DRUG
Carbetocin
Single infusion of Carbetocin
A Study to Evaluate the Effect of Carbetocin on the QT/QTc Interval in Healthy Subjects
Status
Completed
Phase
Phase 1
Enrollment
40
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
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
From registration to results.
First posted
Jun 29, 2023
Study start
May 25, 2023
Primary completion
Sep 21, 2023
Study completion
Sep 21, 2023
Results posted
Not reported
Registry updated
Sep 3, 2024
Outcomes
What the study measures.
Primary outcomes
Observed Heart rate(HR) values
Time frame · Up to 240 minutes after Start of Infusion
Part A
Change from baseline of HR (∆HR).
Time frame · Up to 240 minutes after Start of Infusion
Part A
Placebo-corrected change from baseline in QT interval (∆∆QTc) using the most appropriate HR correction method (i.e., ∆∆QTcF if Fridericia's method is used).
Time frame · Up to 24 hours after Start of Infusion
Part B
Secondary outcomes
Treatment-emergent adverse events (TEAEs)
Time frame · Up to follow-up visit (7 to 10 days after the last dose)
Part A
Vital signs; Systolic blood pressure and Diastolic blood pressure
Time frame · Up to follow-up visit (7 to 10 days after the last dose)
Part A. The parameters which are measured are Systolic blood pressure and Diastolic blood pressure. Each vital sign parameter value is classified as either Low, Normal or High. Summary tables will be prepared by treatment displaying the number and percentage of subjects with normal pre-administration values who had at least one markedly abnormal post-administration values.
Vital signs; Pulse rate
Time frame · Up to follow-up visit (7 to 10 days after the last dose)
Part A. The parameter which is measured is Pulse rate. The vital sign parameter value is classified as either Low, Normal or High. Summary tables will be prepared by treatment displaying the number and percentage of subjects with normal pre-administration values who had at least one markedly abnormal post-administration values.
Vital signs; Body temperature
Time frame · Up to follow-up visit (7 to 10 days after the last dose)
Part A. The parameter which is measured is Body temperature. The vital sign parameter value is classified as either Low, Normal or High. Summary tables will be prepared by treatment displaying the number and percentage of subjects with normal pre-administration values who had at least one markedly abnormal post-administration values.
Vital signs; Respiratory rate
Time frame · Up to follow-up visit (7 to 10 days after the last dose)
Part A. The parameter which is measured is Respiratory rate. The vital sign parameter value is classified as either Low, Normal or High. Summary tables will be prepared by treatment displaying the number and percentage of subjects with normal pre-administration values who had at least one markedly abnormal post-administration values.
12-lead safety ECGs
Time frame · Up to follow-up visit (7 to 10 days after the last dose)
Part A. The parameters which are measured are QT, QTc, QTcF, QRS, PR, RR and HR. Subjects' maximum change from baseline and subject's maximum post-baseline values in ECG parameters will be categorized and the number and percentage of subjects in each group will be summarized. The results will be interpreted as "normal", "abnormal, not clinically significant" or "abnormal clinically significant", and the interpretation will be summarized for each treatment and scheduled time point using frequency counts and percentages.
Clinical chemistry: Changes in Concentration of Blood Urea Nitrogen
Time frame · Up to follow-up visit (7 to 10 days after the last dose)
Part A. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Bilirubin Total
Time frame · Up to follow-up visit (7 to 10 days after the last dose)
Part A. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Bilirubin direct
Time frame · Up to follow-up visit (7 to 10 days after the last dose)
Part A. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Alkaline phosphatase
Time frame · Up to follow-up visit (7 to 10 days after the last dose)
Part A. Assessed by blood sample collection
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Sex
- ALL
- Healthy volunteers
- Yes
Inclusion Criteria: * Healthy, adult, male or female subjects, 18-45 years of age, inclusive, at the screening visit. * Body mass index (BMI) ≥ 18.5 and ≤29.9 kg/m2 at the screening visit. * Continuous non-smoker who has not used nicotine- or tobacco-containing products for at least 3 months prior to first dosing. Exclusion Criteria: * Sustained supine systolic blood pressure ≥130 mmHg or \<90 mmHg, supine diastolic blood pressure ≥80 mmHg or \<50 mmHg at screening or first check-in. * History or presence of clinically significant ECG findings in the opinion of the Principal Investigator (PI) or designee at the screening visit or first check-in, including each of the following: * HR \<45 bpm or \>100 bpm. * QTcF is ≥450 msec (males) or ≥460 msec (females). * QRS ≥110 msec; if ≥110 msec, result will be confirmed by a manual over read. * PR ≥200 msec. * History or presence of: * Risk factors for Torsades de Pointes (e.g., heart failure, cardiomyopathy, family history of Long QT syndrome, Brugada syndrome, or sudden cardiac death). * Sick sinus syndrome, second- or third-degree atrioventricular block, myocardial infarction, angina, pulmonary congestion, symptomatic or significant cardiac arrhythmia, or clinically significant conduction abnormalities. * Clinically significant abnormal laboratory assessments including hypokalemia, hypercalcemia, or hypomagnesemia, in the opinion of the PI or designee.
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Ferring Investigational Site
Tempe, Arizona, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Carbetocin.
NCT IDStudyPhase / statusEnrollmentUpdated
The Efficacy of Carbitocin in Reduction of Blood Loss During Myomectomy
Alex Ekwueme Federal University Teaching Hospital · Blood Loss, Surgical
Early Phase 1
Not yet recruiting
900
2026-07
Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
Mansoura University · Postpartum Hemorrhage · Uterine Atony
Phase 4
Not yet recruiting
332
2026-06
Carbetocin Uterotonic Treatment in Twin Pregnancies for Prevention of Postpartum Hemorrhage
Sheba Medical Center · Postpartum Hemorrhage · Twin Pregnancy
Phase 4
Recruiting
120
2026-05
Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium
Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Postpartum Hemorrhage
Not applicable
Recruiting
32
2026-04
Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery
Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Post Partum Hemorrhage
Not applicable
Recruiting
160
2026-04
Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery
Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Postpartum Hemorrhage (Primary)
Not applicable
Recruiting
120
2026-04
Comparison of the Effect of Carbetocin Versus Oxytocin in the Prevention of Postpartum Hemorrhage After Emergency Caesarean Section in Antenatal Low-risk Patients
Ankara Etlik City Hospital · Postpartum Hemorrhage \(PPH\)
Not applicable
Completed
300
2026-02
Carbetocin Myocardium Trial 2014 Part 2
Oslo University Hospital · Pregnancy Complications
Phase 4
Completed
240
2026-02
Related PeptideStat pages
Put the record in context.
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