Pharmacokinetic Study of Sudapyridine（WX-081）in Healthy Chinese Subjects
ConditionTB
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorShanghai Jiatan Pharmatech Co., Ltd
About this trial
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.
Eligibility criteria
Qualifiers
Healthy adult males. Age: 18-45 years (inclusive). Body weight: BMI between 19.0 and 26.0 kg/m² (inclusive), with body weight not less than 50.0 kg.
Disqualifiers
Clinically significant abnormalities identified through physical examination, vital signs, laboratory tests (e.g., blood count, biochemistry, troponin, coagulation function, urinalysis, fecal occult blood), thyroid function, 12-lead ECG, chest X-ray, rectal examination, or abdominal ultrasound (liver, gallbladder, pancreas, spleen, kidney).
Trial design
Treatments tested in this trial
- [U-14C] WX-081
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov