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NCT Number: NCT06608329

A Relative Bioavailability and Food Effect Study of HDM1002 in Healthy Subjects

The main purpose of this study is to evaluate the effect of formulation on relative bioavailability of HDM1002, and the food effect on pharmacokinetics of HDM1002.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Location contact

Ying Wang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • According to the medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination results during the screening period, the investigator considers the subject to be in good general health.
  • Age range of 18-45 years old (including range), no limit to gender.
  • Male subject weighed ≥50.0 kg, female subject weighed ≥45.0 kg, and a body mass index (BMI) within the range of 19.0 - 30.0 kg/m2 (including cut-off values).
  • Female subject of childbearing potentiaafter last dose, who have no childbearing plans and agrl during signature ICF to 30 days after last dose and male subject during signature ICF to 90 days ee to use highly effective contraception and consent not to donate sperm and oocyte during this period.

Exclusion criteria

  • Subject has a history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin≥50 ng/L during the screening period.
  • History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
  • History of acute cholecystitis attack within 3 months prior to screening.
  • Subject judged by investigator has dysphagia, diseases or conditions that affect gastric emptying, or affect the absorption of gastrointestinal nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.
  • History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period.
  • During screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant .
  • Taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug.
  • History of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission.
  • Presence of clinically significant ECG results judged by the investigator at screening.

Treatment and study plan

HDM1002

Drug

Single dose, administered orally. The study is a randomized, open-label, single dose, 3-period, 3 sequence, crossover design.

Primary outcomes

  1. AUC[0-∞]

    Time frame: Day1-Day17

    Area under the curve from time 0 hour to ∞

  2. AUC[0-t]

    Time frame: Day1-Day17

    Area under the curve from time 0 to t hour

  3. Cmax

    Time frame: Day1-Day17

    Maximum observed concentration

  4. Tmax

    Time frame: Day1-Day17

    Time to maximum plasma concentration

  5. t1/2

    Time frame: Day1-Day17

    Half life

  6. CL/F

    Time frame: Day1-Day17

    Apparent Clearance

  7. Vz/F

    Time frame: Day1-Day17

    Apparent volume of distribution

  8. F

    Time frame: Day1-Day17

    Relative Bioavailability

Secondary outcomes

  1. Adverse events (AEs)

    Time frame: Day1-Day17

    Number of subjects reporting AEs

Study contacts

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

Sponsors and collaborators

Lead sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Open-label, Crossover Study to Evaluate Relative Bioavailability, and Food Effect of HDM1002 in Healthy Subjects

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 23, 2024
Registry last updated
Sep 23, 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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