Investigation of Pharmacokinetics and Safety of HRS-7535 in Subjects With Hepatic Impairment and Normal Hepatic Function

Shandong Suncadia Medicine

Status and phase: Not yet enrolling; Phase 1

Conditions: Diabetes Mellitus

Treatments: Drug: HRS-7535 Tables

Study type: Interventional

Funder types: Industry

Identifiers

NCT06961643

HRS-7535-109

Details and patient eligibility

About

The study is being conducted to compare the pharmacokinetics and safety of HRS-7535 in subjects with mild to moderate hepatic impairment and normal hepatic function.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Ability to understand the study procedures and methods, participate voluntarily and be able to complete the study according to the protocol requirements, and sign the informed consent form (ICF) in writing.
2. Aged 18-70 years old on the date of signing the ICF (including the threshold), both male and female.
3. At the time of screening, male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg; body mass index (BMI): 18~32 kg/m2 (including the threshold).

Exclusion criteria

1. In the judgment of the investigator, may be allergic to the study drug or its components.
2. Smoking an average of more than 10 cigarettes per day within 3 months prior to screening.
3. Alcoholics of within 3 months prior to screening, who consume more than 14 units of alcohol per week (1 unit=beer)360 mL of alcohol, or 45 mL of strong liquor with an alcohol content of 40%, or 150 mL of wine.
4. History of drug or substance abuse, or a positive urine drug test at screening.
5. Donated or lost ≥ 400 mL of blood within 3 months prior to screening.
6. Individuals with a history of severe hypoglycemia.
7. Undergone surgery within 6 months prior to screening, or plan to undergo surgery during the trial period.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Treatment group A

Experimental group

Description:

Subjects with mild hepatic impairment.

Treatment:

Drug: HRS-7535 Tables

Treatment group B

Experimental group

Description:

Subjects with moderate hepatic impairment.

Treatment:

Drug: HRS-7535 Tables

Treatment group C

Experimental group

Description:

Subjects with normal hepatic function.

Treatment:

Drug: HRS-7535 Tables