NCT03709927

4-way Crossover QT Evaluation in Healthy Subjects

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Nabriva Therapeutics AG · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Cardiac Repolarization in Healthy Subjects

Interventions

Type	Name	Description
DRUG	ZTI-01	6g IV fosfomycin
DRUG	Moxifloxacin 400mg	oral moxifloxacin (Avelox 400 mg) + IV normal saline (Placebo)
OTHER	Placebo IV	IV Placebo (0.9% Normal Saline)

Timeline

• Start date: 2018-01-11
• Primary completion: 2018-04-12
• Completion: 2018-08-21
• First posted: 2018-10-17
• Last updated: 2019-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study