Evaluating the pharmacokinetics of Sudapyridine in healthy Chinese males

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.