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 range18 Years – 45 Years
SexMALE
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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；
✕. 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;
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
Timeframe: 22 days
9
Percentage of the drug and its metabolites in plasma, urine and feces to the administered dose
✕. 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);