KUBITZA D, DELESEN H; Interscience Conference on Antimicrobial Agents and Chemotherapy.
Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2000 Sep 17-20; 40: 475.
Bayer AG, Pharma Res. Ctr., Dept. Pharmacodynamics, Wuppertal, Germany
Moxifloxacin (MFX) is a new broad spectrum antibiotic. Since a QTc interval prolonging effect has been demonstrated for sparfloxacin, these ECG changes are becoming recognized as another potential side effect of the new quinolones. Therefore, the potential of MFX to induce a relevant QTc prolongation was investigated. ECGs of 140 healthy male volunteers (HMV) on MFX receiving single doses (SD) of 50 to 800 mg and 100 mg bid to 600 mg once daily multiple dose were analyzed in 11 studies. In five of these studies 46 volunteers received placebo (PL). A small and asymptomatic QTc prolongation was found. The mean QTc prolongation at the assumed C[max] after administration of 400 mg SD was 6.9 msec, with a corresponding PL value of 3.5 msec. As individual rather than mean values represent clinical relevance of a QTc prolongation, parameters have been defined which identify subjects that are more sensitive to a QTc prolonging effect of a drug. Analysis of the phase I data did not demonstrate any difference of frequencies of significant outliers between MFX and PL. In conclusion, despite of a small and asymptomatic prolongation of the mean QTc interval, no difference exists for frequencies of outliers between MFX and PL suggesting no clinically relevant effect in HMV [table: see text].KEYWORDS: ECG; Moxifloxacin; Volunteers
Publication Types:
Keywords:
- Anti-Bacterial Agents
- Aza Compounds
- Electrocardiography
- Fluoroquinolones
- Male
- Quinolines
- moxifloxacin
- sparfloxacin
Other ID:
UI: 102248194
From Meeting Abstracts