Clinical trial NCT06775834: Safety and Pharmacokinetics Study of HRS-1893 Tablets in Healthy Subjects and Those With Impaired Kidney Function
Official title: Safety and Pharmacokinetic Study of HRS-1893 Tablets in Subjects With Mild and Moderate Renal Insufficiency and Healthy Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hypertrophic Cardiomyopathy
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: 0 hour to 16 days after the dosing.
measure: Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration (AUC0-t)
timeFrame: 0 hour to 16 days after the dosing.
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
timeFrame: 0 hour to 16 days after the dosing.
Secondary outcomes:
measure: Time to reach maximum plasma concentration (Tmax)
timeFrame: 0 hour to 16 days after the dosing.
measure: Terminal half-life (t1/2)
timeFrame: 0 hour to 16 days after the dosing.
measure: Apparent clearance (CL/F)
timeFrame: 0 hour to 16 days after the dosing.
measure: Apparent volume of distribution (Vz/F)
timeFrame: 0 hour to 16 days after the dosing.
measure: Cumulative excretion (Ae)
timeFrame: 0 hour to 16 days after the dosing.
measure: Plasma protein binding rate (PPB)
timeFrame: 0 hour to 16 days after the dosing.
measure: Incidence and severity of adverse events (AEs)
timeFrame: 0 hour to 16 days after the dosing.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
References: