Clinical trial NCT06576401: A Study To Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects
Official title: A Phase1 Study to Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Adult Subject
Keywords: HDM1002
Glucagon-Like Peptide-1 Receptor Agonists
Lead sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-28
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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;

Primary outcomes:
measure: 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
measure: Metabolite profiling/identification in plasma, urine, and feces
timeFrame: Predose up to Day 11 after administration of [14C] HDM1002
measure: Plasma and whole blood AUC[0-t] of radioactivity
timeFrame: Predose up to Day 11 after administration of [14C] HDM1002
measure: Plasma and whole blood AUC[0-∞] of radioactivity
timeFrame: Predose up to Day 11 after administration of [14C] HDM1002
measure: Plasma and whole blood Cmax of radioactivity
timeFrame: Predose up to Day 11 after administration of [14C] HDM1002
measure: Plasma and whole blood Tmax of radioactivity
timeFrame: Predose up to Day 11 after administration of [14C] HDM1002
measure: Plasma and whole blood t1/2 of radioactivity
timeFrame: Predose up to Day 11 after administration of [14C] HDM1002
measure: Plasma and whole blood CL/F of radioactivity
timeFrame: Predose up to Day 11 after administration of [14C] HDM1002
measure: Plasma and whole blood Vz/F of radioactivity
timeFrame: Predose up to Day 11 after administration of [14C] HDM1002
measure: Percentage of plasma HDM1002 and metabolites in total plasma radioactivity
timeFrame: Predose up to Day 11 after administration of [14C] HDM1002
Secondary outcomes:
measure: Plasma AUC[0-t] of HDM1002 and metabolites
timeFrame: Predose up to Day 11 after administration of [14C] HDM1002
measure: Plasma AUC[0-∞] of HDM1002 and metabolites
timeFrame: Predose up to Day 11 after administration of [14C] HDM1002
measure: Plasma Cmax of HDM1002 and metabolites
timeFrame: Predose up to Day 11 after administration of [14C] HDM1002
measure: Plasma Tmax of HDM1002 and metabolites
timeFrame: Predose up to Day 11 after administration of [14C] HDM1002
measure: Plasma t1/2 of HDM1002 and metabolites
timeFrame: Predose up to Day 11 after administration of [14C] HDM1002
measure: Plasma CL/F of HDM1002 and metabolites
timeFrame: Predose up to Day 11 after administration of [14C] HDM1002
measure: Plasma Vz/F of HDM1002 and metabolites
timeFrame: Predose up to Day 11 after administration of [14C] HDM1002
measure: Adverse events (AEs)
timeFrame: Predose up to Day 11 after administration of [14C] HDM1002
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
References: