drugset / Trial / NCT03310463

Evaluation of the Pharmacokinetics, Safety, and Tolerability of Intravenous ETX2514 and Sulbactam Administered Concurrently to Subjects With Various Degrees of Renal Impairment and Healthy Matched Control Subjects

NCT03310463

Phase 1 Completed 34 enrolled Entasis Therapeutics
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This research project is being conducted to look at the pharmacokinetics (PK; how the human body processes a substance), safety, and tolerability of a single dose of ETX2514 and sulbactam (ETX2514SUL) when concurrently administered by separate intravenous (IV) infusion in participants with various degrees of renal impairment (RI), in participants with end-stage renal disease (ESRD) who are on hemodialysis (HD), and in healthy matched control participants with normal renal function.

Timeline

Start
2017-10-03
Primary completion
2018-05-25
Completion
2018-05-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Durlobactam Small molecule 1000 mg Intravenous
Subject Sulbactam Small molecule 1000 mg Intravenous