The study, required by the FDA for all new chemical entities, was conducted to evaluate the cardiac safety of TZP-101, with a focus on cardiac repolarization as measured by the duration of the QT interval in serial electrocardiograms (ECG).
The trial was a double-blind, randomized, parallel study which compared the ECG effects of TZP-101, given at a therapeutic (160 micrograms/kilogram daily for five days) and a supratherapeutic dose (600 micrograms/kilogram daily for five days), to placebo and moxifloxacin (a positive control known to increase the QT interval) in 160 healthy men and women.
The primary analysis was centered on a time-matched change from baseline in corrected QT interval (QTc) based on an individual correction method.
Gordana Kosutic, vice president of clinical and regulatory affairs at Tranzyme, said: “The results further demonstrate that TZP-101 has no effect on heart rate, PR and QRS interval duration or cardiac morphology, and thus continue to substantiate the compound’s pronounced cardiovascular safety profile.”