This single-center, open-label, non-randomized study aims to evaluate the pharmacokinetics, mass balance, and metabolic pathways of WX-081 (Sudapyridine) following a single oral dose of \[U-14C\] WX-081 in healthy Chinese male volunteers. A total of 6-10 subjects will be enrolled to obtain complete samples and data from at least six participants. Biological samples, including blood, plasma, urine, and feces, will be collected over a specified time period. The study will assess pharmacokinetic parameters, excretion pathways, and identify major metabolites contributing to over 10% of plasma exposure.
The study involves healthy male volunteers who will receive a single oral dose of \[U-14C\] WX-081 containing approximately 450 mg (100 μCi) after fasting overnight. Samples of blood, plasma, urine, and feces will be collected during an intensive phase (up to 504 hours post-dose) and a sparse phase (up to 51 days). Pharmacokinetic and excretion parameters will be calculated, and metabolic pathways will be determined via radiolabeled metabolite profiling. Volunteers will follow pre-specified dietary and procedural requirements, including pre-dose baseline assessments and post-dose fasting. Adjustments to sample collection duration or early termination will be made based on phase-specific results. Safety monitoring will continue until sample collection is complete.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
10
A single oral dose of approximately 450 mg (100 μCi) of \[U-14C\] WX-081 will be administered to healthy male volunteers. The study will involve pharmacokinetic assessments, including metabolism, mass balance, and excretion pathways, through the collection of biological samples such as blood, plasma, urine, and feces.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGCumulative Excretion Rate of Total Radioactivity in Urine
The cumulative percentage of total radioactivity excreted in urine and feces after a single oral dose of \[U-14C\] WX-081 in healthy male volunteers.
Time frame: Up to Day 51 post-dose.
Cumulative Excretion Rate of Total Radioactivity in Feces
The cumulative percentage of total radioactivity excreted in feces after a single oral dose of \[U-14C\] WX-081 in healthy male volunteers.
Time frame: Up to Day 51 post-dose.
Identification and Percentage of Major Metabolites in Plasma, Urine, and Feces
The percentage of total radioactivity in plasma attributable to the parent drug and its metabolites (≥10% of total AUC) and the percentage of dose excreted in urine and feces as the parent drug and metabolites.
Time frame: Up to Day 51 post-dose
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