Pharmacokinetic and Safety Studies of HRS-7535 in Subjects With Moderate Renal Insufficiency and Healthy Subjects

NCT06132204 | Completed Phase 1

• 1 other identifier: HRS-7535-102
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate and compare the pharmacokinetics of HRS-7535 tablets in subjects with moderate renal insufficiency and healthy subjects.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

• PK parameters of HRS-7535: Cmax

  0 hour to 48 hour after administration

• PK parameters of HRS-7535: AUC0-t

  0 hour to 48 hour after administration

• PK parameters of HRS-7535: AUC0-inf

  0 hour to Infinity hour after administration

Secondary Outcomes (5)

• PK parameters of HRS-7535: Tmax

  0 hour to 48 hour after administration

• PK parameters of HRS-7535: t1/2

  0 hour to 48 hour after administration

• PK parameters of HRS-7535: CL/F

  0 hour to 48 hour after administration

• PK parameters of HRS-7535: Vz/F

  0 hour to 48 hour after administration

• Adverse events

  from ICF signing date to day 7 （+3）after administration

Study Arms (2)

HRS-7535 Tablets-Moderately renal insufficiency subjects

EXPERIMENTAL

Drug: HRS-7535 Tablets

HRS-7535 Tablets-Healthy subjects

EXPERIMENTAL

Drug: HRS-7535 Tablets

Interventions

HRS-7535 Tablets DRUG

HRS-7535 Tablets

HRS-7535 Tablets-Healthy subjects; HRS-7535 Tablets-Moderately renal insufficiency subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range from 18 to 65 years old (including both ends, subject to signing the informed consent form), both male and female;
• The subject's body weight is ≥ 50 kg, and the body mass index (BMI) is within the range of 19.0\~32.0 kg/m2 (including both ends);
• From the signing of the informed consent form until 6 months after the last administration, the subject (including partner) has no family planning and is willing to use the high-efficiency contraceptive measures specified in the plan;
• Before the experiment, voluntarily sign an informed consent form and have a thorough understanding of the experiment content, process, and potential adverse reactions.
• For Moderately renal insufficiency subjects， 30 mL/min ≤ GFR\<60, and the renal function status is stable. Did not use drugs for treating renal insufficiency or was determined by the researcher to be stable in taking drugs for treating renal insufficiency for more than 4 weeks.
• For Healthy subjects，90 mL/min \< GFR；there was no history of chronic kidney disease during screening. Weight, age, and gender should meet the matching requirements for subjects with moderate renal insufficiency.

You may not qualify if:

• During screening period, glutamate alanine aminotransferase (AST) ≥ 2 × Upper limit of normal range (ULN); Glutamate aspartate aminotransferase (ALT) ≥ 2 × ULN; Total bilirubin (TBIL) ≥ 1.5 × ULN;
• Abnormal and clinically significant 12 lead electrocardiogram (ECG), or ECG QTcF\>450 ms (corrected according to Fridericia's formula);
• Hepatitis B surface antigen is positive, hepatitis C antibody is positive, Treponema pallidum antibody is positive, HIV antibody is positive;
• Have a history of life-threatening diseases within 5 years (excluding basal cell skin cancer or squamous cell skin cancer);
• Previous history of medullary thyroid cancer, multiple endocrine neoplasia type 2 or family history, previous history of pancreatitis or symptomatic gallbladder disease;
• Previous clinical history of gastric emptying abnormalities (such as gastric outlet obstruction), severe chronic gastrointestinal diseases (such as inflammatory bowel disease and active ulcers);
• Other clinically significant diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, tumor, lung, immune, psychiatric, or cardiovascular diseases) found within the first 6 months of screening;
• Have undergone gastrointestinal surgery that can cause malabsorption before screening, or have taken drugs that have a direct impact on gastrointestinal peristalsis for a long time;
• Have used drugs that may affect glucose metabolism within the first month of screening (such as systemic steroids and non-selective drugs) β Receptor blockers, monoamine oxidase inhibitors);
• Have used glucagon like peptide peptide-1 receptor agonists within the first 3 months of screening;
• Individuals with severe allergic diseases or known or suspected allergies or allergies to any component of the study drug (including multiple drug and food allergies);
• Discontinuation of glucagon like peptide-1 receptor agonist therapy due to safety/tolerance reasons or lack of efficacy in the past;
• Have received clinical trial treatment of any drug or medical device within the first 3 months or 5 half-lives (whichever is longer) before screening, or plan to participate in clinical trials of other drugs or medical devices during the trial period;
• Screening for individuals who have consumed more than 14 units of alcohol per week within the first 6 months or who have taken alcoholic products 48 hours before administration; Or positive for alcohol breath test;
• Smoking more than 5 cigarettes per day within the first 3 months of screening or using any tobacco products 48 hours before administration;

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 15, 2023
• Study Start: December 21, 2023
• Primary Completion: March 13, 2024
• Study Completion: March 13, 2024
• Last Updated: October 15, 2024

Record last verified: 2023-11

Locations

CN (1)