NCT03491748

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Entasis Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ETX0282	Oral Gelatin capsules
DRUG	Cefpodoxime proxetil	Oral tablets
DRUG	Placebo	Oral Gelatin capsules

Timeline

• Start date: 2018-03-16
• Primary completion: 2019-09-11
• Completion: 2019-09-11
• First posted: 2018-04-09
• Last updated: 2020-01-14

Locations

1 site across 1 country: Australia