Post-menopausal Vasomotor Symptoms
Conditions
Keywords
Hot flashes, Post-menopausal
Brief summary
This is a multi-center, double-blind, randomized, placebo-controlled multiple ascending dose study in post-menopausal women with vasomotor symptoms. Single ascending doses of NT-814 will be investigated in 4 cohorts. Each cohort will comprise of 20 subjects. Subjects will be dosed for 14 days.
Interventions
DRUGBAY3427080
DRUGPlacebo (for BAY3427080)
Sponsors
Nerre Therapeutics Ltd.
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Post-menopausal female subjects experiencing frequent moderate to severe hot flashes.Menopause will be defined as: * 12 months of spontaneous amenorrhea; * OR at least 6 weeks' post-surgical bilateral oophorectomy with or without hysterectomy.
Exclusion criteria
* BMI \> 35kg/m2. * Any active comorbid disease, ECG or laboratory result deemed by the investigator to be clinically significant and which could impact safety during study conduct or that could interfere with the study evaluation, procedures or completion. * Use of prohibited medications defined in the protocol. * Inability or unwillingness to comply with study procedures or requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Withdrawals Due to AEs up to Day 21 | On or after first drug administration up to end of study (Day 21) | 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. |
| Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Baseline (day -1) and day 14 | 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. |
| Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Baseline (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. |
| Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Baseline (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. |
| Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Baseline (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. |
| Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Baseline (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. |
| Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Baseline (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. |
| Nature and Severity of Adverse Events (AEs) up to Day 21 | On or after first drug administration up to end of study (Day 21). | 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. |
| Change From Baseline at Day 15 for Laboratory Hormones Results : Triiodothyronine Uptake | Baseline and day 15 | Blood samples for the assessment of Triiodothyronine were collected upon participants admission to the unit. |
| Change From Baseline at Day 15 for Laboratory Hormones Results: Thyrotropin | Baseline and day 15 | Blood samples for the assessment of Thyrotropin were collected upon participants admission to the unit. |
| Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) | Cmax is the maximum observed plasma concentration of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration. |
| Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080 | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) | 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. |
| Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of BAY3427080 | Day 1 (pre-dose and post-dose (0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 8.0, 12.0 and 24.0 hours) | 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 (AUC0-τ) of BAY3427080 | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) | 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 (t½) of BAY3427080 | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) | Terminal elimination half-life of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration. |
| Apparent Clearance (CL/F) of BAY3427080 | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) | Apparent clearance of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration. |
| Number of Participants With Clinically Significant Abnormalities Detected Upon Physical Examination. | At day 14 | 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). |
| Number of Participants With Clinically Significant Abnormalities on the 12-lead ECGs | At day 14 | Reported results are cardiovascular system-examination findings at day 14. Clinically significance was decided by investigator. The findings are presented as abnormal (clinically significant). |
| Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Baseline (day -1) and day 14 | 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. |
| Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Standing) | Baseline and day 14 | Diastolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in standing position. |
| Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Sitting) | Baseline and day 14 | Diastolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in sitting position. |
| Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Standing) | Baseline and day 14 | Systolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in standing position. |
| Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Sitting) | Baseline and day 14 | Systolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in sitting position. |
| Change From Baseline at Day 14 in Vital Signs: Pulse Rate | Baseline and day 14 | Pulse rate was measured just prior to dosing (approx. 30 mins). |
| Change From Baseline at Day 14 in Vital Signs: Respiratory Rate | Baseline and day 14 | Respiratory rate was measured just prior to dosing (approx. 30 mins). |
| Change From Baseline at Day 14 in Vital Signs: Oxygen Saturation | Baseline and day 14 | Oxygen Saturation was measured just prior to dosing (approx. 30 mins). |
| Change From Baseline at Day 14 in Vital Signs: Oral Body Temperature | Baseline and day 14 | Temperature was measured just prior to dosing (approx. 30 mins). |
| Change From Baseline at Day 14 in Vital Signs: Weight | Baseline and day 14 | Weight was measured just prior to dosing (approx. 30 mins). |
| Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. | Baseline and day 15 | Blood samples for the assessment of ACTH and Estradiol were collected upon participants admission to the unit. |
| Change From Baseline at Day 15 for Laboratory Hormones Results: Follicle Stimulating Hormone | Baseline and day 15 | Blood samples for the assessment of Follicle Stimulating were collected upon participants admission to the unit. |
| Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Baseline and day 15 | Blood samples for the assessment of Cortisol, Testosterone, Thyroxine and Triiodothyronine were collected upon participants admission to the unit. |
| Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Baseline and day 14 | 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. |
| Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline and day 14 | 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. |
| Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline and day 14 | 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. |
| Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration | Baseline and day 14 | Blood samples for the assessment of Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin (HB)concentration were collected upon participants admission to the unit. |
| Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes | Baseline and day 14 | Blood samples for the assessment of Erythrocytes were collected upon participants admission to the unit. |
| Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume. | Baseline and day 14 | Blood samples for the assessment of Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume were collected upon participants admission to the unit. |
| Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Hemoglobin | Baseline and day 14 | Blood samples for the assessment of Erythrocytes Mean Corpuscular Hemoglobin were collected upon participants admission to the unit. |
| Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Distribution Width. | Baseline and day 14 | 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% |
| Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hematocrit. | Baseline and day 14 | Blood samples for the assessment of Hematocrit were collected upon participants admission to the unit. |
| Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin. | Baseline and day 14 | Blood samples for the assessment of Protein and Albumin were collected upon participants admission to the unit. |
| Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline and day 14 | 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. |
| Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Baseline and day 14 | Blood samples for the assessment of Urate, Bilirubin and Creatinine were collected upon participants admission to the unit. |
| Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline and day 14 | 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. |
| Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate African at Baseline | At Baseline | Blood samples for the assessment of Glomerular Filtration Rate African were collected upon participants admission to the unit. |
| Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate Caucasian at Baseline | At Baseline | Blood samples for the assessment of Glomerular Filtration Rate Caucasian were collected upon participants admission to the unit. |
| Change From Baseline at Day 14 for COAGULATION: Prothrombin International Normalized Ratio (INR) | Baseline and day 14 | Blood samples for the assessment of Prothrombin International Normalized Ratio were collected upon participants admission to the unit. |
| Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time | Baseline and day 14 | Blood samples for the assessment of Prothrombin Time and Activated Partial Thromboplastin Time were collected upon participants admission to the unit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (Week -1) at Weeks 1, 2 in Frequency of Moderate to Severe Hot Flushes as Measured by Twice Daily Paper Diary Throughout Study | Baseline (week -1) and Week 1 ,Week 2 | Hot flush frequency and hot flush severity were obtained using the Hot Flush paper Diary. Subjects documented the number of individual hot flushes experienced and rated the severity of each on a scale of 1 to 3 (mild = 1, moderate = 2, severe = 3). The diaries were completed based on recall twice daily, in the morning and evening. |
| Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Severity of Hot Flushes as Measured by Twice Daily Paper Diary | Baseline (week -1) and weeks 1, Week 2 | Participants documented the number of individual hot flushes experienced and rated the severity of each on a scale of 1 to 3 (mild = 1, moderate = 2, severe = 3). The diaries were completed based on recall twice daily, in the morning and evening. |
| Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Hot Flushes Severity Score as Measured by Twice Daily Paper Diary. | Baseline (week -1) and week 1 , 2 | The hot flushes severity score was a composite of the frequency and severity of hot flushes, and was calculated as follows: number of mild hot flushes recorded on Day Y + number of moderate hot flushes recorded on Day Y × 2 + number of severe hot flushes recorded on Day Y × 3. Higher scores mean more severe hot flushes. |
| Change in Frequency From Baseline (Day -1), at Days 7, 14 of Hot Flushes as Measured by Continuous Day Time Diary. | Baseline(day -1) and Day 7, 14 | Subjects recorded each hot flush and its severity on a scale of 1 to 3 (mild = 1, moderate = 2, severe = 3) in the hot flush paper diary as they occurred during the day and night. |
| Change From Baseline (Week -1) at Weeks 1, 2 in Night-time Awakenings (NTA) Secondary to Hot Flushes as Measured by Paper Diary | Baseline (week-1) and weeks 1 , 2 | The number of NTAs secondary to hot flushes was the sum of the number of moderate and severe night-time hot flushes recorded the following morning (twice-daily hot flush diary) or recorded contemporaneously on the continuous diary. |
| Change From Baseline (Day-1) to Day 1 and Day 7 in Luteinizing Hormone (AUC0-8) | baseline (day-1) to day 1 and day 7, pre-dose and post-dose (0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 8.0, 12.0 and 24.0 hours) | Change in Luteinizing Hormone(LH) AUC from time zero to 8 hours. Pre-dose samples for LH were taken within 30 minutes prior to dose administration. |
| Change in Frequency of Hot Flushes From Baseline (Day -1) at Days 7, 14 as Assessed by Skin Conductance | Baseline (day -1) and days 7, 14 | Sternal skin conductance monitors (the Bahr MonitorTM) and the associated algorithm software were supplied by Simplex Scientific LLC (Middleton, USA). Participants were instructed to push a button on the skin conductance monitor when they sensed a hot flush when fitted with the monitor and then provide details of the hot flush in the continuous hot flush diary. Sternal skin conductance monitors were fitted on Day -1 (24 hours±1 hour prior to the planned study drug administration on Day 1) and remained in place until after the Day 7 24-hour assessments were completed (on Day 8). Refitted around 30 minutes prior to study drug administration on Day 14 and remained in place until after the 24-hour assessments were completed on Day 15. |
Countries
United States
Participant flow
Recruitment details
The study was conducted between 01 August 2016 (first subject, screening visit) and 28 March 2017 (last subject, last visit).
Pre-assignment details
Overall 316 subjects were screened, of them 240 were screening failure. 76 subjects were randomized and assigned to treatment. 18 subjects were randomized to placebo and 58 subjects to BAY3427080 (NT-814) arms. 2 subjects discontinued the study .
Participants by arm
| Arm | Count |
|---|---|
| Placebo Comparator Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose. | 18 |
| 50 mg BAY3427080 50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days. | 15 |
| 100 mg BAY3427080 100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days | 15 |
| 150 mg BAY3427080 150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days. | 15 |
| 300 mg of BAY3427080 300 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days. | 13 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | 50 mg BAY3427080 | 100 mg BAY3427080 | Placebo Comparator | 150 mg BAY3427080 | 300 mg of BAY3427080 |
|---|---|---|---|---|---|---|
| Age, Continuous | 55.4 Years STANDARD_DEVIATION 4.67 | 55.9 Years STANDARD_DEVIATION 5.57 | 55.3 Years STANDARD_DEVIATION 5.43 | 55.2 Years STANDARD_DEVIATION 4.08 | 56.7 Years STANDARD_DEVIATION 4.37 | 53.8 Years STANDARD_DEVIATION 3.88 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 50 Participants | 10 Participants | 8 Participants | 13 Participants | 10 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 5 Participants | 7 Participants | 5 Participants | 5 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 4 Participants | 4 Participants | 2 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 62 Participants | 11 Participants | 11 Participants | 16 Participants | 13 Participants | 11 Participants |
| Sex: Female, Male Female | 76 Participants | 15 Participants | 15 Participants | 18 Participants | 15 Participants | 13 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Weight | 72.48 kg STANDARD_DEVIATION 11.2 | 70.85 kg STANDARD_DEVIATION 11.82 | 73.47 kg STANDARD_DEVIATION 14.93 | 73.25 kg STANDARD_DEVIATION 10.11 | 72.10 kg STANDARD_DEVIATION 7.1 | 72.73 kg STANDARD_DEVIATION 12.05 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 13 |
| other Total, other adverse events | 13 / 18 | 7 / 15 | 11 / 15 | 10 / 15 | 11 / 13 |
| serious Total, serious adverse events | 0 / 18 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 13 |
Outcome results
Primary
Apparent Clearance (CL/F) of BAY3427080
Apparent clearance of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration.
Time frame: On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours)
Population: Participants who received placebo were not included in the PK population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| 50 mg BAY3427080 | Apparent Clearance (CL/F) of BAY3427080 | Day 7 | 19.944 L/hr | Geometric Coefficient of Variation 48.05 |
| 50 mg BAY3427080 | Apparent Clearance (CL/F) of BAY3427080 | Day 1 | 24.769 L/hr | Geometric Coefficient of Variation 38.43 |
| 50 mg BAY3427080 | Apparent Clearance (CL/F) of BAY3427080 | Day 14 | 21.353 L/hr | Geometric Coefficient of Variation 64.73 |
| 100 mg BAY3427080 | Apparent Clearance (CL/F) of BAY3427080 | Day 7 | 22.358 L/hr | Geometric Coefficient of Variation 63.83 |
| 100 mg BAY3427080 | Apparent Clearance (CL/F) of BAY3427080 | Day 1 | 64.700 L/hr | Geometric Coefficient of Variation 3.49 |
| 100 mg BAY3427080 | Apparent Clearance (CL/F) of BAY3427080 | Day 14 | 28.229 L/hr | Geometric Coefficient of Variation 86.34 |
| 150 mg BAY3427080 | Apparent Clearance (CL/F) of BAY3427080 | Day 14 | 29.050 L/hr | Geometric Coefficient of Variation 88.71 |
| 150 mg BAY3427080 | Apparent Clearance (CL/F) of BAY3427080 | Day 1 | 130.223 L/hr | Geometric Coefficient of Variation 66.73 |
| 150 mg BAY3427080 | Apparent Clearance (CL/F) of BAY3427080 | Day 7 | 24.182 L/hr | Geometric Coefficient of Variation 43.92 |
| 300 mg BAY3427080 | Apparent Clearance (CL/F) of BAY3427080 | Day 1 | 48.004 L/hr | Geometric Coefficient of Variation 101.01 |
| 300 mg BAY3427080 | Apparent Clearance (CL/F) of BAY3427080 | Day 7 | 23.329 L/hr | Geometric Coefficient of Variation 85.47 |
| 300 mg BAY3427080 | Apparent Clearance (CL/F) of BAY3427080 | Day 14 | 20.239 L/hr | Geometric Coefficient of Variation 99.68 |
Primary
Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-τ) of BAY3427080
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.
