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
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