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Last Updated: August 4, 2020

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR VABOMERE

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All Clinical Trials for VABOMERE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03564158 Evaluate Effects of Meropenem-Vaborbactam on QT/QTc in Healthy Volunteers Recruiting Biomedical Advanced Research and Development Authority Phase 1 2018-05-01 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)
NCT03564158 Evaluate Effects of Meropenem-Vaborbactam on QT/QTc in Healthy Volunteers Recruiting Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) Phase 1 2018-05-01 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)
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for VABOMERE

Condition Name

Condition Name for VABOMERE
Intervention Trials
Healthy 1
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Condition MeSH

Condition MeSH for VABOMERE
Intervention Trials
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Clinical Trial Locations for VABOMERE

Trials by Country

Trials by Country for VABOMERE
Location Trials
United States 1
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Trials by US State

Trials by US State for VABOMERE
Location Trials
Maryland 1
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Clinical Trial Progress for VABOMERE

Clinical Trial Phase

Clinical Trial Phase for VABOMERE
Clinical Trial Phase Trials
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for VABOMERE
Clinical Trial Phase Trials
Recruiting 1
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Clinical Trial Sponsors for VABOMERE

Sponsor Name

Sponsor Name for VABOMERE
Sponsor Trials
Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) 1
Biomedical Advanced Research and Development Authority 1
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Sponsor Type

Sponsor Type for VABOMERE
Sponsor Trials
U.S. Fed 1
Industry 1
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Serving leading biopharmaceutical companies globally:

McKesson
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Boehringer Ingelheim

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