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

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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Subjects; Overweight Subject
• Intervention / Treatment: Drug: Metformin; Drug: HDM1002; Drug: Empagliflozin; Drug: Midazolam; Drug: Valsartan; Drug: Warfarin

• Study Type: Interventional
• Enrollment (Estimated): 111
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hefei, China
    • Recruiting
    • The Second Affiliated Hospital of Anhui Medical University
    • Contact: Yan Gao Ms; Phone Number: +86-0571-89918267; Email: cxygaoyan@eastchinapharm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: Metformin; Administered orally; Drug: HDM1002; Administered orally; Drug: Empagliflozin; Single dose; Administered orally; Drug: Midazolam; Single dose; Administered orally; Drug: Valsartan; Single dose; Administered orally; Drug: Warfarin; Single dose; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC[0-∞]	PK parameter of metformin, empagliflozin, midazolam, valsartan, and warfarin:Area under the curve from time 0 hour to ∞	through study completion, an average of 11 weeks
Cmax	PK parameter of metformin, empagliflozin, midazolam, valsartan, and warfarin: Maximum observed concentration	through study completion, an average of 11 weeks
AUC[0-t]	PK parameter of metformin, empagliflozin, midazolam, valsartan, and warfarin: Area under the curve from time 0 to t hour	through study completion, an average of 11 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameter of HDM1002	PK parameter of HDM1002 including Tmax, T1/2, CL/F, Vz/F, MRT, etc	through study completion, an average of 11 weeks
other PK parameters	Other PK parameters of metformin, empagliflozin, midazolam, valsartan, warfarin: Tmax, T1/2, CL/F, Vz/F, MRT, etc	through study completion, an average of 11 weeks
Adverse events (AEs)	Number of subjects reporting AEs	through study completion, an average of 11 weeks

Collaborators and Investigators

• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2025
• Primary Completion (Estimated): January 12, 2026
• Study Completion (Estimated): June 13, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: HDM1002
• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrans; Azoles; Amino Acids; Benzazepines; Amino Acids, Essential; Biguanides; Guanidines; Amidines; Coumarins; Benzopyrans; Benzodiazepines; Tetrazoles; 4-Hydroxycoumarins; Valine; Amino Acids, Branched-Chain; Valsartan; Midazolam; Metformin; Warfarin; empagliflozin
• Other Study ID Numbers: HDM1002-111

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No