Approximately 40 healthy subjects will be enrolled. Each subject will participate in the study for approximately 9 weeks. There will be four treatment sequences with a 5-7 day washout between treatments. Subjects will be admitted to the clinical unit on Day-1 of each dosing period and will remain in the unit until Day 2. Each subject will receive a single dose of each of the four treatments on Day 1 of each treatment period in a randomized fashion. Subjects will be discharged from the clinical research unit after the completion of all assessments on Day 2 of each period and return approximately 5-7 days later for the next dose period. Serial pharmacokinetic samples will be collected for up to 24 hours following each treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
40
zanamivir 600 mg IV over 30 min x 1 dose + moxifloxacin placebo administered orally x 1 dose
zanamivir 1200 mg IV over 30 min x 1 dose + moxifloxacin placebo administered orally x 1 dose
zanamivir placebo IV over 30 min x 1 dose + moxifloxacin placebo administered orally x 1 dose
moxifloxacin 400 mg administered orally x 1 dose + zanamivir placebo IV over 30 min x 1 dose
GSK Investigational Site
Austin, Texas, United States
Change from baseline in QTcF for zanamivir
Time frame: 9 weeks
Change from baseline in QTcB
Time frame: 9 weeks
Change from baseline in QTci
Time frame: 9 weeks
Change from baseline in QT
Time frame: 9 weeks
Change from baseline in Heart Rate
Time frame: 9 weeks
Pharmacokinetic parameters of Area under the concentration-time curve from time zero (pre-dose) to time of last quantifiable concentration from serum zanamivir concentration-time data
Time frame: 9 weeks
Pharmacokinetic parameters of Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time from serum zanamivir concentration-time data
Time frame: 9 weeks
Pharmacokinetic parameters of maximum observed concentration from serum zanamivir concentration-time data
Time frame: 9 weeks
Pharmacokinetic parameters of time of occurrence of cmax from serum zanamivir concentration-time data
Time frame: 9 weeks
Pharmacokinetic parameters of systemic clearance of parent drug from serum zanamivir concentration-time data
Time frame: 9 weeks
Pharmacokinetic parameters of volume of distribution in terminal phase from serum zanamivir concentration-time data
Time frame: 9 weeks
Pharmacokinetic parameters of terminal phase half-life from serum zanamivir concentration-time data
Time frame: 9 weeks
Pharmacokinetic parameters of Area under the concentration-time curve from time zero (pre-dose) to time of last quantifiable concentration (if needed) from plasma moxifloxacin concentration-time data
Time frame: 9 weeks
Pharmacokinetic parameters of area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (if needed) from plasma moxifloxacin concentration-time data
Time frame: 9 weeks
Pharmacokinetic parameters of maximum observed concentration (if needed) from plasma moxifloxacin concentration-time data
Time frame: 9 weeks
Pharmacokinetic parameters of time of occurrence of cmax (if needed) from plasma moxifloxacin concentration-time data
Time frame: 9 weeks
Pharmacokinetic parameters of systemic clearance of parent drug (if needed) from plasma moxifloxacin concentration-time data
Time frame: 9 weeks
Pharmacokinetic parameters of volume of distribution in terminal phase (if needed) from plasma moxifloxacin concentration-time data
Time frame: 9 weeks
Pharmacokinetic parameters of terminal phase half-life (if needed) from plasm moxifloxacin concentration-time data
Time frame: 9 weeks
Safety and tolerability of zanamivir as assessed by change from baseline in 12-lead Electrocardiograms (ECG)
Time frame: 9 weeks
Safety and tolerability of zanamivir as assessed by change from baseline in blood pressure and heart rate
Time frame: 9 weeks
Safety and tolerability of zanamivir as assessed by change from baseline in the collection of adverse events
Time frame: 9 weeks
Safety and tolerability of zanamivir as assessed by change from baseline in toxicity grading of clinical laboratory tests
Time frame: 9 weeks
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