Healthy Subjects, Overweight Subject
Conditions
Keywords
HDM1002
Brief summary
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
Interventions
DRUGMetformin
Administered orally
DRUGEmpagliflozin
Single dose; Administered orally
DRUGMidazolam
Single dose; Administered orally
DRUGValsartan
Single dose; Administered orally
DRUGWarfarin
Single dose; Administered orally
DRUGHDM1002
Administered orally
Sponsors
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. 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. 2. Age range of 18-45 years old (including range), no limit to gender. 3. 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).
Exclusion criteria
1. 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. 2. History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening. 3. History of acute cholecystitis attack within 3 months prior to screening. 4. Severe hypoglycemic events or recurrent hypoglycemic events occurred within 3 months prior to screening 5. 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. 6. 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 7. History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period. 8. During screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant . 9. Taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug. 10. History of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission. 11. Presence of clinically significant ECG results judged by the investigator at screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC[0-∞] | 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 | through study completion, an average of 11 weeks | PK parameter of metformin, empagliflozin, midazolam, valsartan, and warfarin: Maximum observed concentration |
| AUC[0-t] | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK parameter of HDM1002 | through study completion, an average of 11 weeks | PK parameter of HDM1002 including Tmax, T1/2, CL/F, Vz/F, MRT, etc |
| other PK parameters | through study completion, an average of 11 weeks | Other PK parameters of metformin, empagliflozin, midazolam, valsartan, warfarin: Tmax, T1/2, CL/F, Vz/F, MRT, etc |
| Adverse events (AEs) | through study completion, an average of 11 weeks | Number of subjects reporting AEs |
Countries
China
Outcome results
None listed