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

NCT05924321 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-09-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Compliance · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-25
Primary Completion
2023-09-21
Completion
2023-09-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05924321 on ClinicalTrials.gov