NT-814

Cmax,md,u: Maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval of the unbound analyte.

AUC: Area under the curve extrapolated to infinity. AUC(0-24)md,u: AUC from time 0 to 24 after multiple dosing of the unbound analyte.

CumAe(Urine): cumulative amount of Total Radioactivity (TR) excreted in urine.

Cum%Ae(Urine): cumulative amount of TR excreted in urine expressed as a percentage of the radioactive dose administered.

CumAe(Faeces): cumulative amount of TR excreted in faeces.

Cum%Ae(Faeces): cumulative amount of TR excreted in faeces expressed as a percentage of the radioactive dose administered.

CumAe(Total): cumulative amount of TR excreted in urine and faeces combined. The radioactivity associated with toilet tissue was also determined, and the results were reported for each subject as a single value for the whole collection period only and included in the calculation of total Ae and % of dose recovered. The data reported for total calculations excluded toilet tissue data for the 0 - 6 hours post-dose to 0 - 456 hours post-dose collection intervals and included toilet tissue data for the 0 - 480 hours post-dose collection interval.

Cum%Ae(Total): cumulative amount of TR excreted in urine and faeces combined expressed as a percentage of the radioactive dose administered. The radioactivity associated with toilet tissue was also determined, and the results were reported for each subject as a single value for the whole collection period only and included in the calculation of total Ae and % of dose recovered. The data reported for total calculations excluded toilet tissue data for the 0 - 6 hours post-dose to 0 - 456 hours post-dose collection intervals and included toilet tissue data for the 0 - 480 hours post-dose collection interval.

Cmax is the maximum observed plasma concentration of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration.

Time of occurrence of Cmax.Time to reach maximum plasma concentration of BAY3427080 was presented. Blood samples for Tmax were taken within 30 minutes prior to dose administration.

AUC from time zero extrapolated to infinity of BAY3427080 was presented. AUC0-∞ was only estimated following the Day 1 dose.

Area under the concentration-time curve (AUC) from time zero to the time of the last quantifiable concentration of BAY3427080 was presented. Blood samples for (AUC0-τ) were taken within 30 minutes prior to dose administration.

Terminal elimination half-life of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration.

Apparent clearance of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration.

A physician or appropriately qualified delegate conducted a full physical examination. Clinically significance was decided by investigator. The findings are presented as abnormal (clinically significant).

Reported results are cardiovascular system-examination findings at day 14. Clinically significance was decided by investigator. The findings are presented as abnormal (clinically significant).

Holter monitors were supplied by iCardiac Technologies. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14 and remained in place until 24-hour assessments were completed.

Diastolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in standing position.

Diastolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in sitting position.

Systolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in standing position.

Systolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in sitting position.

Pulse rate was measured just prior to dosing (approx. 30 mins).

Respiratory rate was measured just prior to dosing (approx. 30 mins).

Oxygen Saturation was measured just prior to dosing (approx. 30 mins).

Temperature was measured just prior to dosing (approx. 30 mins).

Weight was measured just prior to dosing (approx. 30 mins).

Blood samples for the assessment of ACTH and Estradiol were collected upon participants admission to the unit.

Blood samples for the assessment of Follicle Stimulating were collected upon participants admission to the unit.

Blood samples for the assessment of Triiodothyronine were collected upon participants admission to the unit.

Blood samples for the assessment of Thyrotropin were collected upon participants admission to the unit.

Blood samples for the assessment of Cortisol, Testosterone, Thyroxine and Triiodothyronine were collected upon participants admission to the unit.

Blood samples for the assessment of Cholesterol, Triglycerides,high-density lipoprotein (HDL)Cholesterol and low-density lipoprotein (LDL) Cholesterol were collected upon participants admission to the unit.

Blood samples for the assessment of Neutrophils/Leukocytes, Lymphocytes /Leukocytes, Monocytes/Leukocytes, Eosinophils/Leukocytes, Basophils/Leukocytes and Immature Granulocytes/ Leukocytes were collected upon participants admission to the unit.

Blood samples for the assessment of Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets were collected upon participant's admission to the unit.

Blood samples for the assessment of Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin (HB)concentration were collected upon participants admission to the unit.

Blood samples for the assessment of Erythrocytes were collected upon participants admission to the unit.

Blood samples for the assessment of Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume were collected upon participants admission to the unit.

Blood samples for the assessment of Erythrocytes Mean Corpuscular Hemoglobin were collected upon participants admission to the unit.

Blood samples for the assessment of Erythrocytes Distribution Width were collected upon participants admission to the unit. Erythrocytes distribution width (in percentage) = 1 SD of Erythrocyte volume/MCV x 100%

Blood samples for the assessment of Hematocrit were collected upon participants admission to the unit.

Blood samples for the assessment of Protein and Albumin were collected upon participants admission to the unit.

Blood samples for the assessment of Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase were collected upon participants admission to the unit.

Blood samples for the assessment of Urate, Bilirubin and Creatinine were collected upon participants admission to the unit.

Blood samples for the assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen were collected upon participant's admission to the unit.

Blood samples for the assessment of Glomerular Filtration Rate African were collected upon participants admission to the unit.

Blood samples for the assessment of Glomerular Filtration Rate Caucasian were collected upon participants admission to the unit.

Blood samples for the assessment of Prothrombin International Normalized Ratio were collected upon participants admission to the unit.

Blood samples for the assessment of Prothrombin Time and Activated Partial Thromboplastin Time were collected upon participants admission to the unit.

Heart rate was measured as part of the 12-lead electrocardiogram. Resting ECG recordings were made.Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14.

PR Interval was measured as part of the 12-lead electrocardiogram. Resting ECG recordings were made. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14.

QRS Duration was measured as part of the 12-lead electrocardiogram. Resting ECG recordings were made. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14.

QT Interval was measured as part of the 12-lead electrocardiogram. Resting ECG recordings were made. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14.

Fridericia-corrected QTcF interval was evaluated as part of the 12-lead electrocardiogram. Resting ECG recordings were made. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14.

Bazett-corrected QTcB interval was evaluated as part of the 12-lead electrocardiogram. Resting ECG recordings were made. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14.

An AE was defined as any untoward medical occurrence in a subject or clinical trial subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product. Serious Adverse Event (SAE) is an adverse event that at any dose: Results in death, Is life-threatening (i.e. the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it was more severe), Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, Is considered to be an important medical event.

An AE was defined as any untoward medical occurrence in a subject or clinical trial subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product. Serious Adverse Event (SAE) is an adverse event that at any dose: Results in death, Is life-threatening (i.e. the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it was more severe), Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, Is considered to be an important medical event.