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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
[U-14C] WX-081
DrugA 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Single Oral Dose of [U-14C] WX-081Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cumulative 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.2
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.Secondary outcomes
1
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-doseSponsors and contacts
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Source ClinicalTrials.gov