Characterizing how HDM1002 is processed in healthy adults

A Phase1 Study to Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects

This study is testing how a new drug called HDM1002 is processed and eliminated from the body in healthy young men.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Male
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT06576401 on ClinicalTrials.gov

What this trial studies

This study involves administering a single oral dose of [14C] radiolabeled HDM1002 to healthy male adults aged 18 to 45. The primary aim is to analyze how much of the drug and its metabolites are excreted through urine and feces, thereby characterizing the metabolic profile and excretion routes of HDM1002. Participants will be monitored for their metabolic responses to the drug to gather data on its pharmacokinetics.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy male adults aged 18 to 45 with a BMI between 19.0 and 32.0 kg/m2.

Not a fit: Patients with significant underlying health conditions or a history of certain endocrine disorders will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the metabolism of HDM1002, potentially leading to improved therapeutic strategies for conditions treated by glucagon-like peptide-1 receptor agonists.

How similar studies have performed: While this specific approach may be novel, similar studies investigating the pharmacokinetics of drugs have shown success in understanding drug metabolism.

Eligibility criteria

Inclusion Criteria:

1. Male, healthy adult;
2. Age of 18 to 45 years old (both inclusive);
3. Body mass index (BMI) between 19.0- 32.0 kg/m2 (both inclusive) and body weight no less than 50.0 kg.

Exclusion Criteria:

1. Clinically significant diseases at the time of screening;
2. 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;
3. History of chronic pancreatitis or acute pancreatitis within 3 months prior to screening;
4. History of acute cholecystitis attack within 3 months prior to screening;
5. 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.;
6. Any of the following: habitual constipation or diarrhea, hemorrhoids or accompanied by perianal disease, irritable bowel syndrome, inflammatory bowel disease, etc;
7. 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;
8. Patients with any abnormal and clinically significant examinations in given comprehensive physical examination;
9. History of drug abuse (e.g., morphine, ketamine, tetrahydrocannabinolic acid, metham phetamine, methylenedioxyamphetamine, cocaine) or positive urine drug test during the screening period;
10. Positive for hepatitis B surface antigen or E antigen, hepatitis C virus antibody IgG (Anti-HCV IgG), human immunodeficiency virus antigen/antibody combination test (HIV-Ag/Ab) and Treponema pallidum antibody during the screening period.
11. Engaged in working conditions requiring long-term exposure to radioactivity; or significant radioactive exposure ( ≥ 2 CT chest/abdomen tests, or ≥ 3 all other types of X-rays test) within 1 year prior to the trail, or participated in radio-label trails;

Where this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Liyan Miao

Conditions Healthy Adult Subject; HDM1002; Glucagon-Like Peptide-1 Receptor Agonists