Healthy Subjects Clinical Trial
Official title:
A Mass Balance Study of [14C]ABSK021 in Healthy Adult Male Chinese Subjects
This study is a single-site, open-label, single-cohort, single-dose study to assess the absorption, metabolism, and excretion profile of [14C] ABSK021 in healthy adult male subjects. The study plans to enroll 6 to 10 healthy male subjects to ensure at least 6 evaluable subjects.
Subjects will be screened within 14 days before dose administration (D-14 to D-3), and will be admitted to the trial ward two days before dose administration (D-2). On Day 1, subjects will receive a single oral dose of approximately 50 mg ABSK021 containing approximately 100 μCi of [14C] ABSK021 in the fasted state. All excreted urine and feces samples and blood samples at specified time points during 0-504 hours after dosing will be collected. Random feces within 48 hours prior to dosing and random urine within 24 hours prior to dosing will be collected as blank samples (if there are multiple blank samples, the most recent blank sample before dosing will be selected for analysis). ;
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