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A Study to Assess the Effects of Epetraborole on the QT Interval in Healthy Adult Subjects

30-abr-2023
A single-center, 4-way crossover study to evaluate the effect of single therapeutic and supratherapeutic oral doses of epetraborole on the heart rate (HR) corrected QT interval (QTc) by assessing...
Nombre completo:
A Phase 1, Single-Dose, Randomized, Placebo- and Positive-Control, Four-Way, Crossover Study for the Evaluation of the Effect of Epetraborole on QT Intervals in Healthy Adult Subjects
No. de registro:
NCT05995444
Apertura / Cierre:
16-ago-2016 al 16-ago-2028
Patrocinador:
AN2 Therapeutics, Inc
Fase:
Estado:
Acrónimo:
Indicación:

On Day 1 of each period, subjects will receive 1 of 4 treatments: a single therapeutic dose of epetraborole (Treatment A), a single supratherapeutic dose of epetraborole (Treatment B), a single dose of epetraborole-matching placebo (Treatment C), or a single dose of moxifloxacin (Treatment D). Cardiodynamic ECGs and PK blood samples for epetraborole, metabolite M3, and moxifloxacin (as applicable) will be collected predose and for 24 hours postdose in each period.nnThere will be a washout of at least 10 days between doses.

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