4-way Crossover QT Evaluation in Healthy Subjects

Cardiac Repolarization in Healthy Subjects Clinical Trial

Official title: A Phase 1, Randomized, Blinded, Placebo and Moxifloxacin Controlled, 4-Period Crossover, Study Evaluating the Effect of ZTI-01 on 12-Lead Electrocardiogram Parameters in Healthy Adult Subject

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate if ZTI-01 (fosfomycin for injection), an investigational drug being developed to treat people with complicated urinary tract and kidney infections, has any effect on the electrical activity of the heart.

Clinical Trial Description

This is a single-center, randomized, placebo-controlled, four-period, cross-over study to assess the effect of single-doses of ZTI-01 at therapeutic (T) and supratherapeutic (ST) plasma concentrations on the QTc interval versus placebo (P) and an open-label moxifloxacin (M) control (400 mg PO).

Assessment of safety data will include changes from baseline in vital signs and laboratory parameters, infusion site reactions, adverse events and clinically significant changes from baseline in 12-lead ECG parameters. ;

Related Conditions & MeSH terms

• Cardiac Repolarization in Healthy Subjects

• NCT number: NCT03709927
• Study type: Interventional
• Source: Nabriva Therapeutics AG
• Status: Completed
• Phase: Phase 1
• Start date: January 11, 2018
• Completion date: August 21, 2018