NCT03564158

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

A Randomized, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Effect of Meropenem-Vaborbactam on the QT/QTc Interval in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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)

Detailed description

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)

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	meropenem-vaborbactam	Meropenem-Vaborbactam being studied for effects on TQT
DRUG	Placebo	Placebo
DRUG	Moxifloxacin	Active Comparator

Timeline

• Start date: 2018-05-01
• Primary completion: 2018-11-19
• Completion: 2018-11-19
• First posted: 2018-06-20
• Last updated: 2019-01-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study