This study has been designed to investigate the effect of lersivirine on the QT/QTc interval in order to help establish the safety profile of lersivirine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
66
Lersivirine 2400 mg single dose
Placebo single dose
Lersivirine 2100 mg single dose (if necessary)
Pfizer Investigational Site
Brussels, Belgium
(Part A) To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects.
Time frame: 1 day
(Part B) To demonstrate a lack of effect of lersivirine on QTc relative to time-matched placebo.
Time frame: 3 days
To determine study sensitivity by comparing the effect of moxifloxacin on QTc relative to time-matched placebo, at the historical moxifloxacin Tmax of 3 hours.
Time frame: 1 day
To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects.
Time frame: 1 day
To characterize the exposure-response relationship between lersivirine and changes in QTc using plasma concentrations of lersivirine.
Time frame: 1 day
To assess the single dose pharmacokinetics of lersivirine.
Time frame: 1 - 2 days
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Lersivirine 2400 mg single dose (dose may be decreased pending Part A tolerability results)
Placebo single dose
Moxifloxacin 400 mg single dose