Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT03564158
Status:
COMPLETED
Last Update Posted:
2019-01-10
First Post:
2018-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate Effects of Meropenem-Vaborbactam on QT/QTc in Healthy Volunteers
Sponsor:
Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
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)
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)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: