The Effect of a Novel Oral Carbapenem, Tebipenem Pivoxil, on QT Interval

Abstract

We performed a placebo-controlled, double-blinded, 3-way cross-over study to examine the effect of tebipenem pivoxil (TBPM-PI), a novel oral carbapenem antibiotic, on QT interval in 12 healthy male volunteers assigned to three groups: recommended clinical dose, double of recommended dose, and placebo control. TBPM-PI administration did not influence QT intervals, but slightly shortened RR intervals. When the QT intervals were corrected for RR, the corrected QTc-B intervals (=QT/RR^0.5) and QTc-F intervals (=QT/RR^0.33) in the TBPM-PI groups were prolonged at several time points due to shortened RR interval after dosing, compared to the corrected QTcs intervals in the control group. However, the QT intervals corrected with a factor“n”estimated before dosing from all subjects (QTc-N interval=QT/RRⁿ) and the QT intervals corrected with a factor“ni”estimated from individual subjects (QTc-I interval=QT/RRⁿⁱ) were not significantly prolonged at all time points compared to the placebo group. We therefore concluded that TBPM-PI has no evident effect on QT interval prolongation.