Effects of a new antibacterial, telavancin, on cardiac repolarization (QTc interval duration) in healthy subjects

Journal of Clinical Pharmacology

Volumn 44, Issue 7, 2004, Pages 689-695

  Barriere, Steven ^a   Genter, Fredric ^a   Spencer, Elizabeth ^a   Kitt, Michael ^a   Hoelscher, David ^b   Morganroth, Joel ^c  

^a THERAVANCE INC   (United States)

^b Pharmaceutical Product Development   (United States)

^c UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

Antibacterial; Cardiac repolarization; Drug development; QTc interval prolongation; Telavancin

Indexed keywords

ANTIBIOTIC AGENT; MOXIFLOXACIN; PLACEBO; TELAVANCIN; UNCLASSIFIED DRUG;

ADULT; ANTIBACTERIAL ACTIVITY; ARTICLE; BACTERICIDAL ACTIVITY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORRELATION ANALYSIS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; ELECTROCARDIOGRAM; EVALUATION; EXPERIENCE; FEMALE; GRAM POSITIVE BACTERIUM; HEART RATE; HEART REPOLARIZATION; HUMAN; MAJOR CLINICAL STUDY; MALE; QT INTERVAL; RANDOMIZED CONTROLLED TRIAL; SENSITIVITY ANALYSIS; VALIDATION PROCESS;

ADOLESCENT; ADULT; AMINOGLYCOSIDES; ANTI-BACTERIAL AGENTS; AZA COMPOUNDS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; ELECTROCARDIOGRAPHY; FEMALE; HEART; HUMANS; MALE; QUINOLINES;

EID: 2942657731     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1177/0091270004266620     Document Type: Article

References (8)

1. Fermini B, Fossa AA: The impact of drug-induced QT interval prolongation on drug discovery and development. Nat Rev Drug Discov 2003;2(6):439-447.
2. Food and Drug Administration and Health Canada: The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. Preliminary concept paper, November 15, 2002. Accessed August 7, 2003, from http://www.fda. gov/cder/workshop.htm#upcoming
3. Morganroth J: Relations of QTc prolongation on the electrocardiogram to Torsades de Pointes: definitions and mechanisms. Am J Cardiol 1993;72:10B-13B.
4. Haverkamp W, Breithardt G, Camm AJ, et al: The potential for QT prolongation and proarrhythmia by non-antiarrhythmic drugs: clinical and regulatory implications. Report on a Policy Conference of the European Society of Cardiology. Cardiovasc Res 2000;47(2):219-233.
5. Crouch MA, Limon L, Cassano AT: Clinical relevance and management of drug-related QT interval prolongation. Pharmacotherapy 2003;23:881-908.
6. Pace JL: TD-6424: a novel, multifunctional antibiotic. Abstracts of the 42nd intersci antimicrob agents chemother [abstract 614]. 2002; 46:454.
7. Avelox® [package insert]. West Haven, CT: Bayer Corporation, 2003.
8. Food and Drug Administration: 93rd Meeting of the Cardiovascular and Renal Drug Advisory Committee, Silver Spring, MD, May 23, 2003. Accessed August 7, 2003, from http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3956T1.htm