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Clinical Trial Details

Trial ID: L0256
Source ID: NCT06039254
Associated Drug: Hrs-1780
Title: Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Disease
Interventions: DRUG: HRS-1780
Outcome Measures: Primary: Pharmacokinetics-Cmax, Maximum observed concentration of HRS-1780, Start of Treatment to end of study (approximately 1 week)|Pharmacokinetics-AUC0-last, Area under the concentration-time curve from time 0 to last time point after HRS-1780 administration, Start of Treatment to end of study (approximately 1 week)|Pharmacokinetics-AUC0-inf, Area under the concentration-time curve from time 0 to infinity after HRS-1780 administration, Start of Treatment to end of study (approximately 1 week) | Secondary: Pharmacokinetics-Tmax, Time to Cmax of HRS-1780, Start of Treatment to end of study (approximately 1 week)|Pharmacokinetics-t1/2, Terminal elimination half-life of HRS-1780, Start of Treatment to end of study (approximately 1 week)|Pharmacokinetics-CL/F, Apparent clearance of HRS-1780, Start of Treatment to end of study (approximately 1 week)|Pharmacokinetics-Vz/F, Apparent volume of distribution during terminal phase of HRS-1780, Start of Treatment to end of study (approximately 1 week)|Pharmacokinetics-Cumulative excretion (Ae), Cumulative amount of HRS-1780 excreted in urine, Start of Treatment to end of study (approximately 1 week)|Pharmacokinetics-Cumulative excretion rate (Ae%), Cumulative percentage of HRS-1780 recovered in urine, Start of Treatment to end of study (approximately 1 week)|Pharmacokinetics-Renal clearance (CLr), Clearance of HRS-1780 by kidney, Start of Treatment to end of study (approximately 1 week)|Binding rates of plasma protein (BRPP) of HRS-1780, Binding rates of plasma protein, Start of Treatment to end of study (approximately 1 week)|Adverse events, Incidence and severity of adverse events, Start of Treatment to end of study (approximately 1 week)
Sponsor/Collaborators: Sponsor: Shandong Suncadia Medicine Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 27
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-09
Completion Date: 2023-12-08
Results First Posted:
Last Update Posted: 2023-09-15
Locations:
URL: https://clinicaltrials.gov/show/NCT06039254