Healthy Adult Subject, Overweight Subject
Conditions
Keywords
HDM1002, Glucagon-Like Peptide-1 Receptor Agonists
Brief summary
The purpose of this study is to characterize the effect of HDM1002 on the PK of single dose of repaglinide, atorvastatin, digoxin and rosuvastatin in healthy adult subjects. The safety and tolerability of HDM1002 with repaglinide, atorvastatin, digoxin and rosuvastatin when given separately or together will also be evaluated.
Interventions
DRUGRepaglinide
Single dose; Administered orally
DRUGAtorvastatin
Single dose; Administered orally
DRUGDigoxin
Single dose; Administered orally
DRUGRosuvastatin
Single dose; Administered orally
DRUGHDM1002
Administered orally
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
1. According to the medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination results during the screening period, the investigator considers the subject to be in good general health. 2. Age range of 18-45 years old (including range), no limit to gender. 3. Male subject weighed ≥50.0 kg, female subject weighed ≥45.0 kg, and a body mass index (BMI) within the range of 19.0 - 30.0 kg/m2 (including cut-off values).
Exclusion criteria
1. Subject has a history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin≥50 ng/L during the screening period. 2. History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening. 3. History of acute cholecystitis attack within 3 months prior to screening. 4. Subject judged by investigator has dysphagia, diseases or conditions that affect gastric emptying, or affect the absorption of gastrointestinal nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc. 5. History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period. 6. During screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant . 7. Taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug. 8. History of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission. 9. Presence of clinically significant ECG results judged by the investigator at screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Period 1 and Period 3: Day 1-Day 16 | PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Maximum observed concentration |
| AUC[0-∞] | Period 1 and Period 3: Day 1-Day 16 | Pharmacokinetics (PK) parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Area under the curve from time 0 hour to ∞ |
| AUC[0-t] | Period 1 and Period 3: Day 1-Day 16 | PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Area under the curve from time 0 to t hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vz/F | Period 1 and Period 3: Day 1-Day 16 | PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Apparent volume of distribution |
| Tmax | Period 1 and Period 3: Day 1-Day 16 | PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Time to maximum plasma concentration |
| Adverse events (AEs) | Period 1 and Period 3: Day 1-Day 16, Period 2: Day 1-Day 35 | Number of subjects reporting AEs |
| t1/2 | Period 1 and Period 3: Day 1-Day 16 | PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Half life |
| CL/F | Period 1 and Period 3: Day 1-Day 16 | PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Apparent Clearance |
Countries
China
Contacts
Primary ContactCheng Cui
Outcome results
None listed