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

Phase 1

Recruiting

• Conditions: Hypertrophic Cardiomyopathy
• Interventions: Drug: HRS-1893

• Registration Number: NCT06775834
• Lead Sponsor: Shandong Suncadia Medicine Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Study Start: 2025-02-11
• Status Verified: 2025-03
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Sign the informed consent before the trial, and fully understand the content, process and possible adverse reactions of the trial;
2. Male or female subjects aged 18 to 65 (including 18 and 65);
3. Body mass index (BMI) ranges from 19 kg/m2 to 28 kg/m2 (including 18 and 28);
4. 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

1. Suspected allergy to the study drug or any component of the study drug;
2. 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;
3. People with conditions associated with reduced neuromuscular transmission (myasthenia gravis, Lambert-Eaton syndrome, Duchenne muscular dystrophy);
4. Patients with a history of gastric or intestinal surgery that may affect drug absorption;
5. Participants with renal insufficiency who were judged by the investigator to be ineligible for the study;
6. Patients with large fluctuations or rapid deterioration of renal function within 2 weeks before administration, as judged by the investigator;
7. Subjects receiving renal replacement therapy within 3 months of the screening period or during the expected trial period;
8. Within 3 months before screening, patients with underlying diseases that induced chronic kidney disease and were poorly controlled according to the investigator's evaluation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild Renal Impairment Group	HRS-1893	-
Normal Renal Function Group	HRS-1893	-
Moderate Renal Impairment Group	HRS-1893	-

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax)	0 hour to 16 days after the dosing.
Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration (AUC0-t)	0 hour to 16 days after the dosing.
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)	0 hour to 16 days after the dosing.

Secondary Outcome Measures

Name	Time	Method
Apparent clearance (CL/F)	0 hour to 16 days after the dosing.
Cumulative excretion (Ae)	0 hour to 16 days after the dosing.
Apparent volume of distribution (Vz/F)	0 hour to 16 days after the dosing.
Plasma protein binding rate (PPB)	0 hour to 16 days after the dosing.
Time to reach maximum plasma concentration (Tmax)	0 hour to 16 days after the dosing.
Terminal half-life (t1/2)	0 hour to 16 days after the dosing.
Incidence and severity of adverse events (AEs)	0 hour to 16 days after the dosing.

Trial Locations

Locations (1)

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China