drugset / Trial / NCT01941446
A Thorough QT/QTc Study to Evaluate the Effects of an Intravenous Infusion of Eravacycline (TP-434) on Cardiac Repolarization
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eravacycline | Small molecule | 1.5 mg/kg | Intravenous |
| Subject | Moxifloxacin | Small molecule | 400 mg | Oral |
Indications
No indication recorded.