A Study to Evaluate the Effect of Carbetocin on the QT/QTc Interval in Healthy Subjects
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| ClinicalTrials.gov Identifier: NCT05924321 |
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Recruitment Status :
Completed
First Posted : June 29, 2023
Last Update Posted : September 26, 2023
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Sponsor:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Ferring Pharmaceuticals
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Postpartum Hemorrhage | Drug: Carbetocin Drug: Placebo Drug: Placebo and Moxifloxacin | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | The trial will consist of two parts; Part A and Part B. Part A is an open-label single group trial while Part B is a double-blind trial with 3 groups. |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, 2-Part, Crossover Trial to Evaluate the Effect of Carbetocin on the QT/QTc Interval in Healthy Subjects |
| Actual Study Start Date : | May 25, 2023 |
| Actual Primary Completion Date : | September 21, 2023 |
| Actual Study Completion Date : | September 21, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Bleeding
Drug Information
available for:
Moxifloxacin
| Arm | Intervention/treatment |
|---|---|
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Experimental: Carbetocin
Single IV infusion of carbetocin
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Drug: Carbetocin
Single infusion of Carbetocin |
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Placebo Comparator: Placebo
Single IV Infusion of matching placebo
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Drug: Placebo
Single IV infusion of matching placebo |
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Active Comparator: Placebo and Moxifloxacin
Single IV infusion of matching placebo with a single oral dose of moxifloxacin
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Drug: Placebo and Moxifloxacin
Single IV infusion of matching placebo in combination with Single Oral dose of Moxifloxacin |
Primary Outcome Measures :
- 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 Outcome Measures :
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- ∆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
- 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
- Categorical outliers for QTcF [ Time Frame: Up to 24 hours after Start of Infusion ]Part B
- Categorical outliers for HR [ Time Frame: Up to 24 hours after Start of Infusion ]Part B
- Categorical outliers for PR [ Time Frame: Up to 24 hours after Start of Infusion ]Part B
- Categorical outliers for QRS [ Time Frame: Up to 24 hours after Start of Infusion ]Part B
- Abnormalities in T wave morphology and pathologic U waves, as appropriate. [ Time Frame: Up to 24 hours after Start of Infusion ]Part B
- Carbetocin PK parameters: AUClast [ Time Frame: Up to 24 hours after Start of Infusion ]Part B
- Carbetocin PK parameters: AUCinf [ Time Frame: Up to 24 hours after Start of Infusion ]Part B
- Carbetocin PK parameters: AUC%extrap [ Time Frame: Up to 24 hours after Start of Infusion ]Part B
- Carbetocin PK parameters: Cmax [ Time Frame: Up to 24 hours after Start of Infusion ]Part B
- Carbetocin PK parameters: Tmax [ Time Frame: Up to 24 hours after Start of Infusion ]Part B
- Carbetocin PK parameters: t½ [ Time Frame: Up to 24 hours after Start of Infusion ]Part B
- Carbetocin PK parameters: MRTinf [ Time Frame: Up to 24 hours after Start of Infusion ]Part B
- Carbetocin PK parameters: CL [ Time Frame: Up to 24 hours after Start of Infusion ]Part B
- Carbetocin PK parameters: Vss [ Time Frame: Up to 24 hours after Start of Infusion ]Part B
- Carbetocin PK parameters: Vz. [ Time Frame: Up to 24 hours after Start of Infusion ]Part B
- ∆∆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
- TEAEs [ Time Frame: End of Trial (Up to 25 days) ]Part B
- 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
- 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
- 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
- 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
- 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".
