Evaluating the pharmacokinetics of Sudapyridine in healthy Chinese males
Pharmacokinetics and Mass Balance Study of WX-081 (Sudapyridine) in Healthy Chinese Volunteers
This study is testing how the body processes a new drug called Sudapyridine in healthy Chinese men after they take a single dose.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Male |
| Sponsor | Shanghai Jiatan Pharmatech Co., Ltd Industry-sponsored |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT06701110 on ClinicalTrials.gov |
What this trial studies
This is a single-center, open-label, non-randomized study designed to assess the pharmacokinetics, mass balance, and metabolic pathways of WX-081 (Sudapyridine) after a single oral dose in healthy Chinese male volunteers. The study will enroll 6-10 participants who will receive a dose of approximately 450 mg of radiolabeled WX-081 after fasting overnight. Biological samples, including blood, plasma, urine, and feces, will be collected over a period of up to 51 days to evaluate pharmacokinetic parameters and identify major metabolites. Safety monitoring will be conducted throughout the study duration.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adult males aged 18-45 with a BMI between 19.0 and 26.0 kg/m².
Not a fit: Patients with clinically significant health abnormalities or those with prolonged QT intervals or positive infectious disease markers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the metabolism and safety of Sudapyridine, potentially leading to improved treatments for tuberculosis.
How similar studies have performed: While this specific pharmacokinetic approach may be novel, similar studies evaluating drug metabolism in healthy volunteers have shown success in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Suzhou, Jiangsu
- The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Miao Li Yan, M.D.
- Email: miaolysuzhou@163.com
- Phone: +86-0512-67972858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.