This will be a randomized, partial-blind, placebo-controlled, single dose, cross-over trial investigating the effect of GSK1349572 on cardiac repolarization as compared to placebo in healthy adult males and females. Approximately 42 subjects will be enrolled in this study and will be admitted to the clinic for three separate dosing sessions. Subjects will receive single dose administrations of placebo, a supratherapeutic dose of GSK1349572 (250 mg), and moxifloxacin (400 mg) in random sequence. Safety of subjects will be monitored by clinical observation, measures of vital signs, 12-lead ECGs and clinical laboratory measurements.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
42
This is an experimental HIV medication in the integrase inhibitor class.
Placebo is a liquid with no drug in it.
This is an FDA approved antibiotic in the fluoroquinolone class.
GSK Investigational Site
Baltimore, Maryland, United States
Change from baseline in QTcF for GSK1349572.
Time frame: 24 hours
Safety and tolerability of GSK1349572 as assessed by 12-lead ECGs, vital signs, adverse events, and clinical laboratory tests.
Time frame: 24 hours
Change from baseline in QTcB, QTci, QT, and HR for GSK1349572
Time frame: 24 hours
Change from baseline in QTcF, QTcB, QTci, QT, and HR for placebo
Time frame: 24 hours
Change from baseline in QTcF, QTcB, QTci, QT, and HR for moxifloxacin
Time frame: 24 hours
AUC(0-24), AUC(0-t), AUC(0-tau), Cmax, tmax, CL/F, Vdz/F, and t1/2 from plasma concentrations of GSK1349572 and moxifloxacin (if needed)
Time frame: 24 hours
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