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Completed

NCT Number: NCT06775834

Safety and Pharmacokinetics Study of HRS-1893 Tablets in Healthy Subjects and Those With Impaired Kidney Function

The primary objective is to evaluate pharmacokinetics of HRS-1893 tablets in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Sign the informed consent before the trial, and fully understand the content, process and possible adverse reactions of the trial;
  • Male or female subjects aged 18 to 65 (including 18 and 65);
  • Body mass index (BMI) ranges from 19 kg/m2 to 28 kg/m2 (including 18 and 28);
  • The glomerular filtration rate should meet the following criteria (GFR, mL/min): Subjects with mild renal impairment: 60-89 mL/min; Subjects with moderate renal impairment: 30-59 mL/min.

Exclusion criteria

  • Suspected allergy to the study drug or any component of the study drug;
  • Patients with cardiogenic shock, severe conduction block, sick sinus syndrome, heart failure, sustained tachyarrhythmia, torsades de pointes (Tdp) or ventricular tachycardia, history of clinically significant T wave changes, myocardial infarction, angina pectoris;
  • People with conditions associated with reduced neuromuscular transmission (myasthenia gravis, Lambert-Eaton syndrome, Duchenne muscular dystrophy);
  • Patients with a history of gastric or intestinal surgery that may affect drug absorption;
  • Participants with renal insufficiency who were judged by the investigator to be ineligible for the study;
  • Patients with large fluctuations or rapid deterioration of renal function within 2 weeks before administration, as judged by the investigator;
  • Subjects receiving renal replacement therapy within 3 months of the screening period or during the expected trial period;
  • Within 3 months before screening, patients with underlying diseases that induced chronic kidney disease and were poorly controlled according to the investigator's evaluation.

Treatment and study plan

HRS-1893

Drug

HRS-1893 tablets.

Primary outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: 0 hour to 16 days after the dosing.

  2. Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration (AUC0-t)

    Time frame: 0 hour to 16 days after the dosing.

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)

    Time frame: 0 hour to 16 days after the dosing.

Secondary outcomes

  1. Time to reach maximum plasma concentration (Tmax)

    Time frame: 0 hour to 16 days after the dosing.

  2. Terminal half-life (t1/2)

    Time frame: 0 hour to 16 days after the dosing.

  3. Apparent clearance (CL/F)

    Time frame: 0 hour to 16 days after the dosing.

  4. Apparent volume of distribution (Vz/F)

    Time frame: 0 hour to 16 days after the dosing.

  5. Cumulative excretion (Ae)

    Time frame: 0 hour to 16 days after the dosing.

  6. Plasma protein binding rate (PPB)

    Time frame: 0 hour to 16 days after the dosing.

  7. Incidence and severity of adverse events (AEs)

    Time frame: 0 hour to 16 days after the dosing.

Sponsors and collaborators

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

Safety and Pharmacokinetic Study of HRS-1893 Tablets in Subjects With Mild and Moderate Renal Insufficiency and Healthy Subjects

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2025
Registry last updated
Sep 10, 2025

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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