A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK, the Measure of How the Human Body Processes a Substance) of ETX0282 When Administered Orally to Healthy Participants

Healthy Volunteers Clinical Trial

Official title: A Phase 1, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral ETX0282 Administered in Healthy Subjects

Status Completed

Clinical Trial Summary

This research project is being conducted to investigate the safety, tolerability, and pharmacokinetics (PK) of a single ascending dose (SAD) and multiple ascending doses (MAD) of oral ETX0282 when administered alone and in combination with cefpodoxime proxetil in healthy adult participants.

Clinical Trial Description

This Phase 1, single-center, double-blind, randomized, placebo-controlled study will be conducted to:

• Determine the safety and tolerability of oral ETX0282 when administered as a SAD and MAD to healthy participants;

• Determine the safety and tolerability of oral ETX0282 when administered as a single oral dose in combination with cefpodoxime proxetil to healthy participants;

• Characterize the PK in plasma and in urine of ETX0282 and ETX1317 following administration of single and multiple oral doses of ETX0282 in healthy participants; and

• Determine the PK profile in plasma and in urine of ETX0282 and ETX1317 and of cefpodoxime proxetil and cefpodoxime following administration of single oral doses of ETX0282 and cefpodoxime proxetil alone and when ETX0282 is co-administered with cefpodoxime proxetil at the same time as single oral doses in healthy participants. ;

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT03491748
• Study type: Interventional
• Source: Entasis Therapeutics
• Status: Completed
• Phase: Phase 1
• Start date: March 16, 2018
• Completion date: September 11, 2019