Absence of effect of telbivudine on cardiac repolarization: results of a thorough QT/QTc study in healthy participants

• Published in: Journal of clinical pharmacology Vol. 49; no. 12; p. 1436
• Main Authors: Poordad, Fred, Zeldin, Gillian, Harris, Stuart I, Ke, June, Xu, Limin, Mayers, Douglas, Zhou, Xiao-Jian
• Format: Journal Article
• Language: English
• Published: England 01.12.2009
• Subjects: Adult; Antiviral Agents - administration & dosage; Antiviral Agents - adverse effects; Antiviral Agents - blood; Antiviral Agents - pharmacokinetics; Area Under Curve; Body Mass Index; Cross-Over Studies; Electrocardiography - drug effects; Female; Hispanic Americans; Humans; Male; Middle Aged; Nucleosides - administration & dosage; Nucleosides - adverse effects; Nucleosides - blood; Nucleosides - pharmacokinetics; Pyrimidinones - administration & dosage; Pyrimidinones - adverse effects; Pyrimidinones - blood; Pyrimidinones - pharmacokinetics; Sex Characteristics; Statistics as Topic; Thymidine - analogs & derivatives; Young Adult

The effect of telbivudine on cardiac repolarization was evaluated in healthy participants at clinical and supratherapeutic doses. Sixty-two participants were enrolled, stratified by sex, and randomized according to a crossover design among 4 treatment sequences: placebo, a single moxifloxacin 400-mg...