search
Back to results

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

Primary Purpose

Postpartum Hemorrhage

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Carbetocin
Placebo
Placebo and Moxifloxacin
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Hemorrhage

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ferring Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Carbetocin

Placebo

Placebo and Moxifloxacin

Arm Description

Single IV infusion of carbetocin

Single IV Infusion of matching placebo

Single IV infusion of matching placebo with a single oral dose of moxifloxacin

Outcomes

Primary Outcome Measures

Observed Heart rate(HR) values
Part A
Change from baseline of HR (∆HR).
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).
Part B

Secondary Outcome Measures

Treatment-emergent adverse events (TEAEs)
Part A
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.
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.
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.
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.
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.
Clinical chemistry: Changes in Concentration of Blood Urea Nitrogen
Part A. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Bilirubin Total
Part A. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Bilirubin direct
Part A. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Alkaline phosphatase
Part A. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Aspartate aminotransferase
Part A. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Alanine aminotransferase
Part A. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Albumin
Part A. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Sodium
Part A. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Potassium
Part A. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Magnesium
Part A. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Chloride
Part A. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Fasting glucose
Part A. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Creatinine
Part A. Assessed by blood sample collection
Hematology: Changes in Concentration of Hemoglobin
Part A. Assessed by blood sample collection
Hematology: Changes in Concentration of Hematocrit
Part A. Assessed by blood sample collection
Hematology: Changes in Concentration of Total and differential leukocyte count
Part A. Assessed by blood sample collection
Hematology: Changes in Concentration of Red blood cell count
Part A. Assessed by blood sample collection
Hematology: Changes in Concentration of Platelet count
Part A. Assessed by blood sample collection
Urinalysis parameters: Concentration of pH
Part A. Assessed by urine sample collection
Urinalysis parameters: Concentration of specific gravity
Part A. Assessed by urine sample collection
Urinalysis parameters: Concentration of Protein
Part A. Assessed by urine sample collection
Urinalysis parameters: Concentration of Glucose
Part A. Assessed by urine sample collection
Urinalysis parameters: Concentration of Bilirubin
Part A. Assessed by urine sample collection
Urinalysis parameters: Concentration of Blood
Part A. Assessed by urine sample collection
Urinalysis parameters: Concentration of Nitrite
Part A. Assessed by urine sample collection
Urinalysis parameters: Concentration of Urobilinogen
Part A. Assessed by urine sample collection
Urinalysis parameters: Concentration of Leukocyte esterase
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.
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
Part B
Categorical outliers for QTcF
Part B
Categorical outliers for HR
Part B
Categorical outliers for PR
Part B
Categorical outliers for QRS
Part B
Abnormalities in T wave morphology and pathologic U waves, as appropriate.
Part B
Carbetocin PK parameters: AUClast
Part B
Carbetocin PK parameters: AUCinf
Part B
Carbetocin PK parameters: AUC%extrap
Part B
Carbetocin PK parameters: Cmax
Part B
Carbetocin PK parameters: Tmax
Part B
Carbetocin PK parameters: t½
Part B
Carbetocin PK parameters: MRTinf
Part B
Carbetocin PK parameters: CL
Part B
Carbetocin PK parameters: Vss
Part B
Carbetocin PK parameters: Vz.
Part B
∆∆QTc (i.e., ∆∆QTcF or the most appropriate HR correction method) following administration of moxifloxacin.
Part B
TEAEs
Part B
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
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
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
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
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".
Clinical chemistry: Changes in Concentration of Blood Urea Nitrogen
Part B. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Bilirubin total
Part B. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Bilirubin direct
Part B. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Alkaline phosphatase
Part B. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Aspartate aminotransferase
Part B. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Alanine aminotransferase
Part B. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Albumin
Part B. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Sodium
Part B. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Potassium
Part B. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Magnesium
Part B. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Chloride
Part B. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Fasting glucose
Part B. Assessed by blood sample collection
Clinical chemistry: Changes in Concentration of Creatinine
Part B. Assessed by blood sample collection
Hematology: Changes in Concentration of Hemoglobin
Part B. Assessed by blood sample collection
Hematology: Changes in Concentration of Hematocrit
Part B. Assessed by blood sample collection
Hematology: Changes in Concentration of Total and Differential leukocyte count
Part B. Assessed by blood sample collection
Hematology: Changes in Concentration of Red blood cell count
Part B. Assessed by blood sample collection
Hematology: Changes in Concentration of Platelet count
Part B. Assessed by blood sample collection
Urinalysis parameters: Concentration of pH
Part B. Assessed by urine sample collection
Urinalysis parameters: Concentration of Specific gravity
Part B. Assessed by urine sample collection
Urinalysis parameters: Concentration of Protein
Part B. Assessed by urine sample collection
Urinalysis parameters: Concentration of Glucose
Part B. Assessed by urine sample collection
Urinalysis parameters: Concentration of Bilirubin
Part B. Assessed by urine sample collection
Urinalysis parameters: Concentration of Blood
Part B. Assessed by urine sample collection
Urinalysis parameters: Concentration of Nitrite
Part B. Assessed by urine sample collection
Urinalysis parameters: Concentration of Urobilinogen
Part B. Assessed by urine sample collection
Urinalysis parameters: Concentration of Leukocyte esterase
Part B. Assessed by urine sample collection

