Overview

Study of the Electrocardiographic Effects of Ranolazine, Dofetilide, Verapamil, and Quinidine in Healthy Subjects

Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
This study seeks to compare 4 known QT prolonging drugs versus placebo to determine their effects on electrophysiological and other clinical parameters. The underlying purpose is to determine if depolarization and repolarization effects caused by drugs with differing ionic channel mechanisms can be distinguished from one another, and to gauge the sensitivity and specificity of novel signal analyses for detection of depolarization and repolarization changes. Secondarily, to evaluate the exposure response relationship and drug induced effects on the heart rate biomarker relationship.
Phase:
Phase 1
Details
Lead Sponsor:
Food and Drug Administration (FDA)
Collaborator:
Spaulding Clinical Research LLC
Treatments:
Dofetilide
Quinidine
Quinidine gluconate
Ranolazine
Verapamil