A Phase I, Open-Label, Parallel, Fixed-Sequence Study to Evaluate the Effect of Repeated Administration of Rifampicin or Itraconazole on the Pharmacokinetics of HDM1002 in Healthy Adult Chinese Subjects

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2024年8月16日最近更新: 2024年8月20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: 40
试验地点: 1
主要终点: AUC[0-24 h] of HDM1002

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

The purpose of this study is to characterize the effect of rifampicin and itraconazole on the PK of single dose of HDM1002 in healthy adult subjects. The safety and tolerability of HDM1002 and rifampicin or itraconazole when given separately or together will also be evaluated.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•According to the medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination results during the screening period, the investigator considers the subject to be in good general health.
•Age range of 18-45 years old (including range), no limit to gender.
•Eligible male participant weighed ≥50.0 kg, eligible female participant weighed ≥45.0 kg, and had a body mass index (BMI) within the range of 19.0 - 32.0 kg/m2 (including cut-off values).

排除标准

•Participant has a history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin≥50 ng/L during the screening period.
•History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
•History of acute cholecystitis within 3 month prior to initiation of screening period.
•Participant judged by investigator has dysphagia, diseases or conditions that affect gastric emptying, or affect the absorption of gastrointestinal nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.
•History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period.
•During screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant .
•Taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug.
•History of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission.
•Presence of clinically significant ECG results judged by the investigator at screening.

研究组 & 干预措施

Cohort 1: HDM1002 and rifampicin

Experimental

Part 1: Single dose of HDM1002

Part 2: Once daily dose of rifampicin with single dose of HDM1002

干预措施: HDM1002 and rifampicin (Drug)

Cohort 2: HDM1002 and itraconazole

Experimental

Part 1: Single dose of HDM1002

Part 2: Once daily dose of itraconazole with single dose of HDM1002

干预措施: HDM1002 and itraconazole (Drug)