Healthy Adult Subject
Conditions
Keywords
HDM1002, Glucagon-Like Peptide-1 Receptor Agonists
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.
Interventions
DRUG[14C] HDM1002
Administered orally
Sponsors
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of plasma HDM1002 and metabolites in total plasma radioactivity | Predose up to Day 11 after administration of [14C] HDM1002 | Percentage of plasma HDM1002 AUC in total plasma radioactivity AUC |
| Metabolite profiling/identification in plasma, urine, and feces | Predose up to Day 11 after administration of [14C] HDM1002 | Metabolic profiling/identification and determination of relative abundance of \[14C\]PF-06882961 and the metabolites of \[14C\] HDM1002 in plasma, urine, and feces. |
| Plasma and whole blood AUC[0-t] of radioactivity | Predose up to Day 11 after administration of [14C] HDM1002 | PK parameter : Area under the curve from time 0 to t hour |
| Plasma and whole blood AUC[0-∞] of radioactivity | Predose up to Day 11 after administration of [14C] HDM1002 | PK parameter : Area under the curve from time 0 hour to ∞ |
| Plasma and whole blood Cmax of radioactivity | Predose up to Day 11 after administration of [14C] HDM1002 | PK parameter : Maximum observed concentration |
| Plasma and whole blood Tmax of radioactivity | Predose up to Day 11 after administration of [14C] HDM1002 | PK parameter : Time to maximum plasma concentration |
| Plasma and whole blood t1/2 of radioactivity | Predose up to Day 11 after administration of [14C] HDM1002 | PK parameter: Half life |
| Plasma and whole blood CL/F of radioactivity | Predose up to Day 11 after administration of [14C] HDM1002 | PK parameter : Apparent Clearance |
| Plasma and whole blood Vz/F of radioactivity | Predose up to Day 11 after administration of [14C] HDM1002 | PK parameter : Apparent volume of distribution |
| Total recovery of HDM1002 radioactivity in urine and feces, following oral administration of [14C] HDM1002 | Predose up to Day 11 after administration of [14C] HDM1002 | Total recovery of radioactivity in urine and feces, and both routes combined expressed as a percentage of the total radioactive dose administered |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma AUC[0-∞] of HDM1002 and metabolites | Predose up to Day 11 after administration of [14C] HDM1002 | PK parameter : Area under the curve from time 0 hour to ∞ |
| Plasma Cmax of HDM1002 and metabolites | Predose up to Day 11 after administration of [14C] HDM1002 | PK parameter : Maximum observed concentration |
| Plasma Tmax of HDM1002 and metabolites | Predose up to Day 11 after administration of [14C] HDM1002 | PK parameter : Time to maximum plasma concentration |
| Plasma t1/2 of HDM1002 and metabolites | Predose up to Day 11 after administration of [14C] HDM1002 | PK parameter: Half life |
| Plasma CL/F of HDM1002 and metabolites | Predose up to Day 11 after administration of [14C] HDM1002 | PK parameter : Apparent Clearance |
| Plasma Vz/F of HDM1002 and metabolites | Predose up to Day 11 after administration of [14C] HDM1002 | PK parameter : Apparent volume of distribution |
| Adverse events (AEs) | Predose up to Day 11 after administration of [14C] HDM1002 | Number of subjects reporting AEs |
| Plasma AUC[0-t] of HDM1002 and metabolites | Predose up to Day 11 after administration of [14C] HDM1002 | PK parameter : Area under the curve from time 0 to t hour |
Countries
China
Contacts
Primary ContactLiyan Miao
Outcome results
None listed