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

NCT06723691 | Completed Phase 1

• 1 other identifier: HRS9531-107
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• Area under the acetaminophen plasma concentration-time curve

  From time 0 to 24 hours after a single dose.

• Maximum observed acetaminophen concentration

  From time 0 to 24 hours after a single dose.

• Time of maximum observed acetaminophen concentration

  From time 0 to 24 hours after a single dose.

• Area under the metformin plasma concentration-time curve

  From time 0 to 12 hours after the last of 7 repeated doses.

• Area under the S-warfarin plasma concentration-time curve

  From time 0 to 168 hours after a single dose.

• Area under the atorvastatin plasma concentration-time curve

  From time 0 to 72 hours after a single dose.

• Area under the digoxin plasma concentration-time curve

  From time 0 to 120 hours after a single dose.

Secondary Outcomes (19)

• Area under the concentration versus time curve of acetaminophen from 0 to infinity

  Start of treatment up to 168 hours.

• Apparent volume of distribution of acetaminophen

  Start of treatment up to 168 hours.

• Time of maximum observed metformin concentration after 3.5 days of treatment

  Start of Treatment up to 30 hours.

• Clearance of metformin after 3.5 days of treatment

  Start of Treatment up to 30 hours.

• Apparent volume of distribution of metformin after 3.5 days of treatment

  Start of Treatment up to 30 hours.

Study Arms (1)

Treatment group

EXPERIMENTAL

Drug: Acetaminophen; Drug: Metformin; Drug: Warfarin; Drug: Atorvastatin; Drug: Digoxin; Drug: HRS9531

Interventions

Acetaminophen DRUG

Acetaminophen

Treatment group

Metformin DRUG

Metformin

Treatment group

Warfarin DRUG

Warfarin

Treatment group

Atorvastatin DRUG

Atorvastatin

Treatment group

Digoxin DRUG

Digoxin

Treatment group

HRS9531 DRUG

HRS9531

Treatment group

Eligibility Criteria

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

You may qualify if:

• Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
• Male subjects aged 18-45 years on the date of signing informed consent (inclusive);
• Body weight ≥60 kg, body mass index (BMI) within the range of 24.0-35.0 kg/m2 (inclusive);
• HbA1c\<6.0%;
• 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.

You may not qualify if:

• 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;
• Past history or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2), a history of pancreatitis or symptomatic gallbladder stones;
• History of disease that increases the risk of bleeding;
• Surgery within 6 months prior to dosing, planned to undergo surgery during the study period;
• Participation in clinical trials of any drug or medical device in the 3 months or 5 half-lives, whichever longer, prior to dosing;
• 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;
• Hepatitis B surface antigen (HBsAg), HIV antibody, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;
• Abnormal laboratory test results or abnormal examinations considered unsuitable to participate in this trial;
• History of hypoglycaemia;
• History of syncope or vasovagal episodes, difficulty with blood collection, or an inability to tolerate venipuncture;
• The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Acetaminophen; Metformin; Warfarin; Atorvastatin; Digoxin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Biguanides; Guanidines; Amidines; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Design

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

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 9, 2024
• Study Start: December 18, 2024
• Primary Completion: June 9, 2025
• Study Completion: June 9, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

CN (1)