drugset / Trial / NCT03303924

Study to Determine and Compare Plasma and Intrapulmonary Concentrations of ETX2514 and Sulbactam in Healthy Subjects

NCT03303924

Phase 1 Completed 30 enrolled Entasis Therapeutics Clinartis · collab
NaSingle-groupOpen-labelBasic science

Summary

This is a Phase 1, multiple dose, open-label pharmacokinetic study conducted in healthy adult male and female subjects to determine and compare plasma, epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of ETX2514 and sulbactam in healthy adult subjects after intravenous infusion of ETX2514 1.0 g given concurrently with intravenous sulbactam 1.0 g, administered every 6 hours with each infused over 3 hours, for 3 consecutive doses

Timeline

Start
2017-08-21
Primary completion
2017-10-17
Completion
2017-10-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Durlobactam Small molecule 1 g Intravenous
Subject Sulbactam Small molecule 1 g Intravenous

Indications

No indication recorded.