A Study to Evaluate the Effect of Carbetocin on the QT/QTc Interval in Healthy Subjects

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.

Timeline

Start

2023-05-25

Primary completion

2023-09-21

Completion

2023-09-21

Drugs

Indications

No indication recorded.