drugset / Trial / NCT02971423

Evaluation of the Safety, Tolerability and Pharmacokinetics of Intravenous ETX2514 Administered in Healthy Subjects

NCT02971423

Phase 1 Completed 124 enrolled Entasis Therapeutics
RandomizedParallel-groupTriple-blindTreatment

Summary

This research project is being conducted to look at the safety, tolerability, and pharmacokinetics (PK; how the human body processes a substance) of ETX2514 when given to healthy volunteers intravenously as a single dose, and when given as multiple intravenous doses for up to 8 consecutive days. As it is anticipated that ETX2514 could be used as a treatment for Acinetobacter baumannii (a type of bacteria) infections, this project will also look at whether ETX2514 will interact with the current treatments for these infections when they are administered at the same time.

Timeline

Start
2016-10
Primary completion
2017-06-01
Completion
2017-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cilastatin Small molecule 0.5 g Intravenous
Subject Durlobactam Small molecule 0.25 g Intravenous
Subject Durlobactam Small molecule 0.5 g Intravenous
Subject Durlobactam Small molecule 1 g Intravenous
Subject Durlobactam Small molecule 2 g Intravenous
Subject Durlobactam Small molecule 4 g Intravenous
Subject Durlobactam Small molecule 8 g Intravenous
Subject IMIPENEM ANHYDROUS Small molecule 0.5 g Intravenous
Subject Sulbactam Small molecule 1 g Intravenous