Full Information

First Posted
May 3, 2023
Last Updated
September 25, 2023
Sponsor
Ferring Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT05924321
Brief Title
A Study to Evaluate the Effect of Carbetocin on the QT/QTc Interval in Healthy Subjects
Official Title
A Randomized, 2-Part, Crossover Trial to Evaluate the Effect of Carbetocin on the QT/QTc Interval in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 25, 2023 (Actual)
Primary Completion Date
September 21, 2023 (Actual)
Study Completion Date
September 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carbetocin
Arm Type
Experimental
Arm Description
Single IV infusion of carbetocin
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single IV Infusion of matching placebo
Arm Title
Placebo and Moxifloxacin
Arm Type
Active Comparator
Arm Description
Single IV infusion of matching placebo with a single oral dose of moxifloxacin
Intervention Type
Drug
Intervention Name(s)
Carbetocin
Intervention Description
Single infusion of Carbetocin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single IV infusion of matching placebo
Intervention Type
Drug
Intervention Name(s)
Placebo and Moxifloxacin
Intervention Description
Single IV infusion of matching placebo in combination with Single Oral dose of Moxifloxacin
Primary Outcome Measure Information:
Title
Observed Heart rate(HR) values
Description
Part A
Time Frame
Up to 240 minutes after Start of Infusion
Title
Change from baseline of HR (∆HR).
Description
Part A
Time Frame
Up to 240 minutes after Start of Infusion
Title
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).
Description
Part B
Time Frame
Up to 24 hours after Start of Infusion
Secondary Outcome Measure Information:
Title
Treatment-emergent adverse events (TEAEs)
Description
Part A
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Vital signs; Systolic blood pressure and Diastolic blood pressure
Description
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.
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Vital signs; Pulse rate
Description
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.
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Vital signs; Body temperature
Description
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.
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Vital signs; Respiratory rate
Description
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.
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
12-lead safety ECGs
Description
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.
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Clinical chemistry: Changes in Concentration of Blood Urea Nitrogen
Description
Part A. Assessed by blood sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Clinical chemistry: Changes in Concentration of Bilirubin Total
Description
Part A. Assessed by blood sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Clinical chemistry: Changes in Concentration of Bilirubin direct
Description
Part A. Assessed by blood sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Clinical chemistry: Changes in Concentration of Alkaline phosphatase
Description
Part A. Assessed by blood sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Clinical chemistry: Changes in Concentration of Aspartate aminotransferase
Description
Part A. Assessed by blood sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Clinical chemistry: Changes in Concentration of Alanine aminotransferase
Description
Part A. Assessed by blood sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Clinical chemistry: Changes in Concentration of Albumin
Description
Part A. Assessed by blood sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Clinical chemistry: Changes in Concentration of Sodium
Description
Part A. Assessed by blood sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Clinical chemistry: Changes in Concentration of Potassium
Description
Part A. Assessed by blood sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Clinical chemistry: Changes in Concentration of Magnesium
Description
Part A. Assessed by blood sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Clinical chemistry: Changes in Concentration of Chloride
Description
Part A. Assessed by blood sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Clinical chemistry: Changes in Concentration of Fasting glucose
Description
Part A. Assessed by blood sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Clinical chemistry: Changes in Concentration of Creatinine
Description
Part A. Assessed by blood sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Hematology: Changes in Concentration of Hemoglobin
Description
