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

NCT06701110 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-11-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

[U-14C] WX-081

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.

Sponsors & Collaborators

  • Shanghai Jiatan Pharmatech Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-04
Primary Completion
2025-12-12
Completion
2026-06-12

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06701110 on ClinicalTrials.gov