A Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
60
FEP-ZID IV solution administered as either a 30- or 60-minute IV infusion)
Placebo (IV placebo matched to FEP-ZID IV solution) and 1 placebo capsule matched to moxifloxacin overencapsulated tablet
Moxifloxacin 400-mg positive control (overencapsulated tablet)
Spaulding Clinical Research
West Bend, Wisconsin, United States
Incidence of delay in cardiac repolarization induced by WCK 5222
as shown by analysis of the QT interval.
Time frame: 0-4 days
Incidence of adverse events to assess tolerability at the supratherapeutic dose to be used in the thorough QT evaluation
Tolerability will be assessed by review of number of AEs
Time frame: 0-4 days
Incidence of AEs to assess the safety of high doses of single-dose administration of FEP-ZID
Safety will be assessed by review of adverse events (AEs), ECGs, and clinical laboratory safety test results
Time frame: 0-4 days
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