This study will evaluate the effect of oral GS-6615 on QTc interval in healthy adults with dofetilide-induced QTc prolongation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
GS-6615 tablets administered orally
Placebo to match GS-6615 tablets administered orally
Placebo to match dofetilide capsules administered orally
Spaulding Clinical Research, LLC
West Bend, Wisconsin, United States
Change in daytime QT interval corrected for heart rate using the Fridericia formula (QTcF)
Time frame: Up to 6 days
Pharmacokinetic (PK) profiles of GS-6615 and dofetilide
This endpoint will measure the plasma PK profiles of GS-6615 and dofetilide. PK parameters that will be measured include Cmax, Tmax, AUC\_0-24, and AUC\_0-tlast.
Time frame: Predose and postdose on Days -2 through Day 4
Incidence of adverse events, clinical laboratory test results, vital sign measurements, and electrocardiogram (ECG) data
This endpoint will measure the safety and tolerability profile of GS-6615.
Time frame: Up to 6 days
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Dofetilide 500 μg capsules administered orally according to the current prescribing information