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

NCT06608329 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: HDM1002-108
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Adult Subject

Keywords

HDM1002 tablet; Glucagon-Like Peptide-1 Receptor Agonists

Outcome Measures

Primary Outcomes (8)

• AUC[0-∞]

  Area under the curve from time 0 hour to ∞

  Day1-Day17

• AUC[0-t]

  Area under the curve from time 0 to t hour

  Day1-Day17

• Cmax

  Maximum observed concentration

  Day1-Day17

• Tmax

  Time to maximum plasma concentration

  Day1-Day17

• t1/2

  Half life

  Day1-Day17

• CL/F

  Apparent Clearance

  Day1-Day17

• Vz/F

  Apparent volume of distribution

  Day1-Day17

• F

  Relative Bioavailability

  Day1-Day17

Secondary Outcomes (1)

• Adverse events (AEs)

  Day1-Day17

Study Arms (3)

Cohort 1

EXPERIMENTAL

Period 1: Subjects received HDM1002 table (200 mg×1）in fasted state; Period 2: Subjects received HDM1002 tables (100 mg×2）in fasted state; Period 3: Subjects received HDM1002 table (200 mg×1）in fed state.

Drug: HDM1002

Cohort 2

EXPERIMENTAL

Period 1: Subjects received HDM1002 tables (100 mg×2）in fasted state; Period 2: Subjects received HDM1002 table (200 mg×1）in fed state; Period 3: Subjects received HDM1002 table (200 mg×1）in fasted state.

Drug: HDM1002

Cohort 3

EXPERIMENTAL

Period 1: Subjects received HDM1002 table (200 mg×1）in fed state; Period 2: Subjects received HDM1002 table (200 mg×1）in fasted state; Period 3: Subjects received HDM1002 tables (100 mg×2）in fasted state.

Drug: HDM1002

Interventions

HDM1002 DRUG

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

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Location

Central Study Contacts

Ying Wang

CONTACT

+86-18367124548; nancywangying@163.com

Study Design

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

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: October 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

CN (1)