Part A. Assessed by blood sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Hematology: Changes in Concentration of Hematocrit
Description
Part A. Assessed by blood sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Hematology: Changes in Concentration of Total and differential leukocyte count
Description
Part A. Assessed by blood sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Hematology: Changes in Concentration of Red blood cell count
Description
Part A. Assessed by blood sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Hematology: Changes in Concentration of Platelet count
Description
Part A. Assessed by blood sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Urinalysis parameters: Concentration of pH
Description
Part A. Assessed by urine sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Urinalysis parameters: Concentration of specific gravity
Description
Part A. Assessed by urine sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Urinalysis parameters: Concentration of Protein
Description
Part A. Assessed by urine sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Urinalysis parameters: Concentration of Glucose
Description
Part A. Assessed by urine sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Urinalysis parameters: Concentration of Bilirubin
Description
Part A. Assessed by urine sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Urinalysis parameters: Concentration of Blood
Description
Part A. Assessed by urine sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Urinalysis parameters: Concentration of Nitrite
Description
Part A. Assessed by urine sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Urinalysis parameters: Concentration of Urobilinogen
Description
Part A. Assessed by urine sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
Urinalysis parameters: Concentration of Leukocyte esterase
Description
Part A. Assessed by urine sample collection
Time Frame
Up to follow-up visit (7 to 10 days after the last dose)
Title
∆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.
Description
Part B
Time Frame
Up to 24 hours after Start of Infusion
Title
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
Description
Part B
Time Frame
Up to 24 hours after Start of Infusion
Title
Categorical outliers for QTcF
Description
Part B
Time Frame
Up to 24 hours after Start of Infusion
Title
Categorical outliers for HR
Description
Part B
Time Frame
Up to 24 hours after Start of Infusion
Title
Categorical outliers for PR
Description
Part B
Time Frame
Up to 24 hours after Start of Infusion
Title
Categorical outliers for QRS
Description
Part B
Time Frame
Up to 24 hours after Start of Infusion
Title
Abnormalities in T wave morphology and pathologic U waves, as appropriate.
Description
Part B
Time Frame
Up to 24 hours after Start of Infusion
Title
Carbetocin PK parameters: AUClast
Description
Part B
Time Frame
Up to 24 hours after Start of Infusion
Title
Carbetocin PK parameters: AUCinf
Description
Part B
Time Frame
Up to 24 hours after Start of Infusion
Title
Carbetocin PK parameters: AUC%extrap
Description
Part B
Time Frame
Up to 24 hours after Start of Infusion
Title
Carbetocin PK parameters: Cmax
Description
Part B
Time Frame
Up to 24 hours after Start of Infusion
Title
Carbetocin PK parameters: Tmax
Description
Part B
Time Frame
Up to 24 hours after Start of Infusion
Title
Carbetocin PK parameters: t½
Description
Part B
Time Frame
Up to 24 hours after Start of Infusion
Title
Carbetocin PK parameters: MRTinf
Description
Part B
Time Frame
Up to 24 hours after Start of Infusion
Title
Carbetocin PK parameters: CL
Description
Part B
Time Frame
Up to 24 hours after Start of Infusion
Title
Carbetocin PK parameters: Vss
Description
Part B
Time Frame
Up to 24 hours after Start of Infusion
Title
Carbetocin PK parameters: Vz.
Description
Part B
Time Frame
Up to 24 hours after Start of Infusion
Title
∆∆QTc (i.e., ∆∆QTcF or the most appropriate HR correction method) following administration of moxifloxacin.
Description
Part B
Time Frame
Up to 24 hours after Start of Infusion
Title
TEAEs
Description
Part B
Time Frame
End of Trial (Up to 25 days)
Title
Vital signs; Systolic blood pressure and Diastolic blood pressure
Description
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
Time Frame
End of Trial (Up to 25 days)
Title
Vital signs; Pulse rate
Description
Part B. The parameter which is measured is Pulse rate. The sign parameter value is classified as either Low, Normal or High
Time Frame
End of Trial (Up to 25 days)
Title
Vital signs; Body temperature
Description
Part B. The parameter which is measured is Body temperature. The sign parameter value is classified as either Low, Normal or High
