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4-way Crossover QT Evaluation in Healthy Subjects

NCT03709927 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2019-03-06

No results posted yet for this study

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.

Conditions

  • Cardiac Repolarization in Healthy Subjects

Interventions

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)

Sponsors & Collaborators

  • Nabriva Therapeutics AG

    lead INDUSTRY

Principal Investigators

  • Evelyn J Ellis-Grosse, PhD · Chief Scientific Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-11
Primary Completion
2018-04-12
Completion
2018-08-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03709927 on ClinicalTrials.gov