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Clinical Trial Summary

This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of DBPR108 in subjects with mild, moderate, severe renal impairment and subjects with kidney failure compared to the matched control subjects with normal renal function.


Clinical Trial Description

This is an open-label, single-dose Phase I study that evaluate the pharmacokinetics, safety, and tolerability of a single dose of DBPR108 100 mg in subjects with mild, moderate, and severe renal impairment (RI), 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 3), and a follow-up call on Day 6. Subjects will be enrolled in the following groups: Estimated glomerular filtration rate (eGFR) will be calculated based on Modification of Diet in Renal Disease (MDRD) equation at screening. (A) mild renal impairment (60 ≤ eGFR≤ 89 mL/min/1.73m2); (B) moderate renal impairment (30 ≤ eGFR≤ 59 mL/min/1.73m2); (C) severe renal impairment (15 ≤ eGFR≤ 29 mL/min/1.73m2); (D) kidney failure (<15 mL/min/1.73m2, not on hemodialysis); (E) control subjects with normal renal function will be matched with subjects with HI by weight, age, and sex (eGFR≥90 mL/min/1.73m2). Approximately 8 subjects will be enrolled in each group. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04859439
Study type Interventional
Source CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Contact Liyan Miao, Professor
Phone 0512-67972858
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date May 2021
Completion date March 2022

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