A Phase I, Single-center, Open-Label, Single-Arm, Fixed-Sequence Study to Evaluate the Drug-Drug Interaction of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin in Overweight/Obese Adult Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- AUC[0-∞]
研究概览
简要总结
The purpose of this study is to characterize the drug-drug intereaction of HDM1002 and metformin, empagliflozin, midazolam, valsartan, and warfarin in overweight/obese adult subjects. The safety and tolerability of HDM1002 with metformin, empagliflozin, midazolam, valsartan, and warfarin when given separately or together will also be evaluated
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
- 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.
- •Subject weighed ≥50.0 kg, and a body mass index (BMI) within the range of 24.0 - 35.0 kg/m2 (including cut-off values).
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.
- •Severe hypoglycemic events or recurrent hypoglycemic events occurred 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.
- •Any pre-existing conditions that increase the risk of bleeding, such as acute gastritis or active ulcers with bleeding, hemorrhagic cerebral infarction, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, and active pathological bleeding, 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
experimental arm
Cohort 1 (Study on the Interaction between HDM1002 and Metformin, empagliflozin), Cohort 2 (Study on the Interaction between HDM1002 and Midazolam, valsartan, Warfarin)
干预措施: Warfarin (Drug)
experimental arm
Cohort 1 (Study on the Interaction between HDM1002 and Metformin, empagliflozin), Cohort 2 (Study on the Interaction between HDM1002 and Midazolam, valsartan, Warfarin)
干预措施: HDM1002 (Drug)
experimental arm
Cohort 1 (Study on the Interaction between HDM1002 and Metformin, empagliflozin), Cohort 2 (Study on the Interaction between HDM1002 and Midazolam, valsartan, Warfarin)
干预措施: Metformin (Drug)
experimental arm
Cohort 1 (Study on the Interaction between HDM1002 and Metformin, empagliflozin), Cohort 2 (Study on the Interaction between HDM1002 and Midazolam, valsartan, Warfarin)
干预措施: Empagliflozin (Drug)
experimental arm
Cohort 1 (Study on the Interaction between HDM1002 and Metformin, empagliflozin), Cohort 2 (Study on the Interaction between HDM1002 and Midazolam, valsartan, Warfarin)
干预措施: Midazolam (Drug)
experimental arm
Cohort 1 (Study on the Interaction between HDM1002 and Metformin, empagliflozin), Cohort 2 (Study on the Interaction between HDM1002 and Midazolam, valsartan, Warfarin)
干预措施: Valsartan (Drug)
结局指标
主要结局
AUC[0-∞]
时间窗: through study completion, an average of 11 weeks
PK parameter of metformin, empagliflozin, midazolam, valsartan, and warfarin:Area under the curve from time 0 hour to ∞
Cmax
时间窗: through study completion, an average of 11 weeks
PK parameter of metformin, empagliflozin, midazolam, valsartan, and warfarin: Maximum observed concentration
AUC[0-t]
时间窗: through study completion, an average of 11 weeks
PK parameter of metformin, empagliflozin, midazolam, valsartan, and warfarin: Area under the curve from time 0 to t hour
次要结局
- PK parameter of HDM1002(through study completion, an average of 11 weeks)
- other PK parameters(through study completion, an average of 11 weeks)
- Adverse events (AEs)(through study completion, an average of 11 weeks)