A Mass Balance Study of [14C]HS-10504 (NCT07764705) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Mass Balance Study of [14C]HS-10504
6 participantsStarted 2026-07-30
Plain-language summary
This study is a single-site, non randomized, open-label study to assess the absorption, metabolism, and excretion profile of \[14C\] HS-10504 in healthy adult male subjects.
Who can participate
Age range
18 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
. Subjects must be healthy adult males.
. Aged 18 years or older.
. BMI between 19.0 and 26.0 kg/m² (inclusive) and weight no less than 50 kg (inclusive).
. Able and willing to provide written informed consent voluntarily.
Exclusion criteria
. Clinically significant abnormalities in comprehensive physical examination, vital signs, laboratory tests (blood routine, blood biochemistry, thyroid function, coagulation function, urinalysis, stool routine and occult blood), 12-lead electrocardiogram, ophthalmic examination (slit lamp, intraocular pressure, and fundus photography), chest X-ray (posteroanterior view), digital rectal examination, abdominal ultrasound (liver, gallbladder, pancreas, and spleen), urinary system ultrasound (kidney, ureter, bladder, and prostate), echocardiography, etc.;
. Use of any prescription drugs, over-the-counter drugs, herbal medicines, or health supplements (except topical agents with local effects) within 30 days prior to screening, or use of any drug with a washout period of less than 7 half-lives (whichever is longer) before screening;
. Participation in other clinical trials and use of other investigational drugs or devices within 3 months prior to screening or during the screening period, or planned participation in another clinical trial during this study;
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
1
Total radiorecovery and cumulative radiorecovery in urine and feces per time interval.
Timeframe: All excreted urine and feces samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection.
2
Percentage of major metabolites in human plasma, urine, and feces.
Timeframe: Plasma, urine and feces samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection.
3
The percentage of plasma total radioactivity exposure accounted for by the parent compound and its metabolites (%AUC).
Timeframe: Plasma samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection.
4
The percentage of the administered dose recovered as parent drug and metabolites in urine and feces
Timeframe: Urine and feces samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection.
. History of any clinically significant disease or condition that may affect the study results, as judged by the investigator, including but not limited to cardiovascular, respiratory, endocrine, neurological, digestive, urinary, or hematological, immune, psychiatric, or metabolic diseases; or onset of a new illness before study drug administration that is considered by the investigator to make the subject unsuitable for participation;
. Major surgery within 6 months prior to screening, or a surgical incision that has not completely healed;
. Any surgical or medical condition that may significantly affect drug absorption, distribution, metabolism, and excretion, or that may pose a hazard to the participant;
. Predisposition to allergic reactions, or allergic constitution (e.g., allergy to pollen, any drugs/foods), or history of severe allergy;