A Study To Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects (NCT06576401) | Clinical Trial Compass
RecruitingPhase 1
A Study To Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects
China10 participantsStarted 2024-08-27
Plain-language summary
In this study, a single dose of \[14C\] radiolabelled HDM1002 will be administered orally. The main purpose of this study is to find out how much of HDM1002 and its metabolites pass from blood into urine and feces, and characterize the metabolic profile and routes of excretion of oral \[14C\] HDM002.
Who can participate
Age range
18 Years – 45 Years
Sex
MALE
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
. Male, healthy adult;
. Age of 18 to 45 years old (both inclusive);
. Body mass index (BMI) between 19.0- 32.0 kg/m2 (both inclusive) and body weight no less than 50.0 kg.
Exclusion criteria
. Clinically significant diseases at the time of screening;
. History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin ≥ 35 ng/L during the screening period;
. History of chronic pancreatitis or acute pancreatitis within 3 months prior to screening;
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
Total recovery of HDM1002 radioactivity in urine and feces, following oral administration of [14C] HDM1002
Timeframe: Predose up to Day 11 after administration of [14C] HDM1002
2
Metabolite profiling/identification in plasma, urine, and feces
Timeframe: Predose up to Day 11 after administration of [14C] HDM1002
3
Plasma and whole blood AUC[0-t] of radioactivity
Timeframe: Predose up to Day 11 after administration of [14C] HDM1002
4
Plasma and whole blood AUC[0-∞] of radioactivity
Timeframe: Predose up to Day 11 after administration of [14C] HDM1002
5
Plasma and whole blood Cmax of radioactivity
Timeframe: Predose up to Day 11 after administration of [14C] HDM1002
6
Plasma and whole blood Tmax of radioactivity
Timeframe: Predose up to Day 11 after administration of [14C] HDM1002
. History of acute cholecystitis attack within 3 months prior to screening;
. Participant judged by investigator has dysphagia, diseases or conditions that affect gastric emptying or affect the absorption of nutrients in the gastrointestinal tract, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.;
. Any of the following: habitual constipation or diarrhea, hemorrhoids or accompanied by perianal disease, irritable bowel syndrome, inflammatory bowel disease, etc;
. Use of any prescription medication, over-the-counter medication, Chinese herbal medicine or food supplement within 14 days or 5 half-lives (whichever is longer) prior to the screening period;
. Patients with any abnormal and clinically significant examinations in given comprehensive physical examination;
Timeframe: Predose up to Day 11 after administration of [14C] HDM1002
8
Plasma and whole blood CL/F of radioactivity
Timeframe: Predose up to Day 11 after administration of [14C] HDM1002
9
Plasma and whole blood Vz/F of radioactivity
Timeframe: Predose up to Day 11 after administration of [14C] HDM1002
10
Percentage of plasma HDM1002 and metabolites in total plasma radioactivity
Timeframe: Predose up to Day 11 after administration of [14C] HDM1002