Healthy Adult Subject
Conditions
Keywords
HDM1002 tablet, Glucagon-Like Peptide-1 Receptor Agonists
Brief summary
The purpose of this study is to characterize the effect of rifampicin and itraconazole on the PK of single dose of HDM1002 in healthy adult subjects. The safety and tolerability of HDM1002 and rifampicin or itraconazole when given separately or together will also be evaluated.
Interventions
DRUGHDM1002 and rifampicin
Administered orally
DRUGHDM1002 and itraconazole
Administered orally
Sponsors
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
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. Eligible male participant weighed ≥50.0 kg, eligible female participant weighed ≥45.0 kg, and had a body mass index (BMI) within the range of 19.0 - 32.0 kg/m2 (including cut-off values).
Exclusion criteria
1. Participant 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 within 3 month prior to initiation of screening period. 4. Participant 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 |
|---|---|---|
| AUC[0-∞] of HDM1002 | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 | Pharmacokinetics (PK) parameter : Area under the curve from time 0 hour to ∞ |
| AUC[0-24 h] of HDM1002 | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 | PK parameter : Area under the curve from time 0 to 24 hour |
| Cmax of HDM1002 | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 | PK parameter : Maximum observed concentration |
| AUC[0-t] of HDM1002 | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 | PK parameters : Area under the curve from time 0 to t hour |
| Tmax of HDM1002 | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 | PK parameters : Time to maximum plasma concentration |
| t1/2 of HDM1002 | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 | PK parameters : Half life |
| CL/F of HDM1002 | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 | PK parameters : Apparent Clearance |
| Vz/F of HDM1002 | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 | PK parameters : Apparent volume of distribution |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC[0-∞] of HDM1002 metabolites | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 | PK parameters : Area under the curve from time 0 hour to ∞ |
| Adverse events (AEs) | Cohort 1: Day 1-Day 16; Cohort 2: Day 1-Day 13 | Number of subjects reporting AEs |
| AUC[0-24 h] of HDM1002 metabolites | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 | PK parameters : Area under the curve from time 0 to 24 hour |
| Cmax of HDM1002 metabolites | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 | PK parameters : Maximum observed concentration |
| AUC[0-t] of HDM1002 metabolites | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 | PK parameters : Area under the curve from time 0 to t hour |
| Tmax of HDM1002 metabolites | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 | PK parameters : Time to maximum plasma concentration |
| t1/2 of HDM1002 metabolites | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 | PK parameters: Half life |
| CL/F of HDM1002 metabolites | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 | PK parameters : Apparent Clearance |
| Vz/F of HDM1002 metabolites | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 | PK parameters : Apparent volume of distribution |
Countries
China
Contacts
Primary ContactWei hu
Outcome results
None listed