Evaluate Effects of Meropenem-Vaborbactam on QT/QTc in Healthy Volunteers
Status:
Completed
Trial end date:
2018-11-19
Target enrollment:
Participant gender:
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)
Phase:
Phase 1
Details
Lead Sponsor:
Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
Collaborator:
Biomedical Advanced Research and Development Authority
Treatments:
Meropenem Moxifloxacin Norgestimate, ethinyl estradiol drug combination Thienamycins Vaborbactam