Pharmacokinetics Clinical Trial
Official title:
Comprehensive in Vitro Proarrhythmia Assay (CiPA) Clinical Phase 1 ECG Biomarker Validation Study (CiPA Phase 1 ECG Biomarker Study)
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.
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
"balanced ion channel" drugs do not cause J-Tpeakc prolongation and that "predominant hERG"
drugs cause QTc prolongation. This clinical study consists of 2 parts: a 50-subject parallel
part (Part 1) and a 10-subject crossover part (Part 2). Up to 74 healthy subjects will be
enrolled (including 14 potential replacement subjects).
Part 1 will be a double-blind, randomized, placebo-controlled, 1 period parallel design to
assess the effect of 4 marketed drugs and 1 placebo on the QTc and J-Tpeakc intervals in 50
healthy subjects. A parallel design similar to a single or multiple ascending dose (SAD/MAD)
Phase 1 study will be used that will result in each study drug being administered to 10
subjects, and placebo to 10 subjects, in 1 period of 3 consecutive days to achieve low and
high drug exposure.
Part 2 will be a double-blind, randomized, 2-period crossover design to assess the effect of
hERG block (dofetilide) versus calcium block (diltiazem) on the QTc and J-Tpeakc intervals in
10 healthy subjects on Days 1, 2, and 3 (Period 1) and Days 8, 9, and 10 (Period 2).
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