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Completed

NCT Number: NCT05924321

A Study 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.

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Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ferring Investigational Site

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carbetocin

Drug

Single infusion of Carbetocin

Placebo

Drug

Single IV infusion of matching placebo

Placebo and Moxifloxacin

Drug

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

Primary outcomes

  1. Observed Heart rate(HR) values

    Time frame: Up to 240 minutes after Start of Infusion

    Part A

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

    Time frame: Up to 240 minutes after Start of Infusion

    Part A

  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).

    Time frame: Up to 24 hours after Start of Infusion

    Part B

Secondary outcomes

  1. Treatment-emergent adverse events (TEAEs)

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

    Part A

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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

  11. Clinical chemistry: Changes in Concentration of Aspartate aminotransferase

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

    Part A. Assessed by blood sample collection

  12. Clinical chemistry: Changes in Concentration of Alanine aminotransferase

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

    Part A. Assessed by blood sample collection

  13. Clinical chemistry: Changes in Concentration of Albumin

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

    Part A. Assessed by blood sample collection

  14. Clinical chemistry: Changes in Concentration of Sodium

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

    Part A. Assessed by blood sample collection

  15. Clinical chemistry: Changes in Concentration of Potassium

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

    Part A. Assessed by blood sample collection

  16. Clinical chemistry: Changes in Concentration of Magnesium

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

    Part A. Assessed by blood sample collection

  17. Clinical chemistry: Changes in Concentration of Chloride

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

    Part A. Assessed by blood sample collection

  18. Clinical chemistry: Changes in Concentration of Fasting glucose

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

    Part A. Assessed by blood sample collection

  19. Clinical chemistry: Changes in Concentration of Creatinine

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

    Part A. Assessed by blood sample collection

  20. Hematology: Changes in Concentration of Hemoglobin

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

    Part A. Assessed by blood sample collection

  21. Hematology: Changes in Concentration of Hematocrit

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

    Part A. Assessed by blood sample collection

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

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

    Part A. Assessed by blood sample collection

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

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

    Part A. Assessed by blood sample collection

  24. Hematology: Changes in Concentration of Platelet count

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

    Part A. Assessed by blood sample collection

  25. Urinalysis parameters: Concentration of pH

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

    Part A. Assessed by urine sample collection

  26. Urinalysis parameters: Concentration of specific gravity

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

    Part A. Assessed by urine sample collection

  27. Urinalysis parameters: Concentration of Protein

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

    Part A. Assessed by urine sample collection

  28. Urinalysis parameters: Concentration of Glucose

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

    Part A. Assessed by urine sample collection

  29. Urinalysis parameters: Concentration of Bilirubin

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

    Part A. Assessed by urine sample collection

  30. Urinalysis parameters: Concentration of Blood

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

    Part A. Assessed by urine sample collection

  31. Urinalysis parameters: Concentration of Nitrite

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

    Part A. Assessed by urine sample collection

  32. Urinalysis parameters: Concentration of Urobilinogen

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

    Part A. Assessed by urine sample collection

  33. Urinalysis parameters: Concentration of Leukocyte esterase

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

    Part A. Assessed by urine sample collection

  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.