Time frame: On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours)
Population: Participants who received placebo were not included in the PK population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| 50 mg BAY3427080 | Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-τ) of BAY3427080 | Day 1 | 1400.167 hr*ng/mL | Geometric Coefficient of Variation 67.87 |
| 50 mg BAY3427080 | Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-τ) of BAY3427080 | Day 14 | 2341.55 hr*ng/mL | Geometric Coefficient of Variation 64.73 |
| 50 mg BAY3427080 | Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-τ) of BAY3427080 | Day 7 | 2506.97 hr*ng/mL | Geometric Coefficient of Variation 48.05 |
| 100 mg BAY3427080 | Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-τ) of BAY3427080 | Day 1 | 2341.882 hr*ng/mL | Geometric Coefficient of Variation 71.19 |
| 100 mg BAY3427080 | Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-τ) of BAY3427080 | Day 14 | 3542.41 hr*ng/mL | Geometric Coefficient of Variation 86.34 |
| 100 mg BAY3427080 | Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-τ) of BAY3427080 | Day 7 | 4472.76 hr*ng/mL | Geometric Coefficient of Variation 63.83 |
| 150 mg BAY3427080 | Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-τ) of BAY3427080 | Day 7 | 6202.894 hr*ng/mL | Geometric Coefficient of Variation 43.92 |
| 150 mg BAY3427080 | Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-τ) of BAY3427080 | Day 1 | 3012.793 hr*ng/mL | Geometric Coefficient of Variation 97.74 |
| 150 mg BAY3427080 | Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-τ) of BAY3427080 | Day 14 | 5163.500 hr*ng/mL | Geometric Coefficient of Variation 88.71 |
| 300 mg BAY3427080 | Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-τ) of BAY3427080 | Day 1 | 6527.569 hr*ng/mL | Geometric Coefficient of Variation 70.5 |
| 300 mg BAY3427080 | Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-τ) of BAY3427080 | Day 14 | 14822.860 hr*ng/mL | Geometric Coefficient of Variation 99.68 |
| 300 mg BAY3427080 | Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-τ) of BAY3427080 | Day 7 | 12859.660 hr*ng/mL | Geometric Coefficient of Variation 85.47 |
Primary
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of BAY3427080
AUC from time zero extrapolated to infinity of BAY3427080 was presented. AUC0-∞ was only estimated following the Day 1 dose.
Time frame: Day 1 (pre-dose and post-dose (0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 8.0, 12.0 and 24.0 hours)
Population: Participants in PK population with available data are reported. Participants who received placebo were not included in the PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 50 mg BAY3427080 | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of BAY3427080 | 2018.68 hr*ng/mL | Geometric Coefficient of Variation 38.43 |
| 100 mg BAY3427080 | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of BAY3427080 | 1545.58 hr*ng/mL | Geometric Coefficient of Variation 3.49 |
| 150 mg BAY3427080 | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of BAY3427080 | 1151.87 hr*ng/mL | Geometric Coefficient of Variation 66.73 |
| 300 mg BAY3427080 | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of BAY3427080 | 6249.52 hr*ng/mL | Geometric Coefficient of Variation 101.01 |
Primary
Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen.
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.
Time frame: Baseline and day 14
Population: Participants with available data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline ( Chloride) | -1.2 mmol/L | Standard Deviation 3.2 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Calcium) | 2.421 mmol/L | Standard Deviation 0.0803 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Bicarbonate) | 26.39 mmol/L | Standard Deviation 2.615 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Urea Nitrogen) | 0.14 mmol/L | Standard Deviation 2.359 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Bicarbonate) | 1.11 mmol/L | Standard Deviation 3.66 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Sodium) | 140.7 mmol/L | Standard Deviation 2.93 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Magnesium) | -0.009 mmol/L | Standard Deviation 0.046 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Magnesium) | 0.893 mmol/L | Standard Deviation 0.0732 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Sodium) | -0.9 mmol/L | Standard Deviation 2.91 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Glucose) | -0.113 mmol/L | Standard Deviation 0.9083 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Potassium) | 4.41 mmol/L | Standard Deviation 0.375 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Glucose) | 5.457 mmol/L | Standard Deviation 0.6417 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Phosphate) | 0.026 mmol/L | Standard Deviation 0.1602 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Potassium) | 0.06 mmol/L | Standard Deviation 0.478 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Urea Nitrogen) | 5.59 mmol/L | Standard Deviation 1.23 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Phosphate) | 1.240 mmol/L | Standard Deviation 0.151 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Chloride) | 102.8 mmol/L | Standard Deviation 2.94 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Calcium) | -0.032 mmol/L | Standard Deviation 0.1198 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Magnesium) | 0.001 mmol/L | Standard Deviation 0.0387 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Magnesium) | 0.885 mmol/L | Standard Deviation 0.0588 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Calcium) | 2.401 mmol/L | Standard Deviation 0.073 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Glucose) | 5.521 mmol/L | Standard Deviation 0.4157 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Phosphate) | 1.249 mmol/L | Standard Deviation 0.1277 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Bicarbonate) | 26.60 mmol/L | Standard Deviation 2.131 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Potassium) | 4.22 mmol/L | Standard Deviation 0.246 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Bicarbonate) | -0.93 mmol/L | Standard Deviation 3.575 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Calcium) | -0.044 mmol/L | Standard Deviation 0.1355 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Urea Nitrogen) | -0.14 mmol/L | Standard Deviation 1.07 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Phosphate) | -0.045 mmol/L | Standard Deviation 0.1457 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Sodium) | 140.3 mmol/L | Standard Deviation 2.05 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline ( Chloride) | 0.4 mmol/L | Standard Deviation 3.16 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Chloride) | 102.4 mmol/L | Standard Deviation 3.79 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Glucose) | -0.278 mmol/L | Standard Deviation 0.4006 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Potassium) | 0.22 mmol/L | Standard Deviation 0.323 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Sodium) | -0.7 mmol/L | Standard Deviation 2.97 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Urea Nitrogen) | 5.47 mmol/L | Standard Deviation 1.337 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Potassium) | 4.29 mmol/L | Standard Deviation 0.374 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Magnesium) | 0.001 mmol/L | Standard Deviation 0.0529 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Urea Nitrogen) | 4.67 mmol/L | Standard Deviation 1.274 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Sodium) | 140.0 mmol/L | Standard Deviation 1.65 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Sodium) | -0.5 mmol/L | Standard Deviation 2.28 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Potassium) | 0.15 mmol/L | Standard Deviation 0.427 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Chloride) | 100.7 mmol/L | Standard Deviation 2.32 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline ( Chloride) | 1.1 mmol/L | Standard Deviation 1.69 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Bicarbonate) | 27.47 mmol/L | Standard Deviation 1.642 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Bicarbonate) | 1.00 mmol/L | Standard Deviation 3.088 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Calcium) | 2.515 mmol/L | Standard Deviation 0.0998 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Calcium) | -0.144 mmol/L | Standard Deviation 0.1147 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Phosphate) | 1.268 mmol/L | Standard Deviation 0.1269 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Phosphate) | -0.052 mmol/L | Standard Deviation 0.1096 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Glucose) | 5.349 mmol/L | Standard Deviation 0.4957 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Glucose) | -0.173 mmol/L | Standard Deviation 0.3412 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Magnesium) | 0.881 mmol/L | Standard Deviation 0.0675 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Urea Nitrogen) | 0.20 mmol/L | Standard Deviation 0.826 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Calcium) | 2.411 mmol/L | Standard Deviation 0.0622 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Chloride) | 102.7 mmol/L | Standard Deviation 2.84 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Magnesium) | 0.006 mmol/L | Standard Deviation 0.0484 