Selections of Subjects With Important Changes in Their Cardiac Repolarization Parameters for the Procurement of Skin and Blood Samples

Phase 1 Completed 130 enrolled Ectycell SASU Institut National de la Santé Et de la Recherche Médicale, France · collab Pierre and Marie Curie University · collab

RandomizedCrossoverTriple-blind

Summary

The study main objective is to assess the changes in the ventricular repolarization (measure by the delta QTcf) after drug induced stimulation, compare to placebo, in order to identify subjects with extreme responses and collecting their skin and blood samples.

Timeline

Start: 2011-03
Primary completion: 2011-05
Completion: 2011-08

Publications

Stillitano F, Hansen J, Kong CW, Karakikes I, Funck-Brentano C, Geng L, Scott S, Reynier S, Wu M, Valogne Y, Desseaux C, Salem JE, Jeziorowska D, Zahr N, Li R, Iyengar R, Hajjar RJ, Hulot JS. Modeling susceptibility to drug-induced long QT with a panel of subject-specific induced pluripotent stem cells. Elife. 2017 Jan 30;6:e19406. doi: 10.7554/eLife.19406.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Erythromycin	Small molecule	4 mg/kg	Intravenous

Indications

No indication recorded.