Overweight or Obese
Conditions
Brief summary
The purpose of the study is to evaluate the influence of BGM0504 injection on gastric emptying and Pharmacokinetics of metformin and warfarin in overweight or obese participants
Interventions
DRUGParacetamol
oral, postprandial
DRUGMetformin Hydrochloride
Oral , Fasting
DRUGWarfarin
Oral , Fasting
DRUGBGM0504
Administered SC
Sponsors
BrightGene Bio-Medical Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
√ Have a body mass index (BMI) of greater than or equal to (≥)28 kilogram per square meter (kg/m²) or ≥24 kg/m2 and less than (\<) 28 kg/m². √ Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff.
Exclusion criteria
√ History of chronic or acute pancreatitis. * History of severe drug allergy or specific allergic disease or severe allergies. * Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2(MEN-2). * History of malignant tumors \[except carcinoma in situ with no recurrence within 5 years (except for malignant melanoma in situ), skin basal cell carcinoma and squamous cell carcinoma\]. * Suspected or confirmed history of alcohol or drug abuse; * Any chronic infections likely to interfere with study conduct or interpretation such as hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP). * Donation or loss of 400 mL or more of blood within 3 months prior to screening, or blood donation during screening or within 3 months after the end of the trial. * Pregnant or lactating woman. * Any disorder, unwillingness, or inability not covered by any of the other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Warfarin | From Day7 to Day84 | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Warfarin |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Metformin | From Day4 to Day76 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t)of Metformin |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin | From Day4 to Day76 | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Warfarin | From Day7 to Day84 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Warfarin |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t)of Paracetamol | From Day1 to Day72 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Paracetamol |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Paracetamol | From Day1 to Day72 | Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax) of Paracetamol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Maximum Concentration (Tmax) of Metformin and Warfarin | From Day1 to Day84 | Time to Maximum Concentration (Tmax) of Metformin and Warfarin |
| Terminal Half-life (t1/2) of Paracetamol | From Day1 to Day72 | Terminal Half-life (t1/2) of Paracetamol |
| Area Under the Stable-State Concentration Versus Time Curve (AUC0-∞,ss ) of BGM0504 | From Day14 to Day69 | Area Under the Stable-State Concentration Versus Time Curve (AUC0-∞,ss ) of BGM0504 |
Countries
China
Outcome results
None listed