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Recruiting NCT07331389

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

Phase I Interventional Overweight Subject Healthy Subjects

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Metformin, Empagliflozin, Midazolam, Valsartan.
Who it may be relevant to
Registry conditions: Overweight Subject, Healthy Subjects. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug Metformin
    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
  • Drug HDM1002
    Administered orally

Primary outcome measures

  • AUC[0-∞] [Time frame: through study completion, an average of 11 weeks]
  • Cmax [Time frame: through study completion, an average of 11 weeks]
  • AUC[0-t] [Time frame: through study completion, an average of 11 weeks]
Secondary outcome measures (3)
  • PK parameter of HDM1002 [Time frame: through study completion, an average of 11 weeks]
  • other PK parameters [Time frame: through study completion, an average of 11 weeks]
  • Adverse events (AEs) [Time frame: through study completion, an average of 11 weeks]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Affiliated Hospital of Anhui Medical University — Hefei

Identifiers

NCT: NCT07331389 · HDM1002-111

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