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.
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.
Age range of 18-45 years old (including range), no limit to gender.
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).
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.
History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
History of acute cholecystitis attack within 3 months prior to screening.
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.
Single group
Repaglinide
DrugSingle dose; Administered orally
Atorvastatin
DrugSingle dose; Administered orally
Digoxin
DrugSingle dose; Administered orally
Rosuvastatin
DrugSingle dose; Administered orally
HDM1002
DrugAdministered orally
AUC[0-∞]
Pharmacokinetics (PK) parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Area under the curve from time 0 hour to ∞
AUC[0-t]
PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Area under the curve from time 0 to t hour
Cmax
PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Maximum observed concentration
Tmax
PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Time to maximum plasma concentration
t1/2
PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Half life
CL/F
PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Apparent Clearance
Vz/F
PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Apparent volume of distribution
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
