Pharmacokinetics and Mass Balance Study of WX-081 (Sudapyridine) in Healthy Chinese Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Cumulative Excretion Rate of Total Radioactivity in Urine
研究概览
简要总结
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.
详细描述
The study involves healthy male volunteers who will receive a single oral dose of [U-14C] WX-081 containing approximately 450 mg (100 μCi) after fasting overnight. Samples of blood, plasma, urine, and feces will be collected during an intensive phase (up to 504 hours post-dose) and a sparse phase (up to 51 days). Pharmacokinetic and excretion parameters will be calculated, and metabolic pathways will be determined via radiolabeled metabolite profiling. Volunteers will follow pre-specified dietary and procedural requirements, including pre-dose baseline assessments and post-dose fasting. Adjustments to sample collection duration or early termination will be made based on phase-specific results. Safety monitoring will continue until sample collection is complete.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Single Oral Dose of [U-14C] WX-081
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.
干预措施: [U-14C] WX-081 (Drug)
结局指标
主要结局
Cumulative Excretion Rate of Total Radioactivity in Urine
时间窗: Up to Day 51 post-dose.
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.
Cumulative Excretion Rate of Total Radioactivity in Feces
时间窗: Up to Day 51 post-dose.
The cumulative percentage of total radioactivity excreted in feces after a single oral dose of \[U-14C\] WX-081 in healthy male volunteers.
次要结局
- Identification and Percentage of Major Metabolites in Plasma, Urine, and Feces(Up to Day 51 post-dose)