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

Treatment-emergent adverse events (TEAEs)

Part A

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

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.

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

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.

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

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.

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

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.

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

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.

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

Clinical chemistry: Changes in Concentration of Blood Urea Nitrogen

Part A. Assessed by blood sample collection

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

Clinical chemistry: Changes in Concentration of Bilirubin Total

Part A. Assessed by blood sample collection

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

Clinical chemistry: Changes in Concentration of Bilirubin direct

Part A. Assessed by blood sample collection

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

Clinical chemistry: Changes in Concentration of Alkaline phosphatase

Part A. Assessed by blood sample collection

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

Clinical chemistry: Changes in Concentration of Aspartate aminotransferase

Part A. Assessed by blood sample collection

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

Clinical chemistry: Changes in Concentration of Alanine aminotransferase

Part A. Assessed by blood sample collection

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

Clinical chemistry: Changes in Concentration of Albumin

Part A. Assessed by blood sample collection

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

Clinical chemistry: Changes in Concentration of Sodium

Part A. Assessed by blood sample collection

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

Clinical chemistry: Changes in Concentration of Potassium

Part A. Assessed by blood sample collection

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

Clinical chemistry: Changes in Concentration of Magnesium

Part A. Assessed by blood sample collection

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

Clinical chemistry: Changes in Concentration of Chloride

Part A. Assessed by blood sample collection

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

Clinical chemistry: Changes in Concentration of Fasting glucose

Part A. Assessed by blood sample collection

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

Clinical chemistry: Changes in Concentration of Creatinine

Part A. Assessed by blood sample collection

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

Hematology: Changes in Concentration of Hemoglobin

Part A. Assessed by blood sample collection

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

Hematology: Changes in Concentration of Hematocrit

Part A. Assessed by blood sample collection

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

Hematology: Changes in Concentration of Total and differential leukocyte count

Part A. Assessed by blood sample collection

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

Hematology: Changes in Concentration of Red blood cell count

Part A. Assessed by blood sample collection

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

Hematology: Changes in Concentration of Platelet count

Part A. Assessed by blood sample collection

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

Urinalysis parameters: Concentration of pH

Part A. Assessed by urine sample collection

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

Urinalysis parameters: Concentration of specific gravity

Part A. Assessed by urine sample collection

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

Urinalysis parameters: Concentration of Protein

Part A. Assessed by urine sample collection

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

Urinalysis parameters: Concentration of Glucose

Part A. Assessed by urine sample collection

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

Urinalysis parameters: Concentration of Bilirubin

Part A. Assessed by urine sample collection

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

Urinalysis parameters: Concentration of Blood

Part A. Assessed by urine sample collection

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

Urinalysis parameters: Concentration of Nitrite

Part A. Assessed by urine sample collection

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

Urinalysis parameters: Concentration of Urobilinogen

Part A. Assessed by urine sample collection

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

Urinalysis parameters: Concentration of Leukocyte esterase

Part A. Assessed by urine sample collection

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

∆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

Time frame: Up to 24 hours after Start of Infusion

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

Time frame: Up to 24 hours after Start of Infusion

Categorical outliers for QTcF

Part B

Time frame: Up to 24 hours after Start of Infusion

Categorical outliers for HR

Part B

Time frame: Up to 24 hours after Start of Infusion

Categorical outliers for PR

Part B

Time frame: Up to 24 hours after Start of Infusion

Categorical outliers for QRS

Part B

Time frame: Up to 24 hours after Start of Infusion

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

Part B

Time frame: Up to 24 hours after Start of Infusion

Carbetocin PK parameters: AUClast

Part B

Time frame: Up to 24 hours after Start of Infusion

Carbetocin PK parameters: AUCinf

Part B

Time frame: Up to 24 hours after Start of Infusion

Carbetocin PK parameters: AUC%extrap

Part B

Time frame: Up to 24 hours after Start of Infusion

Carbetocin PK parameters: Cmax

Part B

Time frame: Up to 24 hours after Start of Infusion

Carbetocin PK parameters: Tmax

Part B

Time frame: Up to 24 hours after Start of Infusion

Carbetocin PK parameters: t½

Part B

Time frame: Up to 24 hours after Start of Infusion

Carbetocin PK parameters: MRTinf

Part B

Time frame: Up to 24 hours after Start of Infusion

Carbetocin PK parameters: CL

Part B

Time frame: Up to 24 hours after Start of Infusion

Carbetocin PK parameters: Vss

Part B

Time frame: Up to 24 hours after Start of Infusion

Carbetocin PK parameters: Vz.

Part B

Time frame: Up to 24 hours after Start of Infusion

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

Part B

Time frame: Up to 24 hours after Start of Infusion

TEAEs

Part B

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

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

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

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

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

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

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

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

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

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".

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

Clinical chemistry: Changes in Concentration of Blood Urea Nitrogen

Part B. Assessed by blood sample collection

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

Clinical chemistry: Changes in Concentration of Bilirubin total

Part B. Assessed by blood sample collection

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

Clinical chemistry: Changes in Concentration of Bilirubin direct

Part B. Assessed by blood sample collection

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

Clinical chemistry: Changes in Concentration of Alkaline phosphatase

Part B. Assessed by blood sample collection

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

Clinical chemistry: Changes in Concentration of Aspartate aminotransferase

Part B. Assessed by blood sample collection

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

Clinical chemistry: Changes in Concentration of Alanine aminotransferase

Part B. Assessed by blood sample collection

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

Clinical chemistry: Changes in Concentration of Albumin

Part B. Assessed by blood sample collection

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

Clinical chemistry: Changes in Concentration of Sodium

Part B. Assessed by blood sample collection

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

Clinical chemistry: Changes in Concentration of Potassium

Part B. Assessed by blood sample collection

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

Clinical chemistry: Changes in Concentration of Magnesium

Part B. Assessed by blood sample collection

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

Clinical chemistry: Changes in Concentration of Chloride

Part B. Assessed by blood sample collection

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

Clinical chemistry: Changes in Concentration of Fasting glucose

Part B. Assessed by blood sample collection

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

Clinical chemistry: Changes in Concentration of Creatinine

Part B. Assessed by blood sample collection

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

Hematology: Changes in Concentration of Hemoglobin

Part B. Assessed by blood sample collection

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

Hematology: Changes in Concentration of Hematocrit

Part B. Assessed by blood sample collection

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

Hematology: Changes in Concentration of Total and Differential leukocyte count

Part B. Assessed by blood sample collection

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

Hematology: Changes in Concentration of Red blood cell count

Part B. Assessed by blood sample collection

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

Hematology: Changes in Concentration of Platelet count

Part B. Assessed by blood sample collection

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

Urinalysis parameters: Concentration of pH

Part B. Assessed by urine sample collection

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

Urinalysis parameters: Concentration of Specific gravity

Part B. Assessed by urine sample collection

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

Urinalysis parameters: Concentration of Protein

Part B. Assessed by urine sample collection

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

Urinalysis parameters: Concentration of Glucose

Part B. Assessed by urine sample collection

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

Urinalysis parameters: Concentration of Bilirubin

Part B. Assessed by urine sample collection

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

Urinalysis parameters: Concentration of Blood

Part B. Assessed by urine sample collection

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

Urinalysis parameters: Concentration of Nitrite

Part B. Assessed by urine sample collection

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

Urinalysis parameters: Concentration of Urobilinogen

Part B. Assessed by urine sample collection

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

Urinalysis parameters: Concentration of Leukocyte esterase

Part B. Assessed by urine sample collection

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