- 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
- Clinical chemistry: Changes in Concentration of Bilirubin total [ Time Frame: End of Trial (Up to 25 days) ]Part B. Assessed by blood sample collection
- Clinical chemistry: Changes in Concentration of Bilirubin direct [ Time Frame: End of Trial (Up to 25 days) ]Part B. Assessed by blood sample collection
- Clinical chemistry: Changes in Concentration of Alkaline phosphatase [ Time Frame: End of Trial (Up to 25 days) ]Part B. Assessed by blood sample collection
- Clinical chemistry: Changes in Concentration of Aspartate aminotransferase [ Time Frame: End of Trial (Up to 25 days) ]Part B. Assessed by blood sample collection
- Clinical chemistry: Changes in Concentration of Alanine aminotransferase [ Time Frame: End of Trial (Up to 25 days) ]Part B. Assessed by blood sample collection
- Clinical chemistry: Changes in Concentration of Albumin [ Time Frame: End of Trial (Up to 25 days) ]Part B. Assessed by blood sample collection
- Clinical chemistry: Changes in Concentration of Sodium [ Time Frame: End of Trial (Up to 25 days) ]Part B. Assessed by blood sample collection
- Clinical chemistry: Changes in Concentration of Potassium [ Time Frame: End of Trial (Up to 25 days) ]Part B. Assessed by blood sample collection
- Clinical chemistry: Changes in Concentration of Magnesium [ Time Frame: End of Trial (Up to 25 days) ]Part B. Assessed by blood sample collection
- Clinical chemistry: Changes in Concentration of Chloride [ Time Frame: End of Trial (Up to 25 days) ]Part B. Assessed by blood sample collection
- Clinical chemistry: Changes in Concentration of Fasting glucose [ Time Frame: End of Trial (Up to 25 days) ]Part B. Assessed by blood sample collection
- Clinical chemistry: Changes in Concentration of Creatinine [ Time Frame: End of Trial (Up to 25 days) ]Part B. Assessed by blood sample collection
- Hematology: Changes in Concentration of Hemoglobin [ Time Frame: End of Trial (Up to 25 days) ]Part B. Assessed by blood sample collection
- Hematology: Changes in Concentration of Hematocrit [ Time Frame: End of Trial (Up to 25 days) ]Part B. Assessed by blood sample collection
- 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
- 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
- Hematology: Changes in Concentration of Platelet count [ Time Frame: End of Trial (Up to 25 days) ]Part B. Assessed by blood sample collection
- Urinalysis parameters: Concentration of pH [ Time Frame: End of Trial (Up to 25 days) ]Part B. Assessed by urine sample collection
- Urinalysis parameters: Concentration of Specific gravity [ Time Frame: End of Trial (Up to 25 days) ]Part B. Assessed by urine sample collection
- Urinalysis parameters: Concentration of Protein [ Time Frame: End of Trial (Up to 25 days) ]Part B. Assessed by urine sample collection
- Urinalysis parameters: Concentration of Glucose [ Time Frame: End of Trial (Up to 25 days) ]Part B. Assessed by urine sample collection
- Urinalysis parameters: Concentration of Bilirubin [ Time Frame: End of Trial (Up to 25 days) ]Part B. Assessed by urine sample collection
- Urinalysis parameters: Concentration of Blood [ Time Frame: End of Trial (Up to 25 days) ]Part B. Assessed by urine sample collection
- Urinalysis parameters: Concentration of Nitrite [ Time Frame: End of Trial (Up to 25 days) ]Part B. Assessed by urine sample collection
- Urinalysis parameters: Concentration of Urobilinogen [ Time Frame: End of Trial (Up to 25 days) ]Part B. Assessed by urine sample collection
- Urinalysis parameters: Concentration of Leukocyte esterase [ Time Frame: End of Trial (Up to 25 days) ]Part B. Assessed by urine sample collection
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
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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.
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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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05924321
Locations
| United States, Arizona | |
| Ferring Investigational Site | |
| Tempe, Arizona, United States, 85283 | |
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
| Study Director: | Global Clinical Compliance | Ferring Pharmaceuticals |
| Responsible Party: | Ferring Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT05924321 |
| Other Study ID Numbers: |
000421 |
| First Posted: | June 29, 2023 Key Record Dates |
| Last Update Posted: | September 26, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Postpartum Hemorrhage Hemorrhage Pathologic Processes Obstetric Labor Complications Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Puerperal Disorders Uterine Hemorrhage Moxifloxacin Carbetocin |
Anti-Bacterial Agents Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Reproductive Control Agents Physiological Effects of Drugs Oxytocics |