Obesity, Overweight
Conditions
Brief summary
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.
Interventions
DRUGAcetaminophen
Single dose; Administered orally
DRUGMetformin
Single dose; Administered orally
DRUGWarfarin
Single dose; Administered orally
DRUGAtorvastatin
Single dose; Administered orally
DRUGDigoxin
Single dose; Administered orally
DRUGHDM1005 injection
Subcutaneous injection QW
Sponsors
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Blood donation, significant blood loss (≥400 mL), or use of blood products within 3 months prior to screening or between screening and the first dose. * Use of prescription or over-the-counter medications, health supplements, or herbal medicines within 2 weeks prior to IMP administration, or still within 5 half-lives of such medications, whichever is longer (excluding contraceptives). * Participation in any clinical trial and use of investigational product within 3 months prior to screening, or still within 5 half-lives of the investigational product from a previous trial at the time of screening (whichever is longer). * Female participants who are breastfeeding or pregnant. * Participants with any other factors that, in the opinion of the investigator, make them unsuitable for participation in this trial (e.g., medical, psychological, or psychiatric conditions, social or geographical factors)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration Time Curve From Time Zero to ∞ [ AUC(0- ∞)] | Up to Day 115 | PK parameter of Metformin, Atorvastatin, Warfarin, and Digoxin: Area under the curve from time 0 hour to ∞ |
| Maximum observed concentration (Cmax) | Up to Day 115 | PK parameter of Acetaminophen, Metformin, Atorvastatin, Warfarin, and Digoxin: Maximum observed concentration |
| Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)] | Up to Day 115 | PK parameter of Acetaminophen, Metformin, Atorvastatin, Warfarin, and Digoxin: Area under the curve from time 0 hour to t |
| Time of maximum observed concentration (Tmax) | Up to Day 115 | PK parameter of Acetaminophen: Time of maximum observed concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) | Up to Day 115 | Number of subjects reporting AEs |
| Apparent volume of distribution (Vz/F) | Up to Day 115 | PK parameter of Acetaminophen, Metformin, Atorvastatin, Warfarin, and Digoxin |
| Time of maximum observed concentration (Tmax) | Up to Day 115 | PK parameter of HDM1005, Metformin, Atorvastatin, Warfarin, and Digoxin |
| Maximum observed concentration (Cmax) | Up to Day 115 | PK parameter of HDM1005 |
| Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)] | Up to Day 115 | PK parameter of HDM1005 |
Countries
China
Outcome results
None listed