Phase I Study to Evaluate Drug Interactions of HDM1002 with Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin in Overweight or Obese Adults Aged 18 to 45

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.

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