A Study to Evaluate the Mass Balance of [14C] HRS-5965 in Healthy Adult Male Volunteers (NCT06567392) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Mass Balance of [14C] HRS-5965 in Healthy Adult Male Volunteers
China6 participantsStarted 2024-09-03
Plain-language summary
Evaluate the Mass Balance of \[14C\] HRS-5965 in Healthy Adult Volunteers.
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
. Sign the informed consent form prior to the trial and have a full understanding of the trial's procedures, content, and potential adverse reactions;
. Healthy adult males between 18 and 45 years;
. Body weight ≥50 kg, and the body mass index (BMI) of 19 to 26 kg/m2;
. From the signing of the informed consent form until 12 months after the last administration, the subject (including partner) has no family planning and is willing to use the high-efficiency contraceptive measures specified in the plan.
Exclusion criteria
. Comprehensive physical examination, vital signs, laboratory tests (blood routine, blood biochemistry, coagulation function, urine analysis, fecal analysis, thyroid function), full chest anteroposterior and lateral film, abdominal ultrasound, and anoscope results that the researcher deems clinically significant.
. Patients with QTcF\>450 msec at the time of screening or baseline, or 12 lead electrocardiogram examination are abnormal and determined by the researcher to have clinical significance.
. Patients with clinically significant abnormalities in ophthalmic examinations (color vision, slit lamp, intraocular pressure, and fundus photography).
. Patients whose blood creatinine levels exceed the upper limit of normal values.
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 radioactive recovery rate in urine and feces at each time interval
Timeframe: 0-240 hours
2
Cumulative total radioactive recovery rate in urine and feces
Timeframe: 0-240 hours
3
3. Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC)
Timeframe: 0-192 hours
4
Percentage of parent drug and its metabolites in urine and feces as a percentage of administered dose (%Dose)
. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding the upper limit of normal values (ULN), or total bilirubin exceeding 1.5 times ULN.
. Hepatitis B surface antigen (HBsAg) positive, or anti hepatitis C virus (HCV) antibody positive, or human immunodeficiency virus (HIV) antibody positive, or Treponema pallidum antibody positive.
. Abuse of drugs or use of soft drugs (such as marijuana) in the three months prior to screening, or use of hard drugs (such as amphetamines, phencyclidine, etc.) in the year prior to screening; Or screening period urine drug test positive individuals.
. Patients used any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, traditional Chinese patent medicines and simple preparations and dietary supplements) within 4 weeks before screening; Or select those who are within 5 half-lives of the drug at the time of screening (whichever is longer).