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

A Randomized, Open-label, Crossover Study to Evaluate Relative Bioavailability, and Food Effect 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Adult Subject
• Intervention / Treatment: Drug: HDM1002

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ying Wang; Phone Number: +86-18367124548; Email: nancywangying@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Hangzhou First People's Hospital
      • Principal Investigator: Ying Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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.
2. Age range of 18-45 years old (including range), no limit to gender.
3. 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).
4. 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:

1. 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.
2. History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
3. History of acute cholecystitis attack within 3 months prior to screening.
4. 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.
5. History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period.
6. During screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant .
7. Taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug.
8. History of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission.
9. Presence of clinically significant ECG results judged by the investigator at screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; 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; Single dose, administered orally. The study is a randomized, open-label, single dose, 3-period, 3 sequence, crossover design.
Experimental: Cohort 2; 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; Single dose, administered orally. The study is a randomized, open-label, single dose, 3-period, 3 sequence, crossover design.
Experimental: Cohort 3; 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; Single dose, administered orally. The study is a randomized, open-label, single dose, 3-period, 3 sequence, crossover design.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AEs)	Number of subjects reporting AEs	Day1-Day17

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 20, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Glucagon-Like Peptide-1 Receptor Agonists; HDM1002 tablet
• Other Study ID Numbers: HDM1002-108

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No