Absence of effect of steady state bempedoic acid on cardiac repolarization: Results of a thorough QT/QTc study in healthy volunteers

Author:

Amore Benny M.1,Cramer Clay T.2,MacDougall Diane E.1,Sasiela William J.1,Emery Maurice G.1

Affiliation:

1. Esperion Therapeutics, Inc. Ann Arbor Michigan USA

2. Nonclinical Pharma Solutions, LLC Dexter Michigan USA

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Reference15 articles.

1. Drug-induced QT interval prolongation: mechanisms and clinical management

2. The significance of QT interval in drug development

3. Relationships between preclinical cardiac electrophysiology, clinical QT interval prolongation and torsade de pointes for a broad range of drugs: evidence for a provisional safety margin in drug development

4. US Food and Drug Administration.Guidance for industry: S7B nonclinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceutical use;2005.https://www.fda.gov/media/72043/download. Accessed July 29 2020.

5. US Food and Drug AdministrationGuidance for Industry: E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non‐antiarrhythmic Drugs; 2005.https://www.fda.gov/media/71372/download.Accessed July 29 2020.

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