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Calcium) | -0.049 mmol/L | Standard Deviation 0.063 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Potassium) | -0.06 mmol/L | Standard Deviation 0.408 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Potassium) | 4.49 mmol/L | Standard Deviation 0.38 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Phosphate) | 0.027 mmol/L | Standard Deviation 0.1389 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Phosphate) | 1.280 mmol/L | Standard Deviation 0.1115 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Magnesium) | 0.905 mmol/L | Standard Deviation 0.0703 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Glucose) | 5.483 mmol/L | Standard Deviation 0.3943 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Sodium) | -2.5 mmol/L | Standard Deviation 3.23 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Glucose) | -0.098 mmol/L | Standard Deviation 0.4245 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Sodium) | 142.3 mmol/L | Standard Deviation 3.01 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Bicarbonate) | 26.20 mmol/L | Standard Deviation 1.699 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Urea Nitrogen) | 0.00 mmol/L | Standard Deviation 1.442 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Bicarbonate) | 2.00 mmol/L | Standard Deviation 2.204 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline ( Chloride) | -1.1 mmol/L | Standard Deviation 3.02 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Urea Nitrogen) | 5.30 mmol/L | Standard Deviation 1.198 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Bicarbonate) | 27.62 mmol/L | Standard Deviation 3.641 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Chloride) | 101.4 mmol/L | Standard Deviation 1.56 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Glucose) | 5.456 mmol/L | Standard Deviation 0.4401 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Bicarbonate) | 0.31 mmol/L | Standard Deviation 2.626 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Sodium) | 140.0 mmol/L | Standard Deviation 2.83 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Calcium) | -0.052 mmol/L | Standard Deviation 0.1103 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Potassium) | 0.31 mmol/L | Standard Deviation 0.614 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Urea Nitrogen) | -0.38 mmol/L | Standard Deviation 1.488 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Magnesium) | -0.027 mmol/L | Standard Deviation 0.0696 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Phosphate) | 1.272 mmol/L | Standard Deviation 0.1544 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Potassium) | 4.14 mmol/L | Standard Deviation 0.421 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline ( Chloride) | 0.8 mmol/L | Standard Deviation 2.88 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Magnesium) | 0.896 mmol/L | Standard Deviation 0.0836 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Glucose) | 0.025 mmol/L | Standard Deviation 0.3063 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Phosphate) | -0.038 mmol/L | Standard Deviation 0.2171 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Calcium) | 2.382 mmol/L | Standard Deviation 0.0928 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Day 14 Change from Baseline (Sodium) | 0.7 mmol/L | Standard Deviation 3.47 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Baseline (Urea Nitrogen) | 5.21 mmol/L | Standard Deviation 1.393 |
Primary
Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets.
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.
Time frame: Baseline and day 14
Population: Participants with available data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline( Leukocytes) | 6.73 10^9*cells/L | Standard Deviation 1.372 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline(Platelets ) | 8.1 10^9*cells/L | Standard Deviation 17.77 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline( Monocytes) | -0.033 10^9*cells/L | Standard Deviation 0.1117 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline(Eosinophils) | -0.017 10^9*cells/L | Standard Deviation 0.0995 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline(Basophils) | -0.008 10^9*cells/L | Standard Deviation 0.0148 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline (Neutrophils ) | -0.374 10^9*cells/L | Standard Deviation 1.1794 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline(Basophils) | 0.041 10^9*cells/L | Standard Deviation 0.0305 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline (Neutrophils) | 3.847 10^9*cells/L | Standard Deviation 1.0899 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline ( Eosinophils) | 0.202 10^9*cells/L | Standard Deviation 0.2325 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline( Leukocytes) | -0.60 10^9*cells/L | Standard Deviation 1.299 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline ( Monocytes) | 0.499 10^9*cells/L | Standard Deviation 0.0984 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline( Immature Granulocytes) | 0.00 10^9*cells/L | Standard Deviation 0 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline (Lymphocytes) | -0.172 10^9*cells/L | Standard Deviation 0.29 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline (Platelets ) | 263.4 10^9*cells/L | Standard Deviation 59.66 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline (Lymphocytes) | 2.148 10^9*cells/L | Standard Deviation 0.4905 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline( Immature Granulocytes) | 0.00 10^9*cells/L | Standard Deviation 0 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline(Eosinophils) | 0.021 10^9*cells/L | Standard Deviation 0.0719 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline (Neutrophils ) | 0.072 10^9*cells/L | Standard Deviation 0.7422 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline( Immature Granulocytes) | 0.00 10^9*cells/L | Standard Deviation 0 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline(Basophils) | -0.007 10^9*cells/L | Standard Deviation 0.009 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline ( Monocytes) | 0.479 10^9*cells/L | Standard Deviation 0.1051 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline (Platelets ) | 249.1 10^9*cells/L | Standard Deviation 61.67 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline( Monocytes) | -0.030 10^9*cells/L | Standard Deviation 0.1324 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline ( Eosinophils) | 0.185 10^9*cells/L | Standard Deviation 0.1814 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline(Basophils) | 0.031 10^9*cells/L | Standard Deviation 0.0264 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline( Leukocytes) | 6.54 10^9*cells/L | Standard Deviation 1.613 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline( Leukocytes) | -0.27 10^9*cells/L | Standard Deviation 1.134 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline (Neutrophils) | 3.493 10^9*cells/L | Standard Deviation 0.9737 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline (Lymphocytes) | 2.341 10^9*cells/L | Standard Deviation 0.7009 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline(Platelets ) | 4.5 10^9*cells/L | Standard Deviation 33.83 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline (Lymphocytes) | -0.301 10^9*cells/L | Standard Deviation 0.5336 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline( Immature Granulocytes) | 0.00 10^9*cells/L | Standard Deviation 0 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline (Neutrophils ) | -0.246 10^9*cells/L | Standard Deviation 0.5487 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline (Lymphocytes) | 2.242 10^9*cells/L | Standard Deviation 0.6199 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline(Basophils) | 0.028 10^9*cells/L | Standard Deviation 0.0321 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline (Lymphocytes) | -0.107 10^9*cells/L | Standard Deviation 0.3652 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline( Immature Granulocytes) | 0.00 10^9*cells/L | Standard Deviation 0 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline( Immature Granulocytes) | 0.00 10^9*cells/L | Standard Deviation 0 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline (Platelets ) | 269.8 10^9*cells/L | Standard Deviation 61.4 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline (Neutrophils) | 3.779 10^9*cells/L | Standard Deviation 0.9332 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline( Monocytes) | 0.019 10^9*cells/L | Standard Deviation 0.0895 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline(Platelets ) | 13.5 10^9*cells/L | Standard Deviation 29.67 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline(Eosinophils) | -0.006 10^9*cells/L | Standard Deviation 0.0549 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline( Leukocytes) | 6.75 10^9*cells/L | Standard Deviation 1.245 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline(Basophils) | -0.001 10^9*cells/L | Standard Deviation 0.0305 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline ( Eosinophils) | 0.177 10^9*cells/L | Standard Deviation 0.109 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline ( Monocytes) | 0.505 10^9*cells/L | Standard Deviation 0.099 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline( Leukocytes) | -0.34 10^9*cells/L | Standard Deviation 0.686 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline (Neutrophils ) | -0.539 10^9*cells/L | Standard Deviation 0.9017 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline( Leukocytes) | -0.80 10^9*cells/L | Standard Deviation 1.011 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline (Neutrophils) | 3.745 10^9*cells/L | Standard Deviation 0.9686 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline (Lymphocytes) | -0.237 10^9*cells/L | Standard Deviation 0.3901 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline( Leukocytes) | 6.78 10^9*cells/L | Standard Deviation 1.307 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline (Lymphocytes) | 2.320 10^9*cells/L | Standard Deviation 0.6467 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline ( Monocytes) | 0.524 10^9*cells/L | Standard Deviation 0.141 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline( Monocytes) | -0.057 10^9*cells/L | Standard Deviation 0.1941 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline ( Eosinophils) | 0.177 10^9*cells/L | Standard Deviation 0.0954 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline(Eosinophils) | 0.005 10^9*cells/L | Standard Deviation 0.0436 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline(Basophils) | 0.027 10^9*cells/L | Standard Deviation 0.0301 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline(Basophils) | -0.010 10^9*cells/L | Standard Deviation 0.0259 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline( Immature Granulocytes) | 0.00 10^9*cells/L | Standard Deviation 0 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline( Immature Granulocytes) | 0.00 10^9*cells/L | Standard Deviation 0 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline (Platelets ) | 261.9 10^9*cells/L | Standard Deviation 46.91 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline(Platelets ) | 21.6 10^9*cells/L | Standard Deviation 24.58 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline( Immature Granulocytes) | 0.00 10^9*cells/L | Standard Deviation 0 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline ( Eosinophils) | 0.208 10^9*cells/L | Standard Deviation 0.1592 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline( Monocytes) | 0.002 10^9*cells/L | Standard Deviation 0.1643 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline (Lymphocytes) | 0.142 10^9*cells/L | Standard Deviation 0.6749 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline( Leukocytes) | 6.60 10^9*cells/L | Standard Deviation 1.896 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline( Immature Granulocytes) | 0.00 10^9*cells/L | Standard Deviation 0 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline (Lymphocytes) | 2.429 10^9*cells/L | Standard Deviation 0.9032 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline ( Monocytes) | 0.534 10^9*cells/L | Standard Deviation 0.1552 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline (Neutrophils ) | -0.186 10^9*cells/L | Standard Deviation 1.4444 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline(Platelets ) | 20.8 10^9*cells/L | Standard Deviation 74.35 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline (Platelets ) | 258.2 10^9*cells/L | Standard Deviation 52.57 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline (Neutrophils) | 3.394 10^9*cells/L | Standard Deviation 1.3264 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline(Basophils) | -0.002 10^9*cells/L | Standard Deviation 0.006 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Baseline(Basophils) | 0.030 10^9*cells/L | Standard Deviation 0.327 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline(Eosinophils) | -0.028 10^9*cells/L | Standard Deviation 0.1155 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Day 14 Change from Baseline( Leukocytes) | -0.06 10^9*cells/L | Standard Deviation 1.65 |
Primary
Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol.
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.
Time frame: Baseline and day 14
Population: Participants with available data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Baseline (Cholesterol) | 5.434 mmol/L | Standard Deviation 1.0223 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Day 14 Change from Baseline (Triglycerides) | 0.048 mmol/L | Standard Deviation 0.4936 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Day 14 Change from Baseline (Cholesterol) | 0.088 mmol/L | Standard Deviation 0.8629 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Baseline (Triglycerides) | 1.163 mmol/L | Standard Deviation 0.5796 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Baseline(HDL Cholesterol) | 1.717 mmol/L | Standard Deviation 0.4525 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Day 14 Change from Baseline( HDL Cholesterol) | -0.167 mmol/L | Standard Deviation 0.2824 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Baseline( LDL Cholesterol) | 3.226 mmol/L | Standard Deviation 1.0485 |
| Placebo | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Day 14 Change from Baseline ( LDL Cholesterol) | -0.013 mmol/L | Standard Deviation 0.3926 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Day 14 Change from Baseline (Triglycerides) | -0.071 mmol/L | Standard Deviation 0.4725 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Baseline (Cholesterol) | 5.471 mmol/L | Standard Deviation 0.6592 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Day 14 Change from Baseline ( LDL Cholesterol) | 0.184 mmol/L | Standard Deviation 0.2958 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Baseline( LDL Cholesterol) | 3.125 mmol/L | Standard Deviation 0.8436 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Baseline (Triglycerides) | 1.185 mmol/L | Standard Deviation 0.5036 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Day 14 Change from Baseline (Cholesterol) | -0.061 mmol/L | Standard Deviation 0.4761 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Day 14 Change from Baseline( HDL Cholesterol) | -0.219 mmol/L | Standard Deviation 0.2015 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Baseline(HDL Cholesterol) | 1.879 mmol/L | Standard Deviation 0.4052 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Day 14 Change from Baseline (Cholesterol) | -0.205 mmol/L | Standard Deviation 0.8981 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Baseline (Triglycerides) | 1.131 mmol/L | Standard Deviation 0.5889 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Day 14 Change from Baseline (Triglycerides) | -0.116 mmol/L | Standard Deviation 0.5247 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Baseline(HDL Cholesterol) | 1.7444 mmol/L | Standard Deviation 0.6563 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Day 14 Change from Baseline ( LDL Cholesterol) | -0.119 mmol/L | Standard Deviation 0.6747 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Day 14 Change from Baseline( HDL Cholesterol) | -0.056 mmol/L | Standard Deviation 0.2559 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Baseline( LDL Cholesterol) | 3.172 mmol/L | Standard Deviation 0.7654 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Baseline (Cholesterol) | 5.391 mmol/L | Standard Deviation 0.7346 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Day 14 Change from Baseline( HDL Cholesterol) | -0.147 mmol/L | Standard Deviation 0.1546 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Baseline (Triglycerides) | 1.329 mmol/L | Standard Deviation 0.6245 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Day 14 Change from Baseline (Cholesterol) | -0.185 mmol/L | Standard Deviation 0.6386 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Day 14 Change from Baseline ( LDL Cholesterol) | -0.038 mmol/L | Standard Deviation 0.649 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Day 14 Change from Baseline (Triglycerides) | -0.029 mmol/L | Standard Deviation 0.4178 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Baseline( LDL Cholesterol) | 3.625 mmol/L | Standard Deviation 0.7188 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Baseline (Cholesterol) | 5.804 mmol/L | Standard Deviation 0.6462 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Baseline(HDL Cholesterol) | 1.768 mmol/L | Standard Deviation 0.4716 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Baseline( LDL Cholesterol) | 3.552 mmol/L | Standard Deviation 1.1088 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Baseline (Cholesterol) | 5.393 mmol/L | Standard Deviation 0.9008 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Day 14 Change from Baseline( HDL Cholesterol) | -0.158 mmol/L | Standard Deviation 0.3132 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Day 14 Change from Baseline ( LDL Cholesterol) | -0.053 mmol/L | Standard Deviation 0.5944 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Baseline(HDL Cholesterol) | 1.449 mmol/L | Standard Deviation 0.2752 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Day 14 Change from Baseline (Cholesterol) | -0.321 mmol/L | Standard Deviation 0.679 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Day 14 Change from Baseline (Triglycerides) | -0.172 mmol/L | Standard Deviation 0.5633 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Baseline (Triglycerides) | 1.353 mmol/L | Standard Deviation 0.554 |
Primary
Change From Baseline at Day 14 for COAGULATION: Prothrombin International Normalized Ratio (INR)
Blood samples for the assessment of Prothrombin International Normalized Ratio were collected upon participants admission to the unit.
