Actively Recruiting

Phase 1
Age: 18Years - 45Years
MALE
Healthy Volunteers
NCT06701110

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

Led by Shanghai Jiatan Pharmatech Co., Ltd · Updated on 2024-11-22

10

Participants Needed

1

Research Sites

92 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 45Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy adult males aged 18 to 45 years inclusive
  • Body mass index between 19.0 and 26.0 kg/m8 inclusive
  • Body weight not less than 50.0 kg
  • Voluntarily signed informed consent
  • Able to communicate effectively and comply with the study protocol
Not Eligible

You will not qualify if you...

  • Any clinically significant abnormalities found in physical exams, vital signs, laboratory tests, ECG, chest X-ray, rectal exam, or abdominal ultrasound
  • Prolonged corrected QT interval (QTcF > 450 msec) on ECG
  • Positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, or HIV antigen/antibody
  • Use of drugs affecting liver enzymes or transporters within 30 days prior to screening
  • Use of prescription or over-the-counter medications, herbal remedies, or dietary supplements within 14 days prior to screening
  • Any significant disease or condition affecting study results including cardiovascular, respiratory, endocrine, neurological, gastrointestinal, urinary, hematological, immune, psychiatric, or metabolic disorders
  • Conditions affecting drug absorption such as previous gastric surgery, 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
  • Major surgery within 6 months prior to screening or incomplete surgical wound healing
  • Known hypersensitivity or allergy to two or more substances or to the investigational drug or its excipients
  • Hemorrhoids or perianal conditions with regular or current rectal bleeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215000

Actively Recruiting

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Research Team

M

Miao Li Yan, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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