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

NCT ID: NCT07331389

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-24
• Study Completion Date: 2026-06-13

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

Conditions

Overweight Subject; Healthy Subjects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Administered orally

Empagliflozin

Intervention Type: DRUG

Single dose; Administered orally

Midazolam

Intervention Type: DRUG

Single dose; Administered orally

Valsartan

Intervention Type: DRUG

Single dose; Administered orally

Warfarin

Intervention Type: DRUG

Single dose; Administered orally

HDM1002

Intervention Type: DRUG

Administered orally

Interventions

Metformin

Administered orally

Intervention Type: DRUG

Empagliflozin

Single dose; Administered orally

Intervention Type: DRUG

Midazolam

Single dose; Administered orally

Intervention Type: DRUG

Valsartan

Single dose; Administered orally

Intervention Type: DRUG

Warfarin

Single dose; Administered orally

Intervention Type: DRUG

HDM1002

Administered orally

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital of Anhui Medical University

Hefei, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yan Gao Ms

Role: primary

cxygaoyan@eastchinapharm.com

+86-0571-89918267

Other Identifiers

HDM1002-111

Identifier Type: -

Identifier Source: org_study_id