Time Frame
End of Trial (Up to 25 days)
Title
Vital signs; Respiratory rate
Description
Part B. The parameter which is measured is Respiratory rate. The sign parameter value is classified as either Low, Normal or High
Time Frame
End of Trial (Up to 25 days)
Title
12-lead safety ECGs
Description
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".
Time Frame
End of Trial (Up to 25 days)
Title
Clinical chemistry: Changes in Concentration of Blood Urea Nitrogen
Description
Part B. Assessed by blood sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Clinical chemistry: Changes in Concentration of Bilirubin total
Description
Part B. Assessed by blood sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Clinical chemistry: Changes in Concentration of Bilirubin direct
Description
Part B. Assessed by blood sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Clinical chemistry: Changes in Concentration of Alkaline phosphatase
Description
Part B. Assessed by blood sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Clinical chemistry: Changes in Concentration of Aspartate aminotransferase
Description
Part B. Assessed by blood sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Clinical chemistry: Changes in Concentration of Alanine aminotransferase
Description
Part B. Assessed by blood sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Clinical chemistry: Changes in Concentration of Albumin
Description
Part B. Assessed by blood sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Clinical chemistry: Changes in Concentration of Sodium
Description
Part B. Assessed by blood sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Clinical chemistry: Changes in Concentration of Potassium
Description
Part B. Assessed by blood sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Clinical chemistry: Changes in Concentration of Magnesium
Description
Part B. Assessed by blood sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Clinical chemistry: Changes in Concentration of Chloride
Description
Part B. Assessed by blood sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Clinical chemistry: Changes in Concentration of Fasting glucose
Description
Part B. Assessed by blood sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Clinical chemistry: Changes in Concentration of Creatinine
Description
Part B. Assessed by blood sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Hematology: Changes in Concentration of Hemoglobin
Description
Part B. Assessed by blood sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Hematology: Changes in Concentration of Hematocrit
Description
Part B. Assessed by blood sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Hematology: Changes in Concentration of Total and Differential leukocyte count
Description
Part B. Assessed by blood sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Hematology: Changes in Concentration of Red blood cell count
Description
Part B. Assessed by blood sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Hematology: Changes in Concentration of Platelet count
Description
Part B. Assessed by blood sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Urinalysis parameters: Concentration of pH
Description
Part B. Assessed by urine sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Urinalysis parameters: Concentration of Specific gravity
Description
Part B. Assessed by urine sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Urinalysis parameters: Concentration of Protein
Description
Part B. Assessed by urine sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Urinalysis parameters: Concentration of Glucose
Description
Part B. Assessed by urine sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Urinalysis parameters: Concentration of Bilirubin
Description
Part B. Assessed by urine sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Urinalysis parameters: Concentration of Blood
Description
Part B. Assessed by urine sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Urinalysis parameters: Concentration of Nitrite
Description
Part B. Assessed by urine sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Urinalysis parameters: Concentration of Urobilinogen
Description
Part B. Assessed by urine sample collection
Time Frame
End of Trial (Up to 25 days)
Title
Urinalysis parameters: Concentration of Leukocyte esterase
Description
Part B. Assessed by urine sample collection
Time Frame
End of Trial (Up to 25 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Compliance
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Ferring Investigational Site
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs