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

Launched by SHANGHAI JIATAN PHARMATECH CO., LTD · Nov 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called Sudapyridine (WX-081) to understand how it behaves in the body after a single dose. Specifically, the researchers want to see how the drug is absorbed, distributed, and eliminated from the body in healthy Chinese men. The trial will include 6 to 10 participants, who will provide blood, urine, and fecal samples over a certain period to help gather important information about the drug's effects.

To participate in this study, men aged 18 to 45 who are in good health may be eligible. Participants must have a specific body weight and not have any significant health issues that could affect the study results, such as heart problems or infections. During the trial, participants will take the medication and then provide samples for analysis. It’s important for potential participants to know that they need to avoid certain medications and supplements before joining the trial. Overall, this study aims to help researchers learn more about Sudapyridine and its potential use in treating tuberculosis (TB).

Gender

MALE

Eligibility 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.