Lomitapide at Supratherapeutic Plasma Levels Does Not Prolong the QTc Interval-Results from a TQT Study with Moxifloxacin and Ketoconazole

Author:

Darpo Borje12,Ferber Georg3,Zhou Meijian1,Sumeray Mark4,Sager Philip5

Affiliation:

1. iCardiac Technologies; Rochester NY

2. Karolinska Institutet, Division of Cardiovascular Medicine; Department of Clinical Sciences, Danderyd's Hospital; Stockholm Sweden

3. Statistik Georg Ferber GmbH; Riehen Switzerland

4. Aegerion Pharmaceuticals; Cambridge MA

5. Sager Consulting Experts, Inc; San Francisco CA

Publisher

Wiley

Subject

Physiology (medical),Cardiology and Cardiovascular Medicine,General Medicine

Reference23 articles.

1. ICH Harmonized Tripartite Guideline E14 The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs 2005 http://www.ich.org/cache/compo/276-254-1.html

2. The thorough QT/QTc study 4 years after the implementation of the ICH E14 guidance;Darpo;Br J Pharmacol,2010

3. Interval prolongation and ICH E14 : The need to get it right;Shah;Drug Saf,2005

4. ICH E14 Questions & Answers 2012 http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_Q_As_R1_step4.pdf

5. Effect of different durations of ketoconazole dosing on the single-dose pharmacokinetics of midazolam: Shortening the paradigm;Stoch;J Clin Pharmacol,2009

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