Not Yet RecruitingPhase 1

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

China8 participantsStarted 2026-06

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy Chinese males;
. Age at the time of signing the informed consent form: 18-45 years (inclusive);
. Body mass index (BMI) ranging from 19-26 kg/m2 (inclusive), with a body weight of no less than 50 kg;
. Fully understand the purpose and requirements of this study and voluntarily sign the informed consent form;
. Be able to communicate well with the investigators and complete the trial according to the protocol.
. The 14C content in plasma and urine samples obtained during screening are within general environmental 14C background levels. Directly analyzed plasma samples must have values ≤150 pMC, and urine samples containing petroleum-based carbon carriers must have values ≤50 pMC.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total radioactive recovery and cumulative total radioactive recovery in urine and feces at each time interval

Timeframe: Pre-dose up to 312 hours after dosing, or until termination criteria met

Percentage of total radioactivity exposure (%AUC), percentage of parent drug and its metabolites (%Dose), and metabolite identification

Timeframe: Pre-dose up to 312 hours after dosing, or until termination criteria met

Peak Plasma Concentration (Cmax)

Timeframe: Pre-dose up to 120 hours after dosing,or until termination criteria met

Time to Peak Concentration (Tmax)

Timeframe: Pre-dose up to 120 hours after dosing,or until termination criteria met

Area under the plasma concentration versus time curve (AUC)

Timeframe: Pre-dose up to 120 hours after dosing,or until termination criteria met

Elimination Half-Life (t1/2)

Timeframe: Pre-dose up to 120 hours after dosing,or until termination criteria met

Trial details

NCT IDNCT07620951

SponsorAlpha Biopharma (Jiangsu) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08

Contact for this trial

John Ge, M.D.

+86 (0)21-63862197 john.ge@alphabiopharma.com.cn

View on ClinicalTrials.gov More EGFR Mutant Advanced Non-small Cell Lung Cancer trials

Plain-language summary

Who can participate

Age range

18 Years – 45 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy Chinese males;
. Age at the time of signing the informed consent form: 18-45 years (inclusive);
. Body mass index (BMI) ranging from 19-26 kg/m2 (inclusive), with a body weight of no less than 50 kg;
. Fully understand the purpose and requirements of this study and voluntarily sign the informed consent form;
. Be able to communicate well with the investigators and complete the trial according to the protocol.
. The 14C content in plasma and urine samples obtained during screening are within general environmental 14C background levels. Directly analyzed plasma samples must have values ≤150 pMC, and urine samples containing petroleum-based carbon carriers must have values ≤50 pMC.

Exclusion criteria

What they're measuring

Total radioactive recovery and cumulative total radioactive recovery in urine and feces at each time interval

Timeframe: Pre-dose up to 312 hours after dosing, or until termination criteria met

Percentage of total radioactivity exposure (%AUC), percentage of parent drug and its metabolites (%Dose), and metabolite identification

Timeframe: Pre-dose up to 312 hours after dosing, or until termination criteria met

Peak Plasma Concentration (Cmax)

Timeframe: Pre-dose up to 120 hours after dosing,or until termination criteria met

Time to Peak Concentration (Tmax)

Timeframe: Pre-dose up to 120 hours after dosing,or until termination criteria met

Area under the plasma concentration versus time curve (AUC)

Timeframe: Pre-dose up to 120 hours after dosing,or until termination criteria met

Elimination Half-Life (t1/2)

Timeframe: Pre-dose up to 120 hours after dosing,or until termination criteria met