drugset / Trial / NCT01941446

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

NCT01941446

Phase 1 Completed 54 enrolled Tetraphase Pharmaceuticals, Inc
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2013-03
Primary completion
2013-06
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Eravacycline Small molecule 1.5 mg/kg Intravenous
Subject Moxifloxacin Small molecule 400 mg Oral

Indications

No indication recorded.