Evaluate Effects of Meropenem-Vaborbactam on QT/QTc in Healthy Volunteers

Summary

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)

Timeline

Start

2018-05-01

Primary completion

2018-11-19

Completion

2018-11-19

Drugs

Indications

No indication recorded.