NCT04859439

A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Renal Impairment

An Open-label, Single-dose, Phase I Clinical Study to Assess the Pharmacokinetics and Safety of DBPR108 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: 40 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology 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 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.

Detailed 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.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	DBPR108 tablets	Drug: DBPR108, tablet, oral

Timeline

• Start date: 2021-06-15
• Primary completion: 2021-11-30
• Completion: 2021-12-31
• First posted: 2021-04-26
• Last updated: 2022-05-10

Locations

1 site across 1 country: China