Completion Date (Actual)

2026-07-18

Study Completion Date (Actual)

2026-08-03

Enrollment (Actual)

6

Study Type

Interventional

Phase

Phase 1