NCT04126707已完成1 期
A Single-center, Open-label, Single-dose Phase I Study to Investigate the Absorption, Metabolism and Excretion of [14C] HQP1351 After a Single Oral 30mg (100µCi) Dose in Healthy Chinese Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Radioactivity concentration of each blood and plasma sample
研究概览
简要总结
The objective of this study is to determine the mass balance and routes of excretion of total radioactivity after a single oral 30mg (100µCi) dose of [14C] HQP1351 given as a suspension. For further clinical development, human mass balance data are required to elucidate the absorption, metabolism, and excretion of HQP1351.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •A subject will be eligible for study participation if he meets the following criteria:
- •Healthy male volunteers between the ages of 18 to 50 years old, inclusive;
- •Body weight >=50 kg, Body mass index (body weight(kg)/hight2(m2)) between 19 and 26 kg/m2 (inclusive);
- •Normal physical findings, clinical laboratory values, vital signs and 12-lead ECG, or any abnormality that is non-clinically significant;
- •Male subjects of reproductive potential with partners will be instructed to, and must be willing to practice a highly effective method of birth control for the duration of the study and continuing 1 year after discontinuing treatment with the investigational product.
- •Must understand, and voluntarily sign the informed consent, comply with the requirements of the study.
排除标准
- •A subject will not be eligible for study participation if he meets any of the exclusion criteria:
- •History of or current clinically significant cardio, pulmonary, endocrine, metabolism, renal, hepatic, gastrointestinal, dermatology, infection, hematology, neurological, mental disease or disorder;
- •Positive test for HBsAg, HBeAg, anti-HCV, anti-HIV or syphilis antibody;
- •Abnormality in blood pressure, including hypertensive BP (SBP>=140 mmHg, or DBP >=90 mmHg), or hypotensive BP (SBP<90 mmHg, or DBP <=55 mmHg), Pulse rate<55 bpm or >100 bpm;
- •Long-QT syndrome or family history of it, or QTcB interval > 450 ms; intraventricular blocks or left/right bundle branch block or QRS>120ms; frequent ventricular ectopic beats (any 10s ECG ventricular premature beat >= 1 in screening period); or abnormal resting heart rate (> 100 bpm)
- •The following abnormal clinical laboratory values
- •HGB < LLN or HGB>ULN, and is judged as clinically significant by the investigator；
- •Abnormal ALB, TP, CRE, ALT, AST, BIL, BUN, GLU value, and is judged as clinically significant by the investigator;
- •Received any drug within 14 days before taking the investigational drug, including any prescription drug, OTC drug, herbal drug or health care product with medicinal effect;
- •Received any other investigating products or participated in any clinical trails three month before screening or within 10 t1/2 after receiving other investigating products;
- •History of or current swallowing disorder, active gastrointestinal diseases, or other diseases that significantly affect absorption, distribution, metabolism and excretion of drugs;
- •Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease or history of gastrointestinal surgery and cholecystectomy;
- •Hemorrhoids or perianal disease with regular/perianal bleeding;
- •Allergies, have allergies to two or more drugs or foods; or have known allergies to the components of the drug (microcrystalline cellulose, stearic acid, croscarmellose sodium);
- •Have donated 400ml or more of blood or plasma 3 months prior to the study drug administration, or more than 50ml within 2 weeks prior to administration;
- •Vaccination was administered within 6 months prior to screening or during screening;
- •History of drug or alcohol abuse;
- •Smoking (> 10 cigarette / day), drinking (> 15 g, pure alcohol / day, equivalent to 450 ml beer, 150 ml wine or 50 ml low-alcohol liquor), or abusing drugs within last 3 months;
- •Subject with mentally ill and could not understand the property, scope and possible consequences of the study;
- •subject in prison or whose freedom is restricted by administrative or legal issues;
- •Failure to comply with clinical study protocols, such as non-cooperation, follow-up visit and completion of entire study;
- •Abnormal coagulation function or known severe bleeding tendency;
- •Subjects who have participated in radiolabeled clinical study prior to drug administration;
- •Significant radiation exposure within one year prior to drug administration (more than one exposure from chest X-ray, CT scan, or barium meal examination and radiation-related occupations).
- •Investigators think that subjects are not suitable to participate in the study.
研究组 & 干预措施
[14C] HQP1351
Experimental
To investigate the absorption properties, as well as to evaluate the mass balance and elucidate the pathways of biotransformation after a single oral dose (30mg, 100µCi) of [14C] HQP1351 to healthy Chinese male subjects.
干预措施: [14C] HQP1351 (Drug)
结局指标
主要结局
Radioactivity concentration of each blood and plasma sample
时间窗: Day 1- Day 15
Use liquid scintillation counter to evaluate Radioactivity concentration of each blood and plasma sample
Radioactivity concentration of each urine samples
时间窗: Day 1- Day 15
Use liquid scintillation counter to evaluate Radioactivity concentration of each urine sample
Radioactivity concentration of each feces samples
时间窗: Day 1- Day 15
Use liquid scintillation counter to evaluate Radioactivity concentration of each feces sample
Total recovery of radioactivity in urine and feces
时间窗: Day 1- Day 15
Calculate the total radioactivity in urine and feces based on the radioactivity concentration of each sample
次要结局
- Plasma drug concentrations(Day 1- Day 15)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Day 1- Day 15)
研究者
研究点 (1)
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