GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT06576401

RecruitingPhase 1

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

Lead sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Asset

HDM1002

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Healthy volunteers

Key I/E criteria

•BMI 19-32•Male•Healthy volunteers

Primary endpoints

•Total recovery of HDM1002 radioactivity in urine and feces (urine radioactivity recovery, feces radioactivity recovery)•Metabolite profiling/identification in plasma, urine, and feces•Plasma and whole blood AUC[0-t] of radioactivity

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06576401

Org study IDHDM1002-104

Timeline

Milestones

Study start2024-08-27actual

Study first posted2024-08-28actual

Last update posted2024-09-04actual

Primary completion2024-10estimated (month precision)

Study completion2024-12estimated (month precision)

Assets

Investigational agents

HDM1002

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexMale

Healthy volunteersAccepted

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;

Endpoints (18)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

18 endpoints

Primary/protocol endpoint

Total recovery of HDM1002 radioactivity in urine and feces, following oral administration of [14C] HDM1002