This study will evaluate the effect of a single dose of bepirovirsen on the QT interval corrected by Fridericia's formula (QTcF) as compared to placebo. The data generated will be used to model the relationship between bepirovirsen concentration and QTcF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
46
Bepirovirsen will be administered.
Placebo will be administered.
GSK Investigational Site
Austin, Texas, United States
Change from Baseline in QT interval corrected by Fridericia's formula (QTcF)
Time frame: Baseline (Day 1) and up to Day 4
Change from Baseline in heart rate (HR) using by-time point analysis
Time frame: Baseline (Day 1) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose
Change from Baseline in QT interval, corrected by Fridericia's formula (QTcF), using by-time point analysis
Time frame: Baseline (Day 1) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose
Change from Baseline in PR interval using by-time point analysis
Time frame: Baseline (Day 1) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose
Change from Baseline in QRS duration using by-time point analysis
Time frame: Baseline (Day 1) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose
Number of participants with outlier results for QT interval, corrected by Fridericia's formula (QTcF), HR, PR and QRS
Time frame: Up to Day 4
Number of participants with treatment emergent changes of T wave morphology and U-wave presence
Time frame: Up to Day 4
Plasma concentrations of Bepirovirsen
Time frame: Up to Day 4
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinity]) of Bepirovirsen
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Time frame: Up to Day 4
Area under the concentration-time curve from time zero (pre-dose) to 24 hours post-dose (AUC[0-24]) of Bepirovirsen
Time frame: Up to 24 hours
Maximum concentration (Cmax) of Bepirovirsen in plasma
Time frame: Up to Day 4
Time to reach Cmax (Tmax) of Bepirovirsen
Time frame: Up to Day 4