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.
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…
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