Infections, Respiratory Tract Clinical Trial
Official title:
A Phase I, Randomized, Double-Blinded, Placebo- and Moxifloxacin-Controlled, 4-Period Crossover Study to Evaluate the Effect of GSK2140944 on Cardiac Conduction as Assessed by 12-lead Electrocardiogram in Healthy Volunteers
This is Phase I, 4-period, randomized, active-and placebo-controlled, double-blind crossover,
single-dose study to evaluate the effects of a therapeutic (1000 milligram [mg]) and
supratherapeutic (1800 mg) dose of GSK2140944 with a positive control (moxifloxacin 400 mg)
and placebo on the corrected QT interval (QTc) as assessed by continuous 12-lead Holter
electrocardiograms (ECGs) in approximately 55 healthy volunteers.
All subjects will receive single doses of GSK2140944 1000 mg, GSK2140944 1800 mg,
moxifloxacin 400 mg, and placebo in a randomized sequence. A double-dummy approach will be
used to maintain blinding. Thus, on each dosing day, moxifloxacin or moxifloxacin placebo and
GSK2140944 or placebo will be administered.
Subjects will be screened within 30 days prior to entry to the clinic. Subjects will report
to the clinical unit on Day -2 of Period 1 and on Day -1 in subsequent periods. Subjects will
remain confined until check out procedures have been completed on Day 3 (5 days confinement
in Period 1 and 4 days in the following 3 periods). There will be a washout of at least 7
days between doses. The follow-up visit will occur 7-10 days after the final dose. Total
duration of the study (from screening to the follow-up visit) will be approximately 60 days.
n/a
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