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Completed

NCT Number: NCT06723691

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Acetaminophen

Drug

Acetaminophen

metformin

Drug

Metformin

Warfarin

Drug

Warfarin

atorvastatin

Drug

Atorvastatin

Digoxin

Drug

Digoxin

HRS9531

Drug

HRS9531

Primary outcomes

  1. Area under the acetaminophen plasma concentration-time curve

    Time frame: From time 0 to 24 hours after a single dose.

  2. Maximum observed acetaminophen concentration

    Time frame: From time 0 to 24 hours after a single dose.

  3. Time of maximum observed acetaminophen concentration

    Time frame: From time 0 to 24 hours after a single dose.

  4. Area under the metformin plasma concentration-time curve

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

  5. Area under the S-warfarin plasma concentration-time curve

    Time frame: From time 0 to 168 hours after a single dose.

  6. Area under the atorvastatin plasma concentration-time curve

    Time frame: From time 0 to 72 hours after a single dose.

  7. Area under the digoxin plasma concentration-time curve

    Time frame: From time 0 to 120 hours after a single dose.

Secondary outcomes

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

    Time frame: Start of treatment up to 168 hours.

  2. Apparent volume of distribution of acetaminophen

    Time frame: Start of treatment up to 168 hours.

  3. Time of maximum observed metformin concentration after 3.5 days of treatment

    Time frame: Start of Treatment up to 30 hours.

  4. Clearance of metformin after 3.5 days of treatment

    Time frame: Start of Treatment up to 30 hours.

  5. Apparent volume of distribution of metformin after 3.5 days of treatment

    Time frame: Start of Treatment up to 30 hours.

  6. Time of maximum observed S-warfarin concentration

    Time frame: Start of Treatment up to 168 hours.

  7. Clearance of S-warfarin

    Time frame: Start of Treatment up to 168 hours.

  8. Apparent volume of distribution of S-warfarin

    Time frame: Start of Treatment up to 168 hours.

  9. Time of maximum observed atorvastatin (and its active metabolites) concentration

    Time frame: Start of Treatment up to 72 hours.

  10. Clearance of atorvastatin (and its active metabolites)

    Time frame: Start of Treatment up to 72 hours.

  11. Time of maximum observed digoxin concentration

    Time frame: Start of Treatment up to 120 hours.

  12. Maximum observed digoxin concentration

    Time frame: Start of Treatment up to 120 hours.

  13. Clearance of digoxin

    Time frame: Start of Treatment up to 120 hours.

  14. Apparent volume of distribution of digoxin

    Time frame: Start of Treatment up to 120 hours.

  15. Time of maximum observed HRS9532 concentration

    Time frame: Start of Treatment up to 168 hours.

  16. Maximum observed HRS9531 concentration

    Time frame: Start of Treatment up to 168 hours.

  17. Area under the concentration versus time curve of HRS9531 from 0 to the time of the last measurable (positive) concentration

    Time frame: Start of Treatment up to 168 hours.

  18. Area under the concentration versus time curve of HRS9531 from 0 to infinity

    Time frame: Start of Treatment up to 168 hours.

  19. Incidence and severity of adverse events

    Time frame: Screening period up to 117 days.

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Single Center, Open-label, Two Cohorts, Fixed Sequence Trial, Investigating the Influence of HRS9531 Injection on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin in Healthy Subjects

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2024
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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