A Phase 1 interventional study of [14C]XY0206 in Metabolism of Radioactive Substances, sponsored by Shijiazhuang Yiling Pharmaceutical Co. Ltd. Completed at 1 site in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Shijiazhuang Yiling Pharmaceutical Co. Ltd · Phase 1, Interventional, and Other
The main purpose of this clinical trial is to quantitatively analyse the total radioactivity in the excreta of subjects after oral administration of [14C]XY0206, and to obtain data on human radioactive excretion rate and main excretion routes and the radioactivity of human plasma, urine, and faeces after oral administration of [14C]XY0206 by subjects Metabolite profiling, identification of major metabolites, determination of metabolic pathways and elimination pathways; Subjects who met the criteria fasted for at least 10h before administration and took [14C]XY0206 suspension (containing about 37.5mg/100µCi[14C]XY0206) orally on an empty stomach in the morning of the first day of administration (DI).Subjects will also complete urine, stool and blood collection within a specified period of time。
Shijiazhuang Yiling Pharmaceutical Co. Ltd is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Supplementary Examination:
Individuals who are positive for any one of hepatitis B virus surface antigen, hepatitis B virus e antigen, hepatitis B virus core antibody, hepatitis C virus antibody, HIV antibody, and Treponema pallidum antibody.
Medication history:
History of illness and surgery:
37.5 mg/100 µCi \[14C\]XY0206
Drug: [14C]XY0206
On the morning of the day of medication (D1), the subject took \[14C\] XY0206 suspension orally on an empty stomach (containing approximately 37.5 mg/100 µ Ci \[14C\] XY0206).
excrement
The total radioactivity of the collected biological samples (urine+feces) from each subject exceeds 90% of the administered dose, and the radioactivity collected for two consecutive days is less than 1% of the administered dose.
Time frame: 22 days
Radioactive blood sample
The total radioactive concentration of plasma samples is less than 3 times the background value
Time frame: 22 days
Plan to share: No
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Shijiazhuang Yiling Pharmaceutical Co. Ltd