A Randomized, Open-label, Crossover Study to Evaluate Relative Bioavailability, and Food Effect of HDM1002 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- AUC[0-∞]
研究概览
简要总结
The main purpose of this study is to evaluate the effect of formulation on relative bioavailability of HDM1002, and the food effect on pharmacokinetics of HDM1002.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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.
- •Male subject weighed ≥50.0 kg, female subject weighed ≥45.0 kg, and a body mass index (BMI) within the range of 19.0 - 30.0 kg/m2 (including cut-off values).
- •Female subject of childbearing potentiaafter last dose, who have no childbearing plans and agrl during signature ICF to 30 days after last dose and male subject during signature ICF to 90 days ee to use highly effective contraception and consent not to donate sperm and oocyte during this period.
排除标准
- •Subject 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 attack within 3 months prior to screening.
- •Subject 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
Period 1: Subjects received HDM1002 table (200 mg×1）in fasted state; Period 2: Subjects received HDM1002 tables (100 mg×2）in fasted state; Period 3: Subjects received HDM1002 table (200 mg×1）in fed state.
干预措施: HDM1002 (Drug)
Cohort 2
Period 1: Subjects received HDM1002 tables (100 mg×2）in fasted state; Period 2: Subjects received HDM1002 table (200 mg×1）in fed state; Period 3: Subjects received HDM1002 table (200 mg×1）in fasted state.
干预措施: HDM1002 (Drug)
Cohort 3
Period 1: Subjects received HDM1002 table (200 mg×1）in fed state; Period 2: Subjects received HDM1002 table (200 mg×1）in fasted state; Period 3: Subjects received HDM1002 tables (100 mg×2）in fasted state.
干预措施: HDM1002 (Drug)
结局指标
主要结局
AUC[0-∞]
时间窗: Day1-Day17
Area under the curve from time 0 hour to ∞
AUC[0-t]
时间窗: Day1-Day17
Area under the curve from time 0 to t hour
Cmax
时间窗: Day1-Day17
Maximum observed concentration
Tmax
时间窗: Day1-Day17
Time to maximum plasma concentration
t1/2
时间窗: Day1-Day17
Half life
CL/F
时间窗: Day1-Day17
Apparent Clearance
Vz/F
时间窗: Day1-Day17
Apparent volume of distribution
F
时间窗: Day1-Day17
Relative Bioavailability
次要结局
- Adverse events (AEs)(Day1-Day17)