Healthy Clinical Trial
Official title:
A Randomized, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Effect of Meropenem-Vaborbactam on the QT/QTc Interval in Healthy Volunteers
This Thorough-QT (TQT) study in healthy volunteers will be conducted in two phases. Phase One
will be used to identify a safe supratherapeutic dose to be used in the TQT study (Phase
Two). Phase Two will be a 4-way crossover TQT study. Thirty-two subjects will receive all 4
of the following treatments in randomized sequence.
1. meropenem-vaborbactam 4 g (meropenem 2 g- vaborbactam 2 g) therapeutic dose infused
intravenously over 3 hours
2. meropenem-vaborbactam supratherapeutic dose to be determined infused intravenously over
3 hours.
3. Placebo (normal saline) to match meropenem-vaborbactam volume infusion over 3 hours
4. Moxifloxacin 400 mg positive control (oral; open-label)
This Thorough-QT (TQT) study in healthy volunteers will be conducted in two phases. Phase One
(n=15) will be used to identify a safe supratherapeutic dose to be used in the TQT study
(Phase Two). Phase Two will be a randomized, placebo and positive-controlled, 4-way crossover
TQT study. Thirty-two subjects will receive all 4 of the following treatments in randomized
sequence.
1. meropenem-vaborbactam 4 g (meropenem 2 g- vaborbactam 2 g) therapeutic dose infused
intravenously over 3 hours
2. meropenem-vaborbactam supratherapeutic dose to be determined infused intravenously over
3 hours.
3. Placebo (normal saline) to match meropenem-vaborbactam volume infusion over 3 hours
4. Moxifloxacin 400 mg positive control (oral; open-label)
;
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