Clinical trial NCT06723691: Influence of HRS9531 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin in Healthy Subjects
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-09
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Area under the acetaminophen plasma concentration-time curve
timeFrame: From time 0 to 24 hours after a single dose.
measure: Maximum observed acetaminophen concentration
timeFrame: From time 0 to 24 hours after a single dose.
measure: Time of maximum observed acetaminophen concentration
timeFrame: From time 0 to 24 hours after a single dose.
measure: Area under the metformin plasma concentration-time curve
timeFrame: From time 0 to 12 hours after the last of 7 repeated doses.
measure: Area under the S-warfarin plasma concentration-time curve
timeFrame: From time 0 to 168 hours after a single dose.
measure: Area under the atorvastatin plasma concentration-time curve
timeFrame: From time 0 to 72 hours after a single dose.
measure: Area under the digoxin plasma concentration-time curve
timeFrame: From time 0 to 120 hours after a single dose.
Secondary outcomes:
measure: Area under the concentration versus time curve of acetaminophen from 0 to infinity
timeFrame: Start of treatment up to 168 hours.
measure: Apparent volume of distribution of acetaminophen
timeFrame: Start of treatment up to 168 hours.
measure: Time of maximum observed metformin concentration after 3.5 days of treatment
timeFrame: Start of Treatment up to 30 hours.
measure: Clearance of metformin after 3.5 days of treatment
timeFrame: Start of Treatment up to 30 hours.
measure: Apparent volume of distribution of metformin after 3.5 days of treatment
timeFrame: Start of Treatment up to 30 hours.
measure: Time of maximum observed S-warfarin concentration
timeFrame: Start of Treatment up to 168 hours.
measure: Clearance of S-warfarin
timeFrame: Start of Treatment up to 168 hours.
measure: Apparent volume of distribution of S-warfarin
timeFrame: Start of Treatment up to 168 hours.
measure: Time of maximum observed atorvastatin (and its active metabolites) concentration
timeFrame: Start of Treatment up to 72 hours.
measure: Clearance of atorvastatin (and its active metabolites)
timeFrame: Start of Treatment up to 72 hours.
measure: Time of maximum observed digoxin concentration
timeFrame: Start of Treatment up to 120 hours.
measure: Maximum observed digoxin concentration
timeFrame: Start of Treatment up to 120 hours.
measure: Clearance of digoxin
timeFrame: Start of Treatment up to 120 hours.
measure: Apparent volume of distribution of digoxin
timeFrame: Start of Treatment up to 120 hours.
measure: Time of maximum observed HRS9532 concentration
timeFrame: Start of Treatment up to 168 hours.
measure: Maximum observed HRS9531 concentration
timeFrame: Start of Treatment up to 168 hours.
measure: Area under the concentration versus time curve of HRS9531 from 0 to the time of the last measurable (positive) concentration
timeFrame: Start of Treatment up to 168 hours.
measure: Area under the concentration versus time curve of HRS9531 from 0 to infinity
timeFrame: Start of Treatment up to 168 hours.
measure: Incidence and severity of adverse events
timeFrame: Screening period up to 117 days.
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Affiliated Hospital of Anhui Medical University
state: Anhui
Study officials:
References: