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

Launched by SHANDONG SUNCADIA MEDICINE CO., LTD. · Jan 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called HRS-1893, which comes in tablet form, to understand how it works in people with different levels of kidney function. The main goal is to see how the drug is processed in the body of healthy individuals compared to those who have mild to moderate kidney impairment. This information will help determine the best dosage for patients with kidney issues, particularly those with a condition known as hypertrophic cardiomyopathy, where the heart muscle becomes abnormally thick.

To participate in this trial, individuals need to be between 18 and 65 years old and have a body mass index (BMI) between 19 and 28. They should also have mild to moderate kidney function as measured by a specific test. However, certain people cannot participate, including those with serious heart problems or allergies to the study medication. Participants will be closely monitored throughout the study, and they will need to provide informed consent, which means they fully understand the study and any risks involved. This trial is currently recruiting, and it offers a chance to contribute to important research that could improve treatment for people with kidney and heart conditions.

Gender

ALL

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.