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

NCT06576401 | Recruiting Phase 1 FDA Drug

• 1 other identifier: HDM1002-104
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adult Subject

Keywords

HDM1002; Glucagon-Like Peptide-1 Receptor Agonists

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (8)

• Plasma AUC[0-t] of HDM1002 and metabolites

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

• Plasma AUC[0-∞] of HDM1002 and metabolites

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

• Plasma Cmax of HDM1002 and metabolites

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

• Plasma Tmax of HDM1002 and metabolites

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

• Plasma t1/2 of HDM1002 and metabolites

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

Study Arms (1)

[14C] HDM1002

EXPERIMENTAL

A single dose of HDM1002 and \[14C\] HDM1002 administered orally.

Drug: [14C] HDM1002

Interventions

[14C] HDM1002 DRUG

Administered orally

[14C] HDM1002

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• History of drug abuse (e.g., morphine, ketamine, tetrahydrocannabinolic acid, metham phetamine, methylenedioxyamphetamine, cocaine) or positive urine drug test during the screening period;
• 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.
• 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;

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

RECRUITING

Central Study Contacts

Liyan Miao

CONTACT

0512-67972858; miaolysuzhou@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 28, 2024
• Study Start: August 27, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-09

Locations

CN (1)