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NCT Number: NCT06576401

A 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.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;

Treatment and study plan

[14C] HDM1002

Drug

Administered orally

Primary outcomes

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

    Time frame: 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

  2. Metabolite profiling/identification in plasma, urine, and feces

    Time frame: 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.

  3. Plasma and whole blood AUC[0-t] of radioactivity

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

    PK parameter : Area under the curve from time 0 to t hour

  4. Plasma and whole blood AUC[0-∞] of radioactivity

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

    PK parameter : Area under the curve from time 0 hour to ∞

  5. Plasma and whole blood Cmax of radioactivity

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

    PK parameter : Maximum observed concentration

  6. Plasma and whole blood Tmax of radioactivity

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

    PK parameter : Time to maximum plasma concentration

  7. Plasma and whole blood t1/2 of radioactivity

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

    PK parameter: Half life

  8. Plasma and whole blood CL/F of radioactivity

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

    PK parameter : Apparent Clearance

  9. Plasma and whole blood Vz/F of radioactivity

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

    PK parameter : Apparent volume of distribution

  10. Percentage of plasma HDM1002 and metabolites in total plasma radioactivity

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

    Percentage of plasma HDM1002 AUC in total plasma radioactivity AUC

Secondary outcomes

  1. Plasma AUC[0-t] of HDM1002 and metabolites

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

    PK parameter : Area under the curve from time 0 to t hour

  2. Plasma AUC[0-∞] of HDM1002 and metabolites

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

    PK parameter : Area under the curve from time 0 hour to ∞

  3. Plasma Cmax of HDM1002 and metabolites

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

    PK parameter : Maximum observed concentration

  4. Plasma Tmax of HDM1002 and metabolites

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

    PK parameter : Time to maximum plasma concentration

  5. Plasma t1/2 of HDM1002 and metabolites

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

    PK parameter: Half life

  6. Plasma CL/F of HDM1002 and metabolites

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

    PK parameter : Apparent Clearance

  7. Plasma Vz/F of HDM1002 and metabolites

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

    PK parameter : Apparent volume of distribution

  8. Adverse events (AEs)

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

    Number of subjects reporting AEs

Study contacts

Contact information is provided by the study sponsor or research team.

Liyan Miao

CONTACT

[email protected]

0512-67972858

Sponsors and collaborators

Lead sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2024
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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