Safety and Pharmacokinetics Study of HRS-1893 Tablets in Healthy Subjects and Those With Impaired… (NCT06775834) | Clinical Trial Compass
CompletedPhase 1
Safety and Pharmacokinetics Study of HRS-1893 Tablets in Healthy Subjects and Those With Impaired Kidney Function
China24 participantsStarted 2025-02-11
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Sign the informed consent before the trial, and fully understand the content, process and possible adverse reactions of the trial;
✓. Male or female subjects aged 18 to 65 (including 18 and 65);
✓. Body mass index (BMI) ranges from 19 kg/m2 to 28 kg/m2 (including 18 and 28);
✓. 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
✕. Suspected allergy to the study drug or any component of the study drug;
✕. 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;
✕. People with conditions associated with reduced neuromuscular transmission (myasthenia gravis, Lambert-Eaton syndrome, Duchenne muscular dystrophy);
✕. Patients with a history of gastric or intestinal surgery that may affect drug absorption;
✕. Participants with renal insufficiency who were judged by the investigator to be ineligible for the study;
✕. Patients with large fluctuations or rapid deterioration of renal function within 2 weeks before administration, as judged by the investigator;
What they're measuring
1
Maximum plasma concentration (Cmax)
Timeframe: 0 hour to 16 days after the dosing.
2
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.
3
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
. Subjects receiving renal replacement therapy within 3 months of the screening period or during the expected trial period;
✕. Within 3 months before screening, patients with underlying diseases that induced chronic kidney disease and were poorly controlled according to the investigator's evaluation.