Time frame: Baseline and day 14
Population: Participants with available data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 14 for COAGULATION: Prothrombin International Normalized Ratio (INR) | Baseline | 0.993 INR | Standard Deviation 0.0428 |
| Placebo | Change From Baseline at Day 14 for COAGULATION: Prothrombin International Normalized Ratio (INR) | Day 14 Change from Baseline | -0.007 INR | Standard Deviation 0.0546 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for COAGULATION: Prothrombin International Normalized Ratio (INR) | Baseline | 1.013 INR | Standard Deviation 0.0552 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for COAGULATION: Prothrombin International Normalized Ratio (INR) | Day 14 Change from Baseline | -0.038 INR | Standard Deviation 0.0471 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for COAGULATION: Prothrombin International Normalized Ratio (INR) | Baseline | 1.007 INR | Standard Deviation 0.0482 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for COAGULATION: Prothrombin International Normalized Ratio (INR) | Day 14 Change from Baseline | 0.016 INR | Standard Deviation 0.0665 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for COAGULATION: Prothrombin International Normalized Ratio (INR) | Day 14 Change from Baseline | 0.013 INR | Standard Deviation 0.0359 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for COAGULATION: Prothrombin International Normalized Ratio (INR) | Baseline | 0.991 INR | Standard Deviation 0.0465 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for COAGULATION: Prothrombin International Normalized Ratio (INR) | Baseline | 0.993 INR | Standard Deviation 0.0645 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for COAGULATION: Prothrombin International Normalized Ratio (INR) | Day 14 Change from Baseline | 0.057 INR | Standard Deviation 0.2311 |
Primary
Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time
Blood samples for the assessment of Prothrombin Time and Activated Partial Thromboplastin Time were collected upon participants admission to the unit.
Time frame: Baseline and day 14
Population: Participants with available data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time | Day 14 Change from Baseline (Prothrombin Time) | -0.15 sec | Standard Deviation 0.507 |
| Placebo | Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time | Baseline (Prothrombin Time ) | 11.17 sec | Standard Deviation 1.871 |
| Placebo | Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time | Baseline(Activated Partial Thromboplastin Time) | 26.91 sec | Standard Deviation 2.435 |
| Placebo | Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time | Day 14 Change from Baseline (Activated Partial Thromboplastin Time) | -0.82 sec | Standard Deviation 1.35 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time | Day 14 Change from Baseline (Activated Partial Thromboplastin Time) | -1.80 sec | Standard Deviation 1.489 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time | Baseline(Activated Partial Thromboplastin Time) | 27.09 sec | Standard Deviation 2.495 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time | Day 14 Change from Baseline (Prothrombin Time) | -0.32 sec | Standard Deviation 0.351 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time | Baseline (Prothrombin Time ) | 11.05 sec | Standard Deviation 1.679 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time | Baseline(Activated Partial Thromboplastin Time) | 28.14 sec | Standard Deviation 2.483 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time | Day 14 Change from Baseline (Prothrombin Time) | 0.12 sec | Standard Deviation 0.503 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time | Baseline (Prothrombin Time ) | 11.91 sec | Standard Deviation 1.871 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time | Day 14 Change from Baseline (Activated Partial Thromboplastin Time) | -0.81 sec | Standard Deviation 1.478 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time | Baseline (Prothrombin Time ) | 11.51 sec | Standard Deviation 1.757 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time | Baseline(Activated Partial Thromboplastin Time) | 27.50 sec | Standard Deviation 2.872 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time | Day 14 Change from Baseline (Prothrombin Time) | 0.11 sec | Standard Deviation 0.291 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time | Day 14 Change from Baseline (Activated Partial Thromboplastin Time) | -0.87 sec | Standard Deviation 1.396 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time | Day 14 Change from Baseline (Prothrombin Time) | 0.55 sec | Standard Deviation 2.363 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time | Baseline (Prothrombin Time ) | 11.47 sec | Standard Deviation 1.589 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time | Baseline(Activated Partial Thromboplastin Time) | 27.55 sec | Standard Deviation 3.009 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time | Day 14 Change from Baseline (Activated Partial Thromboplastin Time) | 0.58 sec | Standard Deviation 3.196 |
Primary
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase
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.
Time frame: Baseline and day 14
Population: Participants with available data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Aspartate Aminotransferase) | 0.041 ukat/L | Standard Deviation 0.2197 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline(Alanine Aminotransferase) | 0.295 ukat/L | Standard Deviation 0.1302 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline (Aspartate Aminotransferase) | 0.344 ukat/L | Standard Deviation 0.076 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Alanine Aminotransferase) | 0.108 ukat/L | Standard Deviation 0.4103 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline (Alkaline Phosphatase) | 1.587 ukat/L | Standard Deviation 0.4829 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline (Creatine Kinase) | 1.957 ukat/L | Standard Deviation 0.8872 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Alkaline Phosphatase) | -0.129 ukat/L | Standard Deviation 0.3411 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Creatine Kinase) | 0.021 ukat/L | Standard Deviation 0.9758 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Gamma Glutamyl Transferase) | 0.101 ukat/L | Standard Deviation 0.389 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline (Gamma Glutamyl Transferase) | 0.309 ukat/L | Standard Deviation 0.174 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline (Creatine Kinase) | 2.047 ukat/L | Standard Deviation 1.0146 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline (Alkaline Phosphatase) | 1.397 ukat/L | Standard Deviation 0.3233 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Alkaline Phosphatase) | -0.130 ukat/L | Standard Deviation 0.2054 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline(Alanine Aminotransferase) | 0.331 ukat/L | Standard Deviation 0.1494 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline (Aspartate Aminotransferase) | 0.355 ukat/L | Standard Deviation 0.0632 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Aspartate Aminotransferase) | -0.035 ukat/L | Standard Deviation 0.0542 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline (Gamma Glutamyl Transferase) | 0.324 ukat/L | Standard Deviation 0.2085 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Gamma Glutamyl Transferase) | -0.035 ukat/L | Standard Deviation 0.098 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Creatine Kinase) | -0.260 ukat/L | Standard Deviation 0.4338 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Alanine Aminotransferase) | -0.049 ukat/L | Standard Deviation 0.1053 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Aspartate Aminotransferase) | -0.032 ukat/L | Standard Deviation 0.103 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Alkaline Phosphatase) | -0.172 ukat/L | Standard Deviation 0.1533 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline (Gamma Glutamyl Transferase) | 0.397 ukat/L | Standard Deviation 0.2111 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Gamma Glutamyl Transferase) | 0.001 ukat/L | Standard Deviation 0.1606 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline(Alanine Aminotransferase) | 0.279 ukat/L | Standard Deviation 0.1151 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Alanine Aminotransferase) | 0.049 ukat/L | — |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline (Alkaline Phosphatase) | 1.364 ukat/L | Standard Deviation 0.3219 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline (Aspartate Aminotransferase) | 0.343 ukat/L | Standard Deviation 0.095 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline (Creatine Kinase) | 1.907 ukat/L | Standard Deviation 1.1933 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Creatine Kinase) | -0.252 ukat/L | Standard Deviation 0.5078 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline (Creatine Kinase) | 1.895 ukat/L | Standard Deviation 1.2638 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Creatine Kinase) | -0.038 ukat/L | Standard Deviation 0.5689 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline(Alanine Aminotransferase) | 0.313 ukat/L | Standard Deviation 0.1281 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline (Gamma Glutamyl Transferase) | 0.561 ukat/L | Standard Deviation 0.7998 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline (Aspartate Aminotransferase) | 0.352 ukat/L | Standard Deviation 0.0737 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Alanine Aminotransferase) | -0.016 ukat/L | Standard Deviation 0.1391 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Gamma Glutamyl Transferase) | -0.190 ukat/L | Standard Deviation 0.462 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Aspartate Aminotransferase) | -0.009 ukat/L | Standard Deviation 0.0743 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline (Alkaline Phosphatase) | 1.397 ukat/L | Standard Deviation 0.3271 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Alkaline Phosphatase) | -0.203 ukat/L | Standard Deviation 0.2576 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Gamma Glutamyl Transferase) | 0.015 ukat/L | Standard Deviation 0.1959 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Alkaline Phosphatase) | -0.131 ukat/L | Standard Deviation 0.2958 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Aspartate Aminotransferase) | -0.032 ukat/L | Standard Deviation 0.2851 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline (Gamma Glutamyl Transferase) | 0.372 ukat/L | Standard Deviation 0.2272 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline (Aspartate Aminotransferase) | 0.401 ukat/L | Standard Deviation 0.1976 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline (Alkaline Phosphatase) | 1.407 ukat/L | Standard Deviation 0.4417 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline (Creatine Kinase) | 1.886 ukat/L | Standard Deviation 1.1854 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Alanine Aminotransferase) | 0.052 ukat/L | Standard Deviation 0.3923 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Baseline(Alanine Aminotransferase) | 0.413 ukat/L | Standard Deviation 0.1755 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Day 14 Change from Baseline (Creatine Kinase) | -0.269 ukat/L | Standard Deviation 0.5032 |
Primary
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin.
Blood samples for the assessment of Protein and Albumin were collected upon participants admission to the unit.
Time frame: Baseline and day 14
Population: Participants with available data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin. | Baseline (Protein) | 71.8 g/L | Standard Deviation 4.54 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin. | Day 14 Change from Baseline(Protein) | -4.0 g/L | Standard Deviation 3.11 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin. | Baseline(Albumin) | 42.9 g/L | Standard Deviation 6.75 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin. | Day 14 Change from Baseline (Albumin) | -0.6 g/L | Standard Deviation 6.42 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin. | Baseline (Protein) | 72.2 g/L | Standard Deviation 4.13 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin. | Day 14 Change from Baseline (Albumin) | -2.5 g/L | Standard Deviation 2.42 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin. | Day 14 Change from Baseline(Protein) | -2.5 g/L | Standard Deviation 4.39 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin. | Baseline(Albumin) | 44.3 g/L | Standard Deviation 1.84 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin. | Day 14 Change from Baseline (Albumin) | -3.2 g/L | Standard Deviation 2.08 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin. | Day 14 Change from Baseline(Protein) | -6.9 g/L | Standard Deviation 4.89 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin. | Baseline(Albumin) | 44.4 g/L | Standard Deviation 2.53 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin. | Baseline (Protein) | 74.3 g/L | Standard Deviation 4.25 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin. | Baseline (Protein) | 70.5 g/L | Standard Deviation 4.84 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin. | Day 14 Change from Baseline(Protein) | -4.1 g/L | Standard Deviation 2.64 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin. | Day 14 Change from Baseline (Albumin) | 0.3 g/L | Standard Deviation 2.05 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin. | Baseline(Albumin) | 44.7 g/L | Standard Deviation 2.53 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin. | Day 14 Change from Baseline (Albumin) | -1.8 g/L | Standard Deviation 2.44 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin. | Baseline(Albumin) | 43.2 g/L | Standard Deviation 2.67 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin. | Day 14 Change from Baseline(Protein) | -2.5 g/L | Standard Deviation 3.1 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin. | Baseline (Protein) | 69.2 g/L | Standard Deviation 4.22 |
Primary
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine.
Blood samples for the assessment of Urate, Bilirubin and Creatinine were collected upon participants admission to the unit.
Time frame: Baseline and day 14
Population: Participants with available data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Baseline (Bilirubin) | 7.61 umol/L | Standard Deviation 3.5 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Day 14 Change from Baseline (Urate) | -11.90 umol/L | Standard Deviation 41.38 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Day 14 Change from Baseline(Creatinine) | 2.652 umol/L | Standard Deviation 6.481 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Baseline (Urate) | 297.43 umol/L | Standard Deviation 41.896 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Baseline(Creatinine) | 71.162 umol/L | Standard Deviation 11.3215 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Day 14 Change from Baseline(Bilirubin) | -1.25 umol/L | Standard Deviation 3.225 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Day 14 Change from Baseline(Bilirubin) | -1.15 umol/L | Standard Deviation 2.654 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Baseline (Urate) | 318.23 umol/L | Standard Deviation 20.323 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Baseline(Creatinine) | 67.125 umol/L | Standard Deviation 8.0711 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Day 14 Change from Baseline (Urate) | -2.95 umol/L | Standard Deviation 28.511 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Day 14 Change from Baseline(Creatinine) | -1.885 umol/L | Standard Deviation 7.809 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Baseline (Bilirubin) | 8.44 umol/L | Standard Deviation 3.64 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Day 14 Change from Baseline(Creatinine) | -4.168 umol/L | Standard Deviation 7.6761 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Day 14 Change from Baseline(Bilirubin) | -1.00 umol/L | Standard Deviation 1.886 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Baseline (Bilirubin) | 7.19 umol/L | Standard Deviation 2.932 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Baseline (Urate) | 261.74 umol/L | Standard Deviation 57.222 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Day 14 Change from Baseline (Urate) | 2.57 umol/L | Standard Deviation 19.706 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Baseline(Creatinine) | 65.121 umol/L | Standard Deviation 9.8867 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Baseline (Bilirubin) | 6.96 umol/L | Standard Deviation 2.652 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Baseline (Urate) | 275.34 umol/L | Standard Deviation 75.528 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Day 14 Change from Baseline (Urate) | -12.76 umol/L | Standard Deviation 28.636 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Day 14 Change from Baseline(Bilirubin) | -0.01 umol/L | Standard Deviation 2.599 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Baseline(Creatinine) | 67.891 umol/L | Standard Deviation 9.1636 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Day 14 Change from Baseline(Creatinine) | -1.297 umol/L | Standard Deviation 6.6136 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Baseline(Creatinine) | 11.844 umol/L | Standard Deviation 8.9096 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Baseline (Bilirubin) | 7.23 umol/L | Standard Deviation 3.305 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Day 14 Change from Baseline (Urate) | -7.93 umol/L | Standard Deviation 44.269 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Baseline (Urate) | 212.17 umol/L | Standard Deviation 52.885 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Day 14 Change from Baseline(Bilirubin) | 0.40 umol/L | Standard Deviation 3.069 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Day 14 Change from Baseline(Creatinine) | -3.605 umol/L | Standard Deviation 5.6665 |
Primary
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes
Blood samples for the assessment of Erythrocytes were collected upon participants admission to the unit.
