Influence of HDM1005 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

About this trial

The purpose of this study is to characterize the Influence of HDM1005 on gastric emptying and drug-drug interaction of HDM1005 and metformin, atorvastatin, warfarin, and digoxin in overweight/obese adult subjects.

Eligibility criteria

Qualifiers

Aged between 18 and 45 years (inclusive), regardless of gender.

Male participants with body weight ≥50.0 kg, female participants with body weight ≥45.0 kg, and body mass index (BMI = weight [kg]/height² [m²]) within the range of 24.0 to 35.0 kg/m² (inclusive).

In the opinion of the investigator, participants are in generally good health based on medical history, clinical laboratory tests, vital signs, 12-lead ECG results, and physical examination findings at screening.

Provide signed informed consent form (ICF) prior to the trial, and have a thorough understanding of the trial content, procedures, and possible adverse reactions. Participants must be able to communicate well with the investigator, and understand and comply with the requirements of this study.

Disqualifiers

Participants with a medical history or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).

History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.

History of an acute episode of cholecystitis within 3 months prior to screening.

Experienced severe hypoglycemic events or recurrent hypoglycemic events (≥3 hypoglycemic events per week, or other hypoglycemic events as judged by the investigator) within 3 months prior to screening.

Trial design

Treatments tested in this trial

  • Acetaminophen
  • Metformin
  • Warfarin
  • Atorvastatin
  • Digoxin
  • HDM1005 injection

Treatment groups

42 Participants
are divided into 1 treatment group