This is a 2-part, drug-drug interaction study to evaluate potential PK interactions after single doses in Part 1 and multiple doses in Part 2. In Part 1, subjects will receive single dose of 5 treatments in a cross-over design; in Part 2 subjects will receive treatment for 10 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
42
β-lactamase inhibitor
Approved β-lactam antibiotic
Approved antibiotic and antiprotozoal medication
PRAHS
Lenexa, Kansas, United States
Peak Plasma Concentration (Cmax) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A)
Cmax
Time frame: 0-48 hours
Area under the plasma concentration versus time curve (AUC) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A)
AUCinf
Time frame: 0-48 hours
Peak Plasma Concentration (Cmax) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B)
Cmax
Time frame: 0-48 hours
Area under the plasma concentration versus time curve (AUC) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B)
AUCinf
Time frame: 0-48 hours
Number of Subjects with Treatment Emergent Adverse Events
TEAEs based on patient reporting, physical exams, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.
Time frame: First dose to 7 days after last dose: Part 1: 20 days / Part 2: 17 days
Accumulation of VNRX-5133 + VNRX-5022 following multiple dose administration
Trough concentration levels from Day 1 - Day 10
Time frame: Part 2: 10 days
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Placebo (matching VNRX-5133 + VNRX-5022)