Influence of HRS9531 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin in Healthy Subjects

NCT ID: NCT06723691

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-18
• Study Completion Date: 2025-06-09

Brief Summary

The purpose of this study is to evaluate the influence of HRS9531 injection on gastric emptying and pharmacokinetics of metformin, atorvastatin, warfarin, and digoxin in healthy subjects.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

Group Type: EXPERIMENTAL

Acetaminophen

Intervention Type: DRUG

Acetaminophen

Metformin

Intervention Type: DRUG

Metformin

Warfarin

Intervention Type: DRUG

Warfarin

Atorvastatin

Intervention Type: DRUG

Atorvastatin

Digoxin

Intervention Type: DRUG

Digoxin

HRS9531

Intervention Type: DRUG

HRS9531

Interventions

Acetaminophen

Acetaminophen

Intervention Type: DRUG

Metformin

Metformin

Intervention Type: DRUG

Warfarin

Warfarin

Intervention Type: DRUG

Atorvastatin

Atorvastatin

Intervention Type: DRUG

Digoxin

Digoxin

Intervention Type: DRUG

HRS9531

HRS9531

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;

2. Male subjects aged 18-45 years on the date of signing informed consent (inclusive);

3. Body weight ≥60 kg, body mass index (BMI) within the range of 24.0-35.0 kg/m2 (inclusive);

4. HbA1c<6.0%;

5. The subjects have no plans to have children and voluntarily take effective contraceptive measures from the time of signing the informed consent to 2 months after the last medication, and have no plans to donate eggs/sperm; the pregnancy test of female subjects with fertility must be negative.

Exclusion Criteria

1. Chronic or severe medical history of the respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system, etc., or those with existing systemic diseases mentioned above, and judged by the investigator to be unsuitable to participate in this study;

2. Past history or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2), a history of pancreatitis or symptomatic gallbladder stones;

3. History of disease that increases the risk of bleeding;

4. Surgery within 6 months prior to dosing, planned to undergo surgery during the study period;

5. Participation in clinical trials of any drug or medical device in the 3 months or 5 half-lives, whichever longer, prior to dosing;

6. Blood donation history or blood loss ≥400 mL within 3 months or ≥200 mL within 1 month before dosing, or received blood transfusion within 3 months before dosing;

7. Hepatitis B surface antigen (HBsAg), HIV antibody, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;

8. Abnormal laboratory test results or abnormal examinations considered unsuitable to participate in this trial;

9. History of hypoglycaemia;

10. History of syncope or vasovagal episodes, difficulty with blood collection, or an inability to tolerate venipuncture;

11. The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fujian Shengdi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Countries

China

Other Identifiers

HRS9531-107

Identifier Type: -

Identifier Source: org_study_id