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

NCT07331389 | Recruiting Phase 1 FDA Drug

• 1 other identifier: HDM1002-111
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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

Keywords

HDM1002

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (1)

experimental arm

EXPERIMENTAL

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

Interventions

Metformin DRUG

Administered orally

experimental arm

Empagliflozin DRUG

Single dose; Administered orally

experimental arm

Midazolam DRUG

Single dose; Administered orally

experimental arm

Valsartan DRUG

Single dose; Administered orally

experimental arm

HDM1002 DRUG

Administered orally

experimental arm

Warfarin DRUG

Single dose; Administered orally

experimental arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, China

RECRUITING

MeSH Terms

Interventions

Metformin; empagliflozin; Midazolam; Valsartan; Warfarin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: January 9, 2026
• Study Start: September 24, 2025
• Primary Completion: January 12, 2026
• Study Completion (Estimated): June 13, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-12

Locations

CN (1)