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

Fujian Shengdi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06723691

HRS9531-107

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

Treatment group

Experimental group

Treatment:

Drug: Warfarin

Drug: Acetaminophen

Drug: Atorvastatin

Drug: HRS9531

Drug: Digoxin

Drug: Metformin