Pharmacokinetic Study of Sudapyridine（WX-081）in Healthy Chinese Subjects

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.

NCT Number	NCT06701110
Lead Sponsor	Shanghai Jiatan Pharmatech Co., Ltd
Conditions	TB
Enrollment	10 participants
Start Date	2024-09-04
Primary Completion	2025-12-12 (estimated)
Study Completion	2026-06-12 (estimated)
Updated on ClinicalTrials.gov	2024-11-22