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

Normal Healthy Subjects Clinical Trial

Official title: A Randomized, Placebo- and Positive Controlled, Three-Way, Crossover Study to Evaluate the Effects of an Intravenous Infusion of Eravacycline (TP-434) on Cardiac Repolarization in Healthy Male and Female Subjects: A Thorough QT/QTc Study

Status Completed

Clinical Trial 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.

Clinical Trial Description

Each of the following treatments will be evaluated on Day 1 of each period in a crossover fashion. The IV eravacycline (TP-434) and IV placebo will be double-blinded.

• Treatment A: Eravacycline (TP-434) 1.5 mg/kg administered intravenously over 60 minutes and one placebo oral tablet;

• Treatment B: Placebo (0.9% sodium chloride) administered intravenously over 60 minutes and one moxifloxacin 400 mg oral tablet; and

• Treatment C: Placebo (0.9% sodium chloride) administered intravenously over 60 minutes and one placebo oral tablet.

Subjects will be randomized to a treatment sequence according to a pre-generated treatment scheme. Subjects will receive a different treatment during each of the 3 periods. ;

Related Conditions & MeSH terms

• Normal Healthy Subjects

• NCT number: NCT01941446
• Study type: Interventional
• Source: La Jolla Pharmaceutical Company
• Status: Completed
• Phase: Phase 1
• Start date: March 2013
• Completion date: July 2013