A multi-center, open-label, two-part study to investigate the effect of renal function and hemodialysis on the pharmacokinetics of the novel β-lactamase inhibitor nacubactam

was 2-fold, 3.7-fold, and 6.6-fold higher in the mild, moderate, and severe impairment groups, respectively. Similar results were observed across four different methods of estimating renal clearance. Nacubactam was cleared by hemodialysis, with more than 60% of a single dose eliminated during a 4-h dialysis session. Renal impairment had no apparent effect on the safety profile of nacubactam, and a single 1 g dose was well tolerated in all groups. These data can be used to underwrite nacubactam dosing recommendations for patients with impaired renal function, including those receiving renal replacement therapy.CLINICAL TRIALSThis study is registered with ClinicalTrials.gov as NCT02975388.