    Time frame: Up to 24 hours after Start of Infusion

    Part B

  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

    Time frame: Up to 24 hours after Start of Infusion

    Part B

  36. Categorical outliers for QTcF

    Time frame: Up to 24 hours after Start of Infusion

    Part B

  37. Categorical outliers for HR

    Time frame: Up to 24 hours after Start of Infusion

    Part B

  38. Categorical outliers for PR

    Time frame: Up to 24 hours after Start of Infusion

    Part B

  39. Categorical outliers for QRS

    Time frame: Up to 24 hours after Start of Infusion

    Part B

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

    Time frame: Up to 24 hours after Start of Infusion

    Part B

  41. Carbetocin PK parameters: AUClast

    Time frame: Up to 24 hours after Start of Infusion

    Part B

  42. Carbetocin PK parameters: AUCinf

    Time frame: Up to 24 hours after Start of Infusion

    Part B

  43. Carbetocin PK parameters: AUC%extrap

    Time frame: Up to 24 hours after Start of Infusion

    Part B

  44. Carbetocin PK parameters: Cmax

    Time frame: Up to 24 hours after Start of Infusion

    Part B

  45. Carbetocin PK parameters: Tmax

    Time frame: Up to 24 hours after Start of Infusion

    Part B

  46. Carbetocin PK parameters: t½

    Time frame: Up to 24 hours after Start of Infusion

    Part B

  47. Carbetocin PK parameters: MRTinf

    Time frame: Up to 24 hours after Start of Infusion

    Part B

  48. Carbetocin PK parameters: CL

    Time frame: Up to 24 hours after Start of Infusion

    Part B

  49. Carbetocin PK parameters: Vss

    Time frame: Up to 24 hours after Start of Infusion

    Part B

  50. Carbetocin PK parameters: Vz.

    Time frame: Up to 24 hours after Start of Infusion

    Part B

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

    Time frame: Up to 24 hours after Start of Infusion

    Part B

  52. TEAEs

    Time frame: End of Trial (Up to 25 days)

    Part B

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

    Time frame: End of Trial (Up to 25 days)

    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

  54. Vital signs; Pulse rate

    Time frame: End of Trial (Up to 25 days)

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

  55. Vital signs; Body temperature

    Time frame: End of Trial (Up to 25 days)

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

  56. Vital signs; Respiratory rate

    Time frame: End of Trial (Up to 25 days)

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

  57. 12-lead safety ECGs

    Time frame: End of Trial (Up to 25 days)

    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".

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

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by blood sample collection

  59. Clinical chemistry: Changes in Concentration of Bilirubin total

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by blood sample collection

  60. Clinical chemistry: Changes in Concentration of Bilirubin direct

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by blood sample collection

  61. Clinical chemistry: Changes in Concentration of Alkaline phosphatase

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by blood sample collection

  62. Clinical chemistry: Changes in Concentration of Aspartate aminotransferase

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by blood sample collection

  63. Clinical chemistry: Changes in Concentration of Alanine aminotransferase

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by blood sample collection

  64. Clinical chemistry: Changes in Concentration of Albumin

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by blood sample collection

  65. Clinical chemistry: Changes in Concentration of Sodium

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by blood sample collection

  66. Clinical chemistry: Changes in Concentration of Potassium

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by blood sample collection

  67. Clinical chemistry: Changes in Concentration of Magnesium

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by blood sample collection

  68. Clinical chemistry: Changes in Concentration of Chloride

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by blood sample collection

  69. Clinical chemistry: Changes in Concentration of Fasting glucose

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by blood sample collection

  70. Clinical chemistry: Changes in Concentration of Creatinine

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by blood sample collection

  71. Hematology: Changes in Concentration of Hemoglobin

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by blood sample collection

  72. Hematology: Changes in Concentration of Hematocrit

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by blood sample collection

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

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by blood sample collection

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

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by blood sample collection

  75. Hematology: Changes in Concentration of Platelet count

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by blood sample collection

  76. Urinalysis parameters: Concentration of pH

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by urine sample collection

  77. Urinalysis parameters: Concentration of Specific gravity

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by urine sample collection

  78. Urinalysis parameters: Concentration of Protein

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by urine sample collection

  79. Urinalysis parameters: Concentration of Glucose

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by urine sample collection

  80. Urinalysis parameters: Concentration of Bilirubin

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by urine sample collection

  81. Urinalysis parameters: Concentration of Blood

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by urine sample collection

  82. Urinalysis parameters: Concentration of Nitrite

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by urine sample collection

  83. Urinalysis parameters: Concentration of Urobilinogen

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by urine sample collection

  84. Urinalysis parameters: Concentration of Leukocyte esterase

    Time frame: End of Trial (Up to 25 days)

    Part B. Assessed by urine sample collection

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 29, 2023
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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