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

NCT06701110 | Recruiting Phase 1 DMC

• 1 other identifier: JYP0081M102
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

TB

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to Day 51 post-dose.

Secondary Outcomes (1)

• Identification and Percentage of Major Metabolites in Plasma, Urine, and Feces

  Up to Day 51 post-dose

Study Arms (1)

Single Oral Dose of [U-14C] WX-081

EXPERIMENTAL

Participants will receive a single oral dose of approximately 450 mg (100 μCi) of \[U-14C\] WX-081. The study involves collecting biological samples, including blood, plasma, urine, and feces, at specified time points to evaluate pharmacokinetics, metabolism, mass balance, and excretion pathways.

Drug: [U-14C] WX-081

Interventions

[U-14C] WX-081 DRUG

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.

Also known as: Sudapyridine

Single Oral Dose of [U-14C] WX-081

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Voluntarily signed the informed consent form. Able to communicate effectively with investigators and comply with the study protocol.

You may not qualify if:

• 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).
• Prolonged corrected QT interval (QTcF) \> 450 msec on 12-lead ECG. Positive results for hepatitis B surface antigen (HBsAg or HBeAg), hepatitis C antibody (HCV-Ab), syphilis antibody, or HIV antigen/antibody (HIV-Ag/Ab).
• Use of drugs that inhibit or induce hepatic enzymes or transporters within 30 days prior to screening.
• Use of prescription or over-the-counter medications, herbal remedies, or dietary supplements (e.g., vitamins, calcium) within 14 days prior to screening.
• Any clinically significant disease or condition that may affect study results, including but not limited to cardiovascular, respiratory, endocrine, neurological, gastrointestinal, urinary, hematological, immune, psychiatric, or metabolic disorders.
• Conditions that could affect drug absorption, such as a history of gastric surgery (e.g., gastrectomy, gastric bypass), gallbladder removal, or inflammatory bowel disease.
• History of organic heart disease, heart failure, myocardial infarction, angina, unexplained arrhythmia, ventricular tachycardia, atrioventricular block, long QT syndrome, or family history of sudden cardiac death due to cardiac reasons.
• Major surgery within 6 months prior to screening or incomplete surgical wound healing.
• Known hypersensitivity or allergy to two or more substances, or potential allergy to the investigational drug or its excipients (e.g., lactose, low-substituted hydroxypropyl cellulose, sodium lauryl sulfate, silicon dioxide, magnesium stearate).
• Hemorrhoids or perianal conditions with regular or current rectal bleeding.

Sponsors & Collaborators

• Shanghai Jiatan Pharmatech Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Interventions

sudapyridine

Central Study Contacts

Miao Li Yan, M.D.

CONTACT

+86-0512-67972858; miaolysuzhou@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study involves a single cohort of healthy male volunteers receiving a single oral dose of \[U-14C\] WX-081 to evaluate pharmacokinetics, metabolism, and mass balance.

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 22, 2024
• Study Start: September 4, 2024
• Primary Completion: December 12, 2025
• Study Completion (Estimated): June 12, 2026
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

CN (1)