Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05924321
Status:
COMPLETED
Last Update Posted:
2023-09-26
First Post:
2023-05-03
Brief Title:
A Study to Evaluate the Effect of Carbetocin on the QTQTc Interval in Healthy Subjects
Sponsor:
Ferring Pharmaceuticals
Organization:
Ferring Pharmaceuticals
Study Overview
Official Title:
A Randomized 2-Part Crossover Trial to Evaluate the Effect of Carbetocin on the QTQTc Interval in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None