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Postpartum HemorrhagePhase 1NCT05924321

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

A Phase 1 study testing Carbetocin in people with Postpartum Hemorrhage, run by Ferring Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Postpartum Hemorrhage
What is being tested?
Carbetocin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
25 May 2023to 21 Sep 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ferring Investigational Site

    Tempe, Arizona, 85283

Other trials in United States

About this study

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

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.

Being tested
Carbetocin, Placebo, Placebo and Moxifloxacin
Medical subject headings
Postpartum Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarbetocinDrug

    Single infusion of Carbetocin

  • PlaceboDrug

    Single IV infusion of matching placebo

  • Placebo and MoxifloxacinDrug

    Single IV infusion of matching placebo in combination with Single Oral dose of Moxifloxacin

Study groups in NCT05924321
Study groupRoleWhat they receive
CarbetocinExperimentalSingle IV infusion of carbetocin
Receives: Drug: Carbetocin
PlaceboPlacebo comparatorSingle IV Infusion of matching placebo
Receives: Drug: Placebo
Placebo and MoxifloxacinActive comparatorSingle IV infusion of matching placebo with a single oral dose of moxifloxacin
Receives: Drug: Placebo and Moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Observed Heart rate(HR) values

    Part A

    Measured: Up to 240 minutes after Start of Infusion

  2. Change from baseline of HR (∆HR).

    Part A

    Measured: Up to 240 minutes after Start of Infusion

  3. 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).

    Part B

    Measured: Up to 24 hours after Start of Infusion

Secondary outcomes (84)

  1. Treatment-emergent adverse events (TEAEs)

    Part A

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  2. Vital signs; Systolic blood pressure and Diastolic blood pressure

    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.

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  3. Vital signs; Pulse rate

    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.

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  4. Vital signs; Body temperature

    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.

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  5. Vital signs; Respiratory rate

    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.

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  6. 12-lead safety ECGs

    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.

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  7. Clinical chemistry: Changes in Concentration of Blood Urea Nitrogen

    Part A. Assessed by blood sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  8. Clinical chemistry: Changes in Concentration of Bilirubin Total

    Part A. Assessed by blood sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  9. Clinical chemistry: Changes in Concentration of Bilirubin direct

    Part A. Assessed by blood sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  10. Clinical chemistry: Changes in Concentration of Alkaline phosphatase

    Part A. Assessed by blood sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  11. Clinical chemistry: Changes in Concentration of Aspartate aminotransferase

    Part A. Assessed by blood sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  12. Clinical chemistry: Changes in Concentration of Alanine aminotransferase

    Part A. Assessed by blood sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  13. Clinical chemistry: Changes in Concentration of Albumin

    Part A. Assessed by blood sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  14. Clinical chemistry: Changes in Concentration of Sodium

    Part A. Assessed by blood sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  15. Clinical chemistry: Changes in Concentration of Potassium

    Part A. Assessed by blood sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  16. Clinical chemistry: Changes in Concentration of Magnesium

    Part A. Assessed by blood sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  17. Clinical chemistry: Changes in Concentration of Chloride

    Part A. Assessed by blood sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  18. Clinical chemistry: Changes in Concentration of Fasting glucose

    Part A. Assessed by blood sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  19. Clinical chemistry: Changes in Concentration of Creatinine

    Part A. Assessed by blood sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  20. Hematology: Changes in Concentration of Hemoglobin

    Part A. Assessed by blood sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  21. Hematology: Changes in Concentration of Hematocrit

    Part A. Assessed by blood sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  22. Hematology: Changes in Concentration of Total and differential leukocyte count

    Part A. Assessed by blood sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  23. Hematology: Changes in Concentration of Red blood cell count

    Part A. Assessed by blood sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  24. Hematology: Changes in Concentration of Platelet count

    Part A. Assessed by blood sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  25. Urinalysis parameters: Concentration of pH

    Part A. Assessed by urine sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  26. Urinalysis parameters: Concentration of specific gravity

    Part A. Assessed by urine sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  27. Urinalysis parameters: Concentration of Protein

    Part A. Assessed by urine sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  28. Urinalysis parameters: Concentration of Glucose

    Part A. Assessed by urine sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  29. Urinalysis parameters: Concentration of Bilirubin

    Part A. Assessed by urine sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  30. Urinalysis parameters: Concentration of Blood

    Part A. Assessed by urine sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  31. Urinalysis parameters: Concentration of Nitrite

    Part A. Assessed by urine sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  32. Urinalysis parameters: Concentration of Urobilinogen

    Part A. Assessed by urine sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  33. Urinalysis parameters: Concentration of Leukocyte esterase

    Part A. Assessed by urine sample collection

    Measured: Up to follow-up visit (7 to 10 days after the last dose)

  34. ∆HR, PR change from baseline (∆PR), RR change from baseline (∆RR), QRS change from baseline (∆QRS), and QTcF change from baseline (∆QTcF), if not selected as the primary endpoint.

