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

NCT03564158 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2019-01-10

No results posted yet for this study

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)

Conditions

  • Healthy

Interventions

DRUG

meropenem-vaborbactam

Meropenem-Vaborbactam being studied for effects on TQT

DRUG

Placebo

Placebo

DRUG

Moxifloxacin

Active Comparator

Sponsors & Collaborators

Principal Investigators

  • Sue Cammarata · Melinta Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2018-11-19
Completion
2018-11-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03564158 on ClinicalTrials.gov