Influence of HRS9531 on Pharmacokinetics of Metformin in Healthy Subjects

NCT06654960 | Completed Phase 1

• 1 other identifier: HRS9531-106
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the influence of HRS9531 injection on pharmacokinetics of metformin in healthy subjects.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Area under the concentration versus time curve (AUC) of metformin from dosing time (0) to tau (dosing interval) (AUCtau) after 3.5 days.

  Start of treatment up to 12 hours.

Secondary Outcomes (15)

• Time to maximum concentration (Tmax) of metformin after 3.5 days of treatment.

  Start of Treatment up to 30 hours.

• Maximum concentration (Cmax) of metformin after 3.5 days of treatment.

  Start of Treatment up to 30 hours.

• Area under the concentration versus time curve of metformin from 0 to the time of the last measurable (positive) concentration (AUC0-t) after 3.5 days of treatment.

  Start of Treatment up to 30 hours.

• Area under the concentration versus time curve of metformin from 0 to infinity (AUC0-inf) after 3.5 days of treatment.

  Start of Treatment up to 30 hours.

• Terminal half-life (t1/2) of metformin after 3.5 days of treatment.

  Start of Treatment up to 30 hours.

Study Arms (1)

Single arm

EXPERIMENTAL

Drug: HRS9531 injection; Drug: Metformin Hydrochloride tablets

Interventions

HRS9531 injection DRUG

HRS9531 injection single dose.

Single arm

Metformin Hydrochloride tablets DRUG

Metformin Hydrochloride tablets 500mg.

Single arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• 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 ≥50 kg, body mass index (BMI) within the range of 20.0-30.0 kg/m2 (inclusive);
• HbA1c\<6.0%.

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;
• Obvious gastric emptying abnormalities or gastrointestinal diseases in the past, or had undergone gastrointestinal surgery (except for gastrointestinal polyps, appendix, and haemorrhoidectomy)
• Past history or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2), a history of pancreatitis or symptomatic gallbladder stones;
• 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;
• Allergic constitution includes severe drug allergy or history of drug allergy;
• 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;
• 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

Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

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: October 21, 2024
• First Posted: October 23, 2024
• Study Start: November 5, 2024
• Primary Completion: December 26, 2024
• Study Completion: December 26, 2024
• Last Updated: January 7, 2025

Record last verified: 2024-10

Locations

CN (1)