    Part B

    Measured: Up to 24 hours after Start of Infusion

  35. Placebo-corrected ∆HR (∆∆HR), placebo-corrected ∆PR (∆∆PR), placebo-corrected ∆RR (∆∆RR), placebo-corrected ∆QRS (∆∆QRS), and ∆∆QTcF, if not selected as the primary endpoint

    Part B

    Measured: Up to 24 hours after Start of Infusion

  36. Categorical outliers for QTcF

    Part B

    Measured: Up to 24 hours after Start of Infusion

  37. Categorical outliers for HR

    Part B

    Measured: Up to 24 hours after Start of Infusion

  38. Categorical outliers for PR

    Part B

    Measured: Up to 24 hours after Start of Infusion

  39. Categorical outliers for QRS

    Part B

    Measured: Up to 24 hours after Start of Infusion

  40. Abnormalities in T wave morphology and pathologic U waves, as appropriate.

    Part B

    Measured: Up to 24 hours after Start of Infusion

  41. Carbetocin PK parameters: AUClast

    Part B

    Measured: Up to 24 hours after Start of Infusion

  42. Carbetocin PK parameters: AUCinf

    Part B

    Measured: Up to 24 hours after Start of Infusion

  43. Carbetocin PK parameters: AUC%extrap

    Part B

    Measured: Up to 24 hours after Start of Infusion

  44. Carbetocin PK parameters: Cmax

    Part B

    Measured: Up to 24 hours after Start of Infusion

  45. Carbetocin PK parameters: Tmax

    Part B

    Measured: Up to 24 hours after Start of Infusion

  46. Carbetocin PK parameters: t½

    Part B

    Measured: Up to 24 hours after Start of Infusion

  47. Carbetocin PK parameters: MRTinf

    Part B

    Measured: Up to 24 hours after Start of Infusion

  48. Carbetocin PK parameters: CL

    Part B

    Measured: Up to 24 hours after Start of Infusion

  49. Carbetocin PK parameters: Vss

    Part B

    Measured: Up to 24 hours after Start of Infusion

  50. Carbetocin PK parameters: Vz.

    Part B

    Measured: Up to 24 hours after Start of Infusion

  51. ∆∆QTc (i.e., ∆∆QTcF or the most appropriate HR correction method) following administration of moxifloxacin.

    Part B

    Measured: Up to 24 hours after Start of Infusion

  52. TEAEs

    Part B

    Measured: End of Trial (Up to 25 days)

  53. Vital signs; Systolic blood pressure and Diastolic blood pressure

    Part B. 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

    Measured: End of Trial (Up to 25 days)

  54. Vital signs; Pulse rate

    Part B. The parameter which is measured is Pulse rate. The sign parameter value is classified as either Low, Normal or High

    Measured: End of Trial (Up to 25 days)

  55. Vital signs; Body temperature

    Part B. The parameter which is measured is Body temperature. The sign parameter value is classified as either Low, Normal or High

    Measured: End of Trial (Up to 25 days)

  56. Vital signs; Respiratory rate

    Part B. The parameter which is measured is Respiratory rate. The sign parameter value is classified as either Low, Normal or High

    Measured: End of Trial (Up to 25 days)

  57. 12-lead safety ECGs

    Part B. The parameters which are measured are QT, QTc, QTcF, QRS, PR, RR and HR. The results will be interpreted as "normal", "abnormal, not clinically significant" or "abnormal clinically significant".

