NCT05497297

A Study to Evaluate the Pharmacokinetics of HSK7653 in Subjects With Renal Impairment

An Open-label, Single-dose Study to Assess the Pharmacokinetics of HSK7653 Tablets in Subjects With Varying Degrees of Renal Impairment Compared to the Control Subjects With Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, single-dose study to evaluate the pharmacokinetics, pharmacodynamics and safety of HSK7653 in subjects with mild, moderate, severe renal impairment and subjects with kidney failure compared to the matched control subjects with normal renal function.

Detailed description

This is an open-label, single-dose Phase I study that evaluate the pharmacokinetics, pharmacodynamics and safety of a single dose of HSK7653 10 mg in subjects with mild, moderate, and severe renal impairment , subjects with kidney failure and the control subjects with normal renal function. This study consists of a screening period (Day -14 to Day -1), a baseline period (Day -1), a treatment period (Day 1 to Day 29), and a follow-up call on Day 32. Subjects will be enrolled in the following groups: Glomerular filtration rate (GFR, unit mL/min/1.73m\^2) will be calculated based on Modification of Diet in Renal Disease (MDRD) equation at screening, Multiply it by BSA, then divide by 1.73 to convert to absolute GFR (unit, mL/min) (group A1) mild renal impairment (60 ≤ GFR\< 90 mL/min); (group B1) moderate renal impairment (30 ≤ GFR\<60 mL/min); (group C1) severe renal impairment (15 ≤ GFR\< 30 mL/min); (group D1) kidney failure (\<15 mL/min, not on hemodialysis); (group A2,B2,C2,D2) control subjects with normal renal function will be matched with subjects with renal impairment by weight, age, and sex (GFR≥90 mL/min).If subjects in group A2 can be matched with the subjects in groups A1 and B1 at the same time, the subjects in group B2 will not be enrolled, and so on. Approximately 64 subjects will be enrolled in total.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	HSK7653 tablets	HSK7653, tablet, oral

Timeline

• Start date: 2022-08-04
• Primary completion: 2022-10-23
• Completion: 2022-10-26
• First posted: 2022-08-11
• Last updated: 2023-01-03

Locations

1 site across 1 country: China