A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and … (NCT07331389) | Clinical Trial Compass
RecruitingPhase 1
A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin
China111 participantsStarted 2025-09-24
Plain-language 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
Who can participate
Age range18 Years – 45 Years
SexALL
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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
What they're measuring
1
AUC[0-∞]
Timeframe: through study completion, an average of 11 weeks
2
Cmax
Timeframe: through study completion, an average of 11 weeks
3
AUC[0-t]
Timeframe: through study completion, an average of 11 weeks
. 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 .