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 range18 Years – 45 Years

SexMALE

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;
✕. 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;

What they're measuring

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

Metabolite profiling/identification in plasma, urine, and feces

Timeframe: Predose up to Day 11 after administration of [14C] HDM1002

Plasma and whole blood AUC[0-t] of radioactivity

Timeframe: Predose up to Day 11 after administration of [14C] HDM1002

Plasma and whole blood AUC[0-∞] of radioactivity

Timeframe: Predose up to Day 11 after administration of [14C] HDM1002

Plasma and whole blood Cmax of radioactivity

Timeframe: Predose up to Day 11 after administration of [14C] HDM1002

Plasma and whole blood Tmax of radioactivity

Timeframe: Predose up to Day 11 after administration of [14C] HDM1002

Plasma and whole blood t1/2 of radioactivity

Timeframe: Predose up to Day 11 after administration of [14C] HDM1002

Trial details

NCT IDNCT06576401

SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10

Contact for this trial

Liyan Miao

0512-67972858 miaolysuzhou@163.com

View on ClinicalTrials.gov More Healthy Adult Subject trials

Plain-language summary

Who can participate

Age range18 Years – 45 Years

SexMALE

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;
✕. 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;

What they're measuring

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

Metabolite profiling/identification in plasma, urine, and feces

Timeframe: Predose up to Day 11 after administration of [14C] HDM1002

Plasma and whole blood AUC[0-t] of radioactivity

Timeframe: Predose up to Day 11 after administration of [14C] HDM1002

Plasma and whole blood AUC[0-∞] of radioactivity

Timeframe: Predose up to Day 11 after administration of [14C] HDM1002

Plasma and whole blood Cmax of radioactivity

Timeframe: Predose up to Day 11 after administration of [14C] HDM1002

Plasma and whole blood Tmax of radioactivity

Timeframe: Predose up to Day 11 after administration of [14C] HDM1002

Plasma and whole blood t1/2 of radioactivity

Timeframe: Predose up to Day 11 after administration of [14C] HDM1002