Evaluating HRS-1893 Tablets in Healthy and Kidney-Impaired Individuals

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

This study is testing how well HRS-1893 tablets work in healthy people compared to those with kidney problems to help figure out the right dosage for everyone.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Shandong Suncadia Medicine Co., Ltd. (industry)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06775834 on ClinicalTrials.gov

What this trial studies

This study aims to assess the pharmacokinetics of HRS-1893 tablets in healthy subjects compared to those with impaired kidney function. It focuses on understanding how renal impairment affects the drug's absorption, distribution, metabolism, and excretion. The findings will help establish appropriate dosing recommendations for patients with varying degrees of kidney function. The study is interventional and is classified as Phase 1, indicating it is in the early stages of testing.

Who should consider this trial

Good fit: Ideal candidates include healthy individuals and those aged 18 to 65 with mild to moderate renal impairment.

Not a fit: Patients with severe heart conditions or significant neuromuscular transmission disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer and more effective dosing guidelines for patients with kidney impairment who require treatment for hypertrophic cardiomyopathy.

How similar studies have performed: While this study focuses on a specific drug and population, similar pharmacokinetic studies have shown promise in optimizing treatment for patients with renal impairment.

Eligibility criteria

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.

Where this trial is running

Chengdu, Sichuan

• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (RECRUITING)

Study contacts

• Study coordinator: Hongda Lin, M.M

Conditions: Hypertrophic Cardiomyopathy