Overview

CiPA Phase 1 ECG Biomarker Validation Study

Status:
Completed
Trial end date:
2017-06-26
Target enrollment:
Participant gender:
Summary
This study will assess whether exposure response analysis of the electrocardiographic QTc and J-Tpeakc intervals in Phase 1 clinical pharmacology studies can be used to confirm that drugs that predominantly block the potassium channel encoded by the human ether-à-go-go-related gene (hERG) with approximately equipotent late sodium and/or calcium block ("balanced ion channel" drugs) do not cause J-Tpeakc prolongation and that drugs that predominantly block hERG without late sodium or L-type calcium current block ("predominant hERG" drugs) cause QTc prolongation.
Phase:
Phase 1
Details
Lead Sponsor:
Food and Drug Administration (FDA)
Collaborator:
Spaulding Clinical Research LLC
Treatments:
Chloroquine
Chloroquine diphosphate
Diltiazem
Dofetilide
Lopinavir
Ranolazine
Ritonavir
Verapamil