A Drug-Drug Interaction (DDI) Study of HDM1002 With Rifampicin and Itraconazole in Healthy Subjects (NCT06562088) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Drug-Drug Interaction (DDI) Study of HDM1002 With Rifampicin and Itraconazole in Healthy Subjects
China40 participantsStarted 2024-08-16
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
. 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
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AUC[0-∞] of HDM1002
Timeframe: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
2
AUC[0-24 h] of HDM1002
Timeframe: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
3
Cmax of HDM1002
Timeframe: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
4
AUC[0-t] of HDM1002
Timeframe: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
5
Tmax of HDM1002
Timeframe: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
6
t1/2 of HDM1002
Timeframe: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
7
CL/F of HDM1002
Timeframe: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13
. 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.
8
Vz/F of HDM1002
Timeframe: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13