A Study to Evaluate the Effect of Carbetocin on the QT/QTc Interval in Healthy Subjects
Status:
Completed
Trial end date:
2023-09-21
Target enrollment:
Participant gender:
Summary
Carbetocin is an oxytocin receptor agonist that selectively binds to receptors in the smooth
muscle of the uterus, stimulates rhythmic contractions of the uterus, increases the frequency
of existing contractions, and raises the tone of the uterine musculature. Carbetocin is
approved in >100 countries for the prevention of postpartum hemorrhage due to uterine atony
in women following cesarean or vaginal delivery. Per regulatory requirements, the current
trial will evaluate the effects of high clinical exposure of carbetocin on the QT interval
corrected for heart rate (QTc) as measured by ECG in healthy men and women.