To Investigate The Pharmacokinetics Of Intravenous WCK 5222 (FEP-ZID) In Patients With Renal Impairment

Summary

This is a Phase 1, open label, single-dose, pharmacokinetic study to be conducted in male and female subjects with normal and impaired renal function. The study will be composed of five groups of patients with mild (6 patients), moderate (6 patients), severe (6 patients) renal impairment, end stage renal disease patients on hemodialysis (6 patients) and their respective matched controls in 1:1 ratio (24 healthy subjects with normal renal function). The severity of renal impairment will be assessed based on estimated creatinine clearance (CLCR) by the Cockcroft-Gault equation

Timeline

Start

2016-10-25

Primary completion

2017-04

Completion

2017-04

Publications

• Preston RA, Mamikonyan G, DeGraff S, Chiou J, Kemper CJ, Xu A, Mastim M, Yeole R, Chavan R, Patel A, Friedland HD, Bhatia A. Single-Center Evaluation of the Pharmacokinetics of WCK 5222 (Cefepime-Zidebactam Combination) in Subjects with Renal Impairment. Antimicrob Agents Chemother. 2018 Dec 21;63(1):e01484-18. doi: 10.1128/AAC.01484-18. Print 2019 Jan.

Drugs

Indications