Actively Recruiting
A Phase I Study to Evaluate Drug Interactions of HDM1002 with Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin in Overweight or Obese Adults
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2026-01-09
111
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the drug-drug interactions between HDM1002 and several commonly used medications, including metformin, empagliflozin, midazolam, valsartan, and warfarin, in overweight or obese adult subjects. The study aims to assess the safety and tolerability of these drugs when taken alone or together. This Phase I trial involves overweight or obese adults aged 18 to 45 years in good general health. Participants are grouped into two cohorts: one focusing on the interaction between HDM1002 and metformin or empagliflozin, and the other on interactions between HDM1002 and midazolam, valsartan, or warfarin. All drugs are administered orally, with some given as single doses. The study follows a fixed-sequence, open-label design conducted at a single center. Throughout the study, participants will be monitored for pharmacokinetic parameters such as drug concentration over time (AUC and Cmax) over an average of 11 weeks. Safety assessments include recording adverse events and clinical evaluations like vital signs, ECGs, and laboratory tests. The study ensures thorough observation of how these drugs interact and affect the body during the trial period.
CONDITIONS
Brief Title
A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between 18 and 45 years old
- Be in good general health based on medical history, lab tests, vital signs, ECG, and physical exam
- Weigh at least 50.0 kg
- Have a body mass index (BMI) between 24.0 and 35.0 kg/m2
You will not qualify if you...
- History or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, multiple endocrine neoplasia type 2 (MEN2), or calcitonin level 6550 ng/L
- History of chronic pancreatitis or acute pancreatitis within 3 months before screening
- History of acute cholecystitis attack within 3 months before screening
- Severe or recurrent hypoglycemic events within 3 months before screening
- Conditions affecting swallowing or gastrointestinal absorption such as bariatric surgery, gastrectomy, irritable bowel syndrome, or dyspepsia
- Pre-existing conditions increasing bleeding risk, including active ulcers, cerebral or intracranial hemorrhage
- Previous or planned surgery affecting drug absorption, metabolism, or excretion during the study
- Clinically significant abnormalities in physical exam, ECG, lab tests, or vital signs during screening
- Use or planned use of drugs affecting liver enzymes or transporters within 28 days before taking the study drug
- Significant cardiovascular or cerebrovascular disease within 6 months prior to screening
- Clinically significant ECG abnormalities at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 11 weeks
Participants receive single doses of HDM1002 and other study drugs to evaluate drug interactions.
Multiple visits over the course of the treatment period
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Anhui Medical University
Hefei, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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