Time frame: Baseline and day 14
Population: Participants with available data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes | Day 14 Change from Baseline | -0.421 10^12*cells/L | Standard Deviation 0.175 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes | Baseline | 4.467 10^12*cells/L | Standard Deviation 0.2503 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes | Day 14 Change from Baseline | -0.301 10^12*cells/L | Standard Deviation 0.2694 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes | Baseline | 4.525 10^12*cells/L | Standard Deviation 0.2212 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes | Baseline | 4.459 10^12*cells/L | Standard Deviation 0.2962 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes | Day 14 Change from Baseline | -0.511 10^12*cells/L | Standard Deviation 0.2111 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes | Baseline | 4.365 10^12*cells/L | Standard Deviation 0.3678 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes | Day 14 Change from Baseline | -0.485 10^12*cells/L | Standard Deviation 0.1903 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes | Baseline | 4.518 10^12*cells/L | Standard Deviation 0.2368 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes | Day 14 Change from Baseline | -0.425 10^12*cells/L | Standard Deviation 0.2297 |
Primary
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Distribution Width.
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%
Time frame: Baseline and day 14
Population: Participants with available data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Distribution Width. | Baseline | 27.81 Percentage of Erythrocyte volume | Standard Deviation 15.478 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Distribution Width. | Day 14 Change from Baseline | -0.15 Percentage of Erythrocyte volume | Standard Deviation 0.916 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Distribution Width. | Day 14 Change from Baseline | 0.49 Percentage of Erythrocyte volume | Standard Deviation 0.863 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Distribution Width. | Baseline | 25.52 Percentage of Erythrocyte volume | Standard Deviation 15.413 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Distribution Width. | Day 14 Change from Baseline | -0.05 Percentage of Erythrocyte volume | Standard Deviation 1.878 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Distribution Width. | Baseline | 35.82 Percentage of Erythrocyte volume | Standard Deviation 16.476 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Distribution Width. | Baseline | 30.59 Percentage of Erythrocyte volume | Standard Deviation 16.089 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Distribution Width. | Day 14 Change from Baseline | -0.61 Percentage of Erythrocyte volume | Standard Deviation 0.696 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Distribution Width. | Day 14 Change from Baseline | -0.68 Percentage of Erythrocyte volume | Standard Deviation 0.778 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Distribution Width. | Baseline | 31.48 Percentage of Erythrocyte volume | Standard Deviation 17.013 |
Primary
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples for the assessment of Erythrocytes Mean Corpuscular Hemoglobin were collected upon participants admission to the unit.
Time frame: Baseline and day 14
Population: Participants with available data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Hemoglobin | Baseline | 28.89 pg | Standard Deviation 2.517 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Hemoglobin | Day 14 Change from Baseline | 0.09 pg | Standard Deviation 0.494 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Hemoglobin | Baseline | 29.50 pg | Standard Deviation 1.803 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Hemoglobin | Day 14 Change from Baseline | -0.19 pg | Standard Deviation 0.263 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Hemoglobin | Baseline | 28.79 pg | Standard Deviation 2.217 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Hemoglobin | Day 14 Change from Baseline | 0.03 pg | Standard Deviation 0.486 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Hemoglobin | Day 14 Change from Baseline | 0.15 pg | Standard Deviation 0.532 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Hemoglobin | Baseline | 29.39 pg | Standard Deviation 2.511 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Hemoglobin | Baseline | 28.89 pg | Standard Deviation 1.759 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Hemoglobin | Day 14 Change from Baseline | 0.17 pg | Standard Deviation 0.317 |
Primary
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume.
Blood samples for the assessment of Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume were collected upon participants admission to the unit.
Time frame: Baseline and day 14
Population: Participants with available data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume. | Day 14 Change from Baseline (Erythrocytes Mean Corpuscular Volume ) | 0.44 fL | Standard Deviation 1.155 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume. | Baseline (Mean Platelet Volume) | 9.79 fL | Standard Deviation 0.809 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume. | Baseline (Erythrocytes Mean Corpuscular Volume ) | 87.87 fL | Standard Deviation 5.707 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume. | Day 14 Change from Baseline (Mean Platelet Volume) | -0.14 fL | Standard Deviation 0.448 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume. | Day 14 Change from Baseline (Erythrocytes Mean Corpuscular Volume ) | 0.11 fL | Standard Deviation 0.799 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume. | Baseline (Erythrocytes Mean Corpuscular Volume ) | 87.69 fL | Standard Deviation 3.89 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume. | Day 14 Change from Baseline (Mean Platelet Volume) | 0.08 fL | Standard Deviation 0.412 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume. | Baseline (Mean Platelet Volume) | 9.91 fL | Standard Deviation 1.608 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume. | Baseline (Erythrocytes Mean Corpuscular Volume ) | 87.71 fL | Standard Deviation 4.717 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume. | Day 14 Change from Baseline (Erythrocytes Mean Corpuscular Volume ) | 0.47 fL | Standard Deviation 0.967 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume. | Day 14 Change from Baseline (Mean Platelet Volume) | -0.24 fL | Standard Deviation 0.22 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume. | Baseline (Mean Platelet Volume) | 10.22 fL | Standard Deviation 1.565 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume. | Day 14 Change from Baseline (Mean Platelet Volume) | -0.37 fL | Standard Deviation 0.403 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume. | Baseline (Mean Platelet Volume) | 10.19 fL | Standard Deviation 1.005 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume. | Day 14 Change from Baseline (Erythrocytes Mean Corpuscular Volume ) | 0.49 fL | — |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume. | Baseline (Erythrocytes Mean Corpuscular Volume ) | 89.42 fL | Standard Deviation 6.744 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume. | Day 14 Change from Baseline (Mean Platelet Volume) | -0.06 fL | Standard Deviation 0.216 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume. | Baseline (Erythrocytes Mean Corpuscular Volume ) | 88.63 fL | Standard Deviation 3.15 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume. | Baseline (Mean Platelet Volume) | 10.05 fL | Standard Deviation 1.179 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume. | Day 14 Change from Baseline (Erythrocytes Mean Corpuscular Volume ) | -0.27 fL | Standard Deviation 0.659 |
Primary
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hematocrit.
Blood samples for the assessment of Hematocrit were collected upon participants admission to the unit.
Time frame: Baseline and day 14
Population: Participants with available data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hematocrit. | Baseline | 39.18 Volume percentage | Standard Deviation 1.976 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hematocrit. | Day 14 Change from Baseline | -3.51 Volume percentage | Standard Deviation 1.307 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hematocrit. | Baseline | 39.63 Volume percentage | Standard Deviation 2.461 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hematocrit. | Day 14 Change from Baseline | -2.45 Volume percentage | Standard Deviation 2.106 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hematocrit. | Baseline | 