Hypertrophic Cardiomyopathy
Conditions
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.
Interventions
DRUGHRS-1893
HRS-1893 tablets.
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Apparent volume of distribution (Vz/F) | 0 hour to 16 days after the dosing. |
| Cumulative excretion (Ae) | 0 hour to 16 days after the dosing. |
| Time to reach maximum plasma concentration (Tmax) | 0 hour to 16 days after the dosing. |
| Incidence and severity of adverse events (AEs) | 0 hour to 16 days after the dosing. |
| Plasma protein binding rate (PPB) | 0 hour to 16 days after the dosing. |
| Terminal half-life (t1/2) | 0 hour to 16 days after the dosing. |
| Apparent clearance (CL/F) | 0 hour to 16 days after the dosing. |
Countries
China
Outcome results
None listed