Tranzyme Reports Positive Results From Postoperative Ileus Study
Tranzyme Pharma has reported positive results from a ‘thorough QT/QTc’ study of its lead product TZP-101, an intravenous gastrointestinal prokinetic agent currently in two Phase IIb trials for the treatment of postoperative ileus and severe gastroparesis.
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.”