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

Recruiting Phase 1 Interventional Study
EGFR Mutant Advanced Non-small Cell Lung Cancer Central Nervous System (CNS) Metastases
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 45
Sex
Male
Trial phase
Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
8 (estimated)
Sponsor
Alpha Biopharma (Jiangsu) Co., Ltd. · Industry
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About This 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, u…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Healthy Chinese males; 2. Age at the time of signing the informed consent form: 18-45 years (inclusive); 3. Body mass index (BMI) ranging from 19-26 kg/m2 (inclusive), with a body weight of no less than 50 kg; 4. Fully understand the purpose and requirements of this study and…
Contacts

John Ge, M.D.

+86 (0)21-63862197

john.ge@alphabiopharma.com.cn

CONTACT