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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Adult Subject
• Intervention / Treatment: Drug: [14C] HDM1002

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Liyan Miao; Phone Number: 0512-67972858; Email: miaolysuzhou@163.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Recruiting
      • the First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C] HDM1002; A single dose of HDM1002 and [14C] HDM1002 administered orally.	Drug: [14C] HDM1002; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total recovery of HDM1002 radioactivity in urine and feces, following oral 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	Predose up to Day 11 after administration of [14C] HDM1002
Metabolite profiling/identification in plasma, urine, and feces	Metabolic profiling/identification and determination of relative abundance of [14C]PF-06882961 and the metabolites of [14C] HDM1002 in plasma, urine, and feces.	Predose up to Day 11 after administration of [14C] HDM1002
Plasma and whole blood AUC[0-t] of radioactivity	PK parameter : Area under the curve from time 0 to t hour	Predose up to Day 11 after administration of [14C] HDM1002
Plasma and whole blood AUC[0-∞] of radioactivity	PK parameter : Area under the curve from time 0 hour to ∞	Predose up to Day 11 after administration of [14C] HDM1002
Plasma and whole blood Cmax of radioactivity	PK parameter : Maximum observed concentration	Predose up to Day 11 after administration of [14C] HDM1002
Plasma and whole blood Tmax of radioactivity	PK parameter : Time to maximum plasma concentration	Predose up to Day 11 after administration of [14C] HDM1002
Plasma and whole blood t1/2 of radioactivity	PK parameter: Half life	Predose up to Day 11 after administration of [14C] HDM1002
Plasma and whole blood CL/F of radioactivity	PK parameter : Apparent Clearance	Predose up to Day 11 after administration of [14C] HDM1002
Plasma and whole blood Vz/F of radioactivity	PK parameter : Apparent volume of distribution	Predose up to Day 11 after administration of [14C] HDM1002
Percentage of plasma HDM1002 and metabolites in total plasma radioactivity	Percentage of plasma HDM1002 AUC in total plasma radioactivity AUC	Predose up to Day 11 after administration of [14C] HDM1002

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma AUC[0-t] of HDM1002 and metabolites	PK parameter : Area under the curve from time 0 to t hour	Predose up to Day 11 after administration of [14C] HDM1002
Plasma AUC[0-∞] of HDM1002 and metabolites	PK parameter : Area under the curve from time 0 hour to ∞	Predose up to Day 11 after administration of [14C] HDM1002
Plasma Cmax of HDM1002 and metabolites	PK parameter : Maximum observed concentration	Predose up to Day 11 after administration of [14C] HDM1002
Plasma Tmax of HDM1002 and metabolites	PK parameter : Time to maximum plasma concentration	Predose up to Day 11 after administration of [14C] HDM1002
Plasma t1/2 of HDM1002 and metabolites	PK parameter: Half life	Predose up to Day 11 after administration of [14C] HDM1002
Plasma CL/F of HDM1002 and metabolites	PK parameter : Apparent Clearance	Predose up to Day 11 after administration of [14C] HDM1002
Plasma Vz/F of HDM1002 and metabolites	PK parameter : Apparent volume of distribution	Predose up to Day 11 after administration of [14C] HDM1002
Adverse events (AEs)	Number of subjects reporting AEs	Predose up to Day 11 after administration of [14C] HDM1002

Collaborators and Investigators

• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: September 3, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Glucagon-Like Peptide-1 Receptor Agonists; HDM1002
• Other Study ID Numbers: HDM1002-104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No