Not yet recruiting NCT06608329
A Relative Bioavailability and Food Effect Study of HDM1002 in Healthy Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HDM1002.
- Who it may be relevant to
- Registry conditions: Healthy Adult Subject. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Open-label, Crossover Study to Evaluate Relative Bioavailability, and Food Effect of HDM1002 in Healthy Subjects
Overview
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.
Interventions
- Drug HDM1002
Single dose, administered orally. The study is a randomized, open-label, single dose, 3-period, 3 sequence, crossover design.
Primary outcome measures
- AUC[0-∞] [Time frame: Day1-Day17]
- AUC[0-t] [Time frame: Day1-Day17]
- Cmax [Time frame: Day1-Day17]
- Tmax [Time frame: Day1-Day17]
- t1/2 [Time frame: Day1-Day17]
- CL/F [Time frame: Day1-Day17]
- Vz/F [Time frame: Day1-Day17]
- F [Time frame: Day1-Day17]
Secondary outcome measures (1)
- Adverse events (AEs) [Time frame: Day1-Day17]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Hangzhou First People's Hospital — Hangzhou
Identifiers
NCT: NCT06608329 · HDM1002-108