A Relative Bioavailability and Food Effect Study of HDM1002 in Healthy Subjects
- Registration Number
- NCT06608329
- Brief Summary
The main purpose of this study is to evaluate the effect of formulation on relative bioavailability of HDM1002, and the food effect on pharmacokinetics of HDM1002.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
- 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).
- Female subject of childbearing potentiaafter last dose, who have no childbearing plans and agrl during signature ICF to 30 days after last dose and male subject during signature ICF to 90 days ee to use highly effective contraception and consent not to donate sperm and oocyte during this period.
Exclusion Criteria
- 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.
- History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period.
- During screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant .
- Taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug.
- History of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission.
- Presence of clinically significant ECG results judged by the investigator at screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort 1 HDM1002 Period 1: Subjects received HDM1002 table (200 mg×1）in fasted state; Period 2: Subjects received HDM1002 tables (100 mg×2）in fasted state; Period 3: Subjects received HDM1002 table (200 mg×1）in fed state. Cohort 2 HDM1002 Period 1: Subjects received HDM1002 tables (100 mg×2）in fasted state; Period 2: Subjects received HDM1002 table (200 mg×1）in fed state; Period 3: Subjects received HDM1002 table (200 mg×1）in fasted state. Cohort 3 HDM1002 Period 1: Subjects received HDM1002 table (200 mg×1）in fed state; Period 2: Subjects received HDM1002 table (200 mg×1）in fasted state; Period 3: Subjects received HDM1002 tables (100 mg×2）in fasted state.
- Primary Outcome Measures
Name Time Method AUC[0-∞] Day1-Day17 Area under the curve from time 0 hour to ∞
AUC[0-t] Day1-Day17 Area under the curve from time 0 to t hour
Cmax Day1-Day17 Maximum observed concentration
Tmax Day1-Day17 Time to maximum plasma concentration
t1/2 Day1-Day17 Half life
CL/F Day1-Day17 Apparent Clearance
Vz/F Day1-Day17 Apparent volume of distribution
F Day1-Day17 Relative Bioavailability
- Secondary Outcome Measures
Name Time Method Adverse events (AEs) Day1-Day17 Number of subjects reporting AEs
Trial Locations
- Locations (1)
Hangzhou First People's Hospital
🇨🇳Hangzhou, Zhejiang, China