    Measured: End of Trial (Up to 25 days)

  58. Clinical chemistry: Changes in Concentration of Blood Urea Nitrogen

    Part B. Assessed by blood sample collection

    Measured: End of Trial (Up to 25 days)

  59. Clinical chemistry: Changes in Concentration of Bilirubin total

    Part B. Assessed by blood sample collection

    Measured: End of Trial (Up to 25 days)

  60. Clinical chemistry: Changes in Concentration of Bilirubin direct

    Part B. Assessed by blood sample collection

    Measured: End of Trial (Up to 25 days)

  61. Clinical chemistry: Changes in Concentration of Alkaline phosphatase

    Part B. Assessed by blood sample collection

    Measured: End of Trial (Up to 25 days)

  62. Clinical chemistry: Changes in Concentration of Aspartate aminotransferase

    Part B. Assessed by blood sample collection

    Measured: End of Trial (Up to 25 days)

  63. Clinical chemistry: Changes in Concentration of Alanine aminotransferase

    Part B. Assessed by blood sample collection

    Measured: End of Trial (Up to 25 days)

  64. Clinical chemistry: Changes in Concentration of Albumin

    Part B. Assessed by blood sample collection

    Measured: End of Trial (Up to 25 days)

  65. Clinical chemistry: Changes in Concentration of Sodium

    Part B. Assessed by blood sample collection

    Measured: End of Trial (Up to 25 days)

  66. Clinical chemistry: Changes in Concentration of Potassium

    Part B. Assessed by blood sample collection

    Measured: End of Trial (Up to 25 days)

  67. Clinical chemistry: Changes in Concentration of Magnesium

    Part B. Assessed by blood sample collection

    Measured: End of Trial (Up to 25 days)

  68. Clinical chemistry: Changes in Concentration of Chloride

    Part B. Assessed by blood sample collection

    Measured: End of Trial (Up to 25 days)

  69. Clinical chemistry: Changes in Concentration of Fasting glucose

    Part B. Assessed by blood sample collection

    Measured: End of Trial (Up to 25 days)

  70. Clinical chemistry: Changes in Concentration of Creatinine

    Part B. Assessed by blood sample collection

    Measured: End of Trial (Up to 25 days)

  71. Hematology: Changes in Concentration of Hemoglobin

    Part B. Assessed by blood sample collection

    Measured: End of Trial (Up to 25 days)

  72. Hematology: Changes in Concentration of Hematocrit

    Part B. Assessed by blood sample collection

    Measured: End of Trial (Up to 25 days)

  73. Hematology: Changes in Concentration of Total and Differential leukocyte count

    Part B. Assessed by blood sample collection

    Measured: End of Trial (Up to 25 days)

  74. Hematology: Changes in Concentration of Red blood cell count

    Part B. Assessed by blood sample collection

    Measured: End of Trial (Up to 25 days)

  75. Hematology: Changes in Concentration of Platelet count

    Part B. Assessed by blood sample collection

    Measured: End of Trial (Up to 25 days)

  76. Urinalysis parameters: Concentration of pH

    Part B. Assessed by urine sample collection

    Measured: End of Trial (Up to 25 days)

  77. Urinalysis parameters: Concentration of Specific gravity

    Part B. Assessed by urine sample collection

    Measured: End of Trial (Up to 25 days)

  78. Urinalysis parameters: Concentration of Protein

    Part B. Assessed by urine sample collection

    Measured: End of Trial (Up to 25 days)

  79. Urinalysis parameters: Concentration of Glucose

    Part B. Assessed by urine sample collection

    Measured: End of Trial (Up to 25 days)

  80. Urinalysis parameters: Concentration of Bilirubin

    Part B. Assessed by urine sample collection

    Measured: End of Trial (Up to 25 days)

  81. Urinalysis parameters: Concentration of Blood

    Part B. Assessed by urine sample collection

    Measured: End of Trial (Up to 25 days)

  82. Urinalysis parameters: Concentration of Nitrite

    Part B. Assessed by urine sample collection

    Measured: End of Trial (Up to 25 days)

  83. Urinalysis parameters: Concentration of Urobilinogen

    Part B. Assessed by urine sample collection

    Measured: End of Trial (Up to 25 days)

  84. Urinalysis parameters: Concentration of Leukocyte esterase

    Part B. Assessed by urine sample collection

    Measured: End of Trial (Up to 25 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2023
  2. Study start25 May 2023
  3. Primary completion21 Sep 2023
  4. Study completion21 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05924321
Sponsor's protocol ID
000421
Status last verified
May 2023
First submitted
3 May 2023
Last updated
3 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jonker DM, Barletta K, Bagci E, Raymond K, Pinton P. The Effect of Carbetocin on Cardiac Repolarization: A Randomized, Placebo- and Positive-Controlled QT/QTc Study in Healthy Adults. Clin Transl Sci. 2026 Oct;19(10):e70735. doi: 10.1111/cts.70735.

    PubMed 42802704

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Carbetocin in people with Postpartum Hemorrhage, run by Ferring Pharmaceuticals at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Observed Heart rate(HR) values (time frame: Up to 240 minutes after Start of Infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05924321, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.

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