A Single-dose Study to Investigate the Pharmacokinetics of Intravenous FEP-TAZ 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).

Timeline

Start

2016-03

Primary completion

2016-08

Completion

2016-08

Publications

• Preston RA, Mamikonyan G, Mastim M, Garg D, Kemper CJ, Xu A, Yeole R, Chavan R, Friedland HD, Bhatia A. Single-Center Investigation of the Pharmacokinetics of WCK 4282 (Cefepime-Tazobactam Combination) in Renal Impairment. Antimicrob Agents Chemother. 2019 Sep 23;63(10):e00873-19. doi: 10.1128/AAC.00873-19. Print 2019 Oct.

Drugs

Indications