CompletedPhase 1

Study on [14C]HMPL-453（FGFR Inhibitor） in Healthy Chinese Adult Male Subjects

China6 participantsStarted 2025-02-26

Plain-language summary

To evaluate the absorption, metabolism and excretion in healthy Chinese male subjects after a single oral dose of \[14C\]HMPL-453

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

. The subjects fully understand the content of the experiment, the process and possible adverse reactions, voluntarily sign the informed consent form, can communicate well with the researchers, and can complete all experimental procedures as specified in the protocol;
. Healthy male subjects aged 18-45 years (inclusive, based on the time of signing the informed consent form);
. Body weight ≥50 kg, body mass index (BMI) 19\~26 kg/m2 (including limit values);
. Subjects must commit to having no plans for pregnancy or sperm donation from the time of signing the informed consent form until 180 days after the end of the study medication administration. If the sexual partner is a female of childbearing potential, then a highly effective method of contraception should also be used.

Exclusion criteria

. History of severe allergies (such as drug allergies) and acute allergic rhinitis or food allergies within 2 weeks prior to screening, allergic to any investigational drug (or its excipients) given in this study;
. History of hypertension, or baseline blood pressure: systolic ≥140 mmHg and/or diastolic ≥90 mmHg;
. Existing or occurring during the screening period clinically abnormal manifestations that need to be excluded (as judged by the researcher), including but not limited to diseases of the nervous/mental system, respiratory system, cardiovascular system, digestive system (any history of gastrointestinal diseases affecting oral or absorption of drugs), blood and lymphatic system, urinary system, endocrine system, immune system;

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

Human Mass balance

Timeframe: Day-1 ~Day15

Human Mass balance

Timeframe: Day-1 ~Day15

Human Mass balance

Timeframe: Day-1 ~Day15

Trial details

NCT IDNCT07644442

SponsorHutchmed

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-14

View on ClinicalTrials.gov More Mass Balance Study trials

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

. The subjects fully understand the content of the experiment, the process and possible adverse reactions, voluntarily sign the informed consent form, can communicate well with the researchers, and can complete all experimental procedures as specified in the protocol;
. Healthy male subjects aged 18-45 years (inclusive, based on the time of signing the informed consent form);
. Body weight ≥50 kg, body mass index (BMI) 19\~26 kg/m2 (including limit values);
. Subjects must commit to having no plans for pregnancy or sperm donation from the time of signing the informed consent form until 180 days after the end of the study medication administration. If the sexual partner is a female of childbearing potential, then a highly effective method of contraception should also be used.

Exclusion criteria

. History of severe allergies (such as drug allergies) and acute allergic rhinitis or food allergies within 2 weeks prior to screening, allergic to any investigational drug (or its excipients) given in this study;
. History of hypertension, or baseline blood pressure: systolic ≥140 mmHg and/or diastolic ≥90 mmHg;
. Existing or occurring during the screening period clinically abnormal manifestations that need to be excluded (as judged by the researcher), including but not limited to diseases of the nervous/mental system, respiratory system, cardiovascular system, digestive system (any history of gastrointestinal diseases affecting oral or absorption of drugs), blood and lymphatic system, urinary system, endocrine system, immune system;