A Phase1 Study to Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.1 个研究点分布在 1 个国家目标入组 10 人开始时间: 2024年8月最近更新: 2024年8月28日

适应症

干预措施

试验速览

阶段: 1 期
状态: 尚未招募
发起方: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
入组人数: 10
试验地点: 1
主要终点: Plasma and whole blood Tmax of radioactivity

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

In this study, a single dose of [14C] radiolabelled HDM1002 will be administered orally. The main purpose of this study is to find out how much of HDM1002 and its metabolites pass from blood into urine and feces, and characterize the metabolic profile and routes of excretion of oral [14C] HDM002.

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 45 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Male, healthy adult;
•Age of 18 to 45 years old (both inclusive);
•Body mass index (BMI) between 19.0- 32.0 kg/m2 (both inclusive) and body weight no less than 50.0 kg.

排除标准

•Clinically significant diseases at the time of screening;
•History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin ≥ 35 ng/L during the screening period;
•History of chronic pancreatitis or acute pancreatitis within 3 months prior to screening;
•History of acute cholecystitis attack within 3 months prior to screening;
•Participant judged by investigator has dysphagia, diseases or conditions that affect gastric emptying or affect the absorption of nutrients in the gastrointestinal tract, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.;
•Any of the following: habitual constipation or diarrhea, hemorrhoids or accompanied by perianal disease, irritable bowel syndrome, inflammatory bowel disease, etc;
•Use of any prescription medication, over-the-counter medication, Chinese herbal medicine or food supplement within 14 days or 5 half-lives (whichever is longer) prior to the screening period;
•Patients with any abnormal and clinically significant examinations in given comprehensive physical examination;
•History of drug abuse (e.g., morphine, ketamine, tetrahydrocannabinolic acid, metham phetamine, methylenedioxyamphetamine, cocaine) or positive urine drug test during the screening period;
•Positive for hepatitis B surface antigen or E antigen, hepatitis C virus antibody IgG (Anti-HCV IgG), human immunodeficiency virus antigen/antibody combination test (HIV-Ag/Ab) and Treponema pallidum antibody during the screening period.
•Engaged in working conditions requiring long-term exposure to radioactivity; or significant radioactive exposure ( ≥ 2 CT chest/abdomen tests, or ≥ 3 all other types of X-rays test) within 1 year prior to the trail, or participated in radio-label trails;

研究组 & 干预措施

[14C] HDM1002

Experimental

A single dose of HDM1002 and [14C] HDM1002 administered orally.

干预措施: [14C] HDM1002 (Drug)