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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.
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
GSK1349572 250 mg, Placebo Suspension, Moxifloxacin 400 mg
GSK Investigational Site
Published on BioPortfolio: 2014-08-27T03:18:39-0400
To determine safety, tolerability and pharmacokinetics of GSK1349572
GSK1349572 is an integrase inhibitor that is currently in Phase 2 clinical trials for the treatment of HIV infection. As GSK1349572 development progresses, it may be dosed with non-nucleo...
GSK1349572 is an integrase inhibitor that is currently being evaluated for the treatment of HIV infection. The primary objective of this study is to determine whether the addition of a pr...
A study in healthy volunteers to determine whether there is a drug interaction between GSK1349572 and the HIV protease inhibitors lopinavir/ritonavir and darunavir/ritonavir
A study in healthy volunteers to determine whether there is a drug interaction between GSK1349572 and etravirine
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Effects of moxifloxacin on QTc as well as proarrhythmic surrogate markers including J-Tc, T-Tand short-term variability (STV) of repolarization were examined by using both standard E14 time-based eval...
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Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Positive test results in subjects who do not possess the attribute for which the test is conducted. The labeling of healthy persons as diseased when screening in the detection of disease. (Last, A Dictionary of Epidemiology, 2d ed)
Negative test results in subjects who possess the attribute for which the test is conducted. The labeling of diseased persons as healthy when screening in the detection of disease. (Last, A Dictionary of Epidemiology, 2d ed)
Books intended for use in the study of specific subjects, containing systematic presentation of the principles and essential knowledge of the subjects.
Human experimentation that is not intended to benefit the subjects on whom it is performed. Phase I drug studies (CLINICAL TRIALS, PHASE I AS TOPIC) and research involving healthy volunteers are examples of nontherapeutic human experimentation.
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The Top 100 Pharmaceutical Companies
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