A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin

Hangzhou Zhongmei Huadong Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Healthy Subjects; Overweight Subject

Treatments: Drug: Warfarin; Drug: Midazolam; Drug: HDM1002; Drug: Metformin; Drug: Valsartan; Drug: Empagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT07331389

HDM1002-111

Details and patient eligibility

About

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

Enrollment: 111 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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111 participants in 1 patient group

experimental arm

Experimental group

Description:

Cohort 1 (Study on the Interaction between HDM1002 and Metformin, empagliflozin), Cohort 2 (Study on the Interaction between HDM1002 and Midazolam, valsartan, Warfarin)

Treatment:

Drug: Empagliflozin

Drug: Valsartan

Drug: Metformin

Drug: HDM1002

Drug: Warfarin

Drug: Midazolam