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Effects of therapeutic and supratherapeutic doses of oral tedizolid phosphate on cardiac repolarisation in healthy volunteers: a randomised controlled study.
- Source :
-
International Journal of Antimicrobial Agents . Jul2016, Vol. 48 Issue 1, p33-40. 8p. - Publication Year :
- 2016
-
Abstract
- Drug-induced prolongation of the QT interval on the electrocardiogram (ECG) infrequently results in Torsades de pointes, a potentially fatal arrhythmia. Therefore, thorough QT analysis of new drugs is a regulatory requirement. The objective of this phase 1 study was to assess the effects of oral tedizolid phosphate on the QT interval corrected with Fridericia's formula (QTcF) in healthy adult subjects. A single therapeutic dose (200 mg) and a supratherapeutic dose (1200 mg) of tedizolid phosphate were administered to characterise QTc changes following typical systemic exposure and with markedly higher exposures, respectively. This was a four-way crossover study with 48 subjects randomly assigned to receive therapeutic and supratherapeutic doses of tedizolid phosphate, moxifloxacin (positive control for QT interval prolongation) and placebo (negative control). A continuous 12-lead ECG was recorded from 1 h before drug administration to 23 h after administration. Adverse events, which were generally mild, occurred most frequently with moxifloxacin or with a supratherapeutic dose of tedizolid phosphate; however, all treatments were well tolerated. This study demonstrated that therapeutic or supratherapeutic doses of the antibacterial tedizolid had no clinically significant effect on QT interval in healthy adults [ ClinicalTrials.gov registration no.: NCT01461460]. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 09248579
- Volume :
- 48
- Issue :
- 1
- Database :
- Academic Search Index
- Journal :
- International Journal of Antimicrobial Agents
- Publication Type :
- Academic Journal
- Accession number :
- 116575678
- Full Text :
- https://doi.org/10.1016/j.ijantimicag.2015.12.015