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Completed

NCT Number: NCT06961643

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Henan Provincial Infectious Disease Hospital

Zhengzhou, Henan, 450015, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Aged 18-70 years old on the date of signing the ICF (including the threshold), both male and female.
  • 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

  • In the judgment of the investigator, may be allergic to the study drug or its components.
  • Smoking an average of more than 10 cigarettes per day within 3 months prior to screening.
  • 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.
  • History of drug or substance abuse, or a positive urine drug test at screening.
  • Donated or lost ≥ 400 mL of blood within 3 months prior to screening.
  • Individuals with a history of severe hypoglycemia.
  • Undergone surgery within 6 months prior to screening, or plan to undergo surgery during the trial period.

Treatment and study plan

HRS-7535 Tables

Drug

Oral HRS-7535 tables.

Primary outcomes

  1. The maximum plasma concentration of HRS-7535 (Cmax)

    Time frame: Post-dose at day 1 to day 4.

  2. Area under the concentration curve from time 0 to the last quantifiable concentration (AUC0-t)

    Time frame: Post-dose at day 1 to day 4.

  3. Area under the concentration curve from time 0 to extrapolated infinite time (AUC0-inf)

    Time frame: Post-dose at day 1 to day 4.

Secondary outcomes

  1. Time to maximum plasma concentration (Tmax)

    Time frame: Post-dose at day 1 to day 4.

  2. Terminal half-life (t1/2)

    Time frame: Post-dose at day 1 to day 4.

  3. Apparent clearance (CL/F)

    Time frame: Post-dose at day 1 to day 4.

  4. Apparent volume of distribution (Vz/F)

    Time frame: Post-dose at day 1 to day 4.

  5. Adverse events (AEs)

    Time frame: Screening period up to Day 7.

Sponsors and collaborators

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 8, 2025
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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