A Study to Investigate the Effect of Renal Function and Hemodialysis on the Pharmacokinetics (PK) of RO7079901

Summary

This is a multi-center, non-randomized, open-label, two-part study to investigate the effect of renal function and hemodialysis on PK of RO7079901. Part 1 will be conducted in adult male and female participants with stable mild, moderate or severe renal impairment and a control group of participants with normal renal function. Part 2 will be conducted in adult male and female participants with stable end-stage renal disease undergoing hemodialysis.

Timeline

Start

2016-12-20

Primary completion

2017-07-06

Completion

2017-07-06

Publications

• Morita J, Ishiwata K, Matsumoto S, Rodriguez I, Patel K, Attley G, Mallalieu NL, Bentley D. A multi-center, open-label, two-part study to investigate the effect of renal function and hemodialysis on the pharmacokinetics of the novel beta-lactamase inhibitor nacubactam. Antimicrob Agents Chemother. 2026 Jun 3;70(6):e0011326. doi: 10.1128/aac.00113-26. Epub 2026 Apr 30.

Drugs

Indications