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A Thorough QT/QTc Study to Evaluate the Effects of an Intravenous Infusion of Eravacycline (TP-434) on Cardiac Repolarization

NCT01941446 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2021-12-27

No results posted yet for this study

Summary

This is a randomized, placebo- and positive-controlled (moxifloxacin), 3-period, 3-way crossover thorough QT study, which includes a Screening Period, Treatment Periods (1 through 3), and a Follow-up Visit. Subjects will be confined to the investigational site for 4 nights/3 days during Period 1 and for 3 nights/2 days during Periods 2 and 3. There will be a minimum of a 14 day washout between treatments.

Conditions

  • Normal Healthy Subjects

Interventions

DRUG

Eravacyline, Moxifloxacin, and placebo

Sponsors & Collaborators

  • Tetraphase Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Patrick T Horn, MD, PhD · Tetraphase Pharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-06-30
Completion
2013-07-31

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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 NCT01941446 on ClinicalTrials.gov