NCT05924321

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

A Randomized, 2-Part, Crossover Trial to Evaluate the Effect of Carbetocin on the QT/QTc Interval in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Postpartum Hemorrhage

Interventions

Type	Name	Description
DRUG	Carbetocin	Single infusion of Carbetocin
DRUG	Placebo	Single IV infusion of matching placebo
DRUG	Placebo and Moxifloxacin	Single IV infusion of matching placebo in combination with Single Oral dose of Moxifloxacin

Timeline

• Start date: 2023-05-25
• Primary completion: 2023-09-21
• Completion: 2023-09-21
• First posted: 2023-06-29
• Last updated: 2024-09-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study