This is a Phase 1, single centre, randomised, double blind (except for moxifloxacin), placebo and positive controlled, 4 way crossover study assessing the ECG effects of therapeutic and supratherapeutic doses of icosabutate in healthy male and female subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
32
Likely maximum therapeutic dose of NST-4016
Placebo for comparison with moxifloxacin and potential NST-4016 effects
Active comparator with known effect on QT interval
Covance Clinical Research Unit (CRU) Ltd
Leeds, United Kingdom
Change From Baseline in Fridericia's Correction for QT Interval (QTcF)
Electrocardiogram measurement of the maximum absolute change from baseline in Fridericia's correction for QT interval (QTcF)
Time frame: 24 hours
Change From Baseline in Heart Rate (HR)
Electrocardiogram measurement of change from baseline in heart rate (HR) maximum values presented
Time frame: 24 hours
Change From Baseline in Fridericia's Correction for QT Interval (QTcF)
Electrocardiogram measurement of change from baseline in Fridericia's correction for QT interval (QTcF)
Time frame: 24 hours
Change From Baseline in PR Interval (PR)
Electrocardiogram measurement of change from baseline in PR interval (PR)
Time frame: 24 hours
Change From Baseline in QRS Interval (QRS)
Electrocardiogram measurement of change from baseline in QRS interval (QRS)
Time frame: 2 hours
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Supratherapeutic dose of NST-4016