A Drug-Drug Interaction (DDI) Study of HDM1002 With Rifampicin and Itraconazole in Healthy Subjects
- Conditions
- Healthy Adult Subject
- Interventions
- Registration Number
- NCT06562088
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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).
- 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.
- History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
- History of acute cholecystitis within 3 month prior to initiation of screening period.
- 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.
- 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
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2: HDM1002 and itraconazole HDM1002 and itraconazole Part 1: Single dose of HDM1002 Part 2: Once daily dose of itraconazole with single dose of HDM1002 Cohort 1: HDM1002 and rifampicin HDM1002 and rifampicin Part 1: Single dose of HDM1002 Part 2: Once daily dose of rifampicin with single dose of HDM1002
- Primary Outcome Measures
Name Time Method 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
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 ∞
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
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
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
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
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
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 Outcome Measures
Name Time Method 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
Adverse events (AEs) Cohort 1: Day 1-Day 16; Cohort 2: Day 1-Day 13 Number of subjects reporting AEs
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 ∞
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[0-24 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
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
Trial Locations
- Locations (1)
The second hospital of anhui medical university
🇨🇳Hefei, Anhui, China
The second hospital of anhui medical university🇨🇳Hefei, Anhui, China