Mass Balance Study of [14C]X842 in Healthy Adult Male Subjects (NCT07107672) | Clinical Trial Compass
CompletedPhase 1
Mass Balance Study of [14C]X842 in Healthy Adult Male Subjects
China6 participantsStarted 2022-06-15
Plain-language summary
This study is a single-site, single-dose, non-randomized, open-label study to assess the absorption, metabolism, and excretion profile of \[14C\]X842 in healthy adult male subjects. The study plans to enroll 6 to 8 healthy male subjects in China to ensure at least 4 evaluable subjects.
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 adult males;
. Age: 18 to 45 years (inclusive)
. Body weight: ≥50 kg with body mass index (BMI) between 19.0 and 26.0 kg/m² (inclusive);
. Fully understand the trial objectives, requirements, procedures, and potential adverse reactions; voluntarily participate; able to complete the study per protocol and comply with regulations; informed consent obtained in compliance with GCP;
. The subjects were able to communicate well with the researchers and complete the trial in accordance with the provisions of the protocol.
Exclusion criteria
. Subjects with abnormal and clinically significant findings in Physical examination, Vital signs, Laboratory tests (including hematology, blood biochemistry, coagulation, urinalysis, fecal occult blood),Thyroid function, 12-lead ECG, Anteroposterior chest X-ray, Abdominal ultrasound, and/or other clinically relevant investigations;
. Subjects testing positive for: Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV-Ab), Human immunodeficiency virus antibody (HIV-Ab),Treponema pallidum antibody (syphilis screening);
Medication History:
. Subjects with use of any medications known to inhibit or induce hepatic drug-metabolizing enzymes within 30 days prior to screening；
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
Mass balance: the cumulative excretion rate
Timeframe: 22 days
2
Tmax (time to maximum observed concentration)
Timeframe: 22 days
3
Cmax(maximum concentration)
Timeframe: 22 days
4
AUC(area under curve)
Timeframe: 22 days
5
t1/2 (terminal elimination half-life)
Timeframe: 22 days
6
MRT (mean residence time)
Timeframe: 22 days
7
Vd/F(apparent volume of distribution)
Timeframe: 22 days
8
whole blood/plasma ratio for the total radioactivity concentration at different time points
. Subjects with use of any prescription medications, over-the-counter drugs, Chinese herbal medicines, or dietary supplements (e.g., vitamins, calcium) within 14 days prior to screening;
Disease and Surgical History
. History of any clinically significant disease or condition that the investigator deems may affect the trial results, including but not limited to diseases of the circulatory, respiratory, endocrine, nervous, digestive, urinary systems, or blood, immune, psychiatric, and metabolic disorders;
. History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsade de pointes, ventricular tachycardia, atrioventricular block, long QT syndrome, or family history thereof (as evidenced by genetic confirmation or sudden cardiac death of close relatives at a young age);
9
Percentage of the drug and its metabolites in plasma, urine and feces to the administered dose