The purpose of this study is to investigate the effects of tafamidis on the intervals of the electrocardiogram, specifically the rate corrected QT interval (QTc) in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
42
A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.
A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.
A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.
Pfizer Investigational Site
New Haven, Connecticut, United States
Pfizer Investigational Site
Brussels, Belgium
Pfizer Investigational Site
Singapore, Singapore, Singapore
QTc interval using Fridericia's correction method (QTcF) of tafamidis and placebo (baseline-adjusted) at each post-dose time
Time frame: SCRN, -1, -0.5, 0, 1, 1.5, 2, 3, 4, 6, 12, 24 hrs
QTcF of moxifloxacin and placebo at historical moxifloxacin median Tmax of 3 hours.
Time frame: Scrn, -1, -0.5, 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs
Tmax
Time frame: 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs
Cmax
Time frame: 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs
AUC0-24
Time frame: 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs
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