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

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2018
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)
Epistemonikos ID: 189453d7f10eb2ae623b63c53d4909a32ff91b9d
First added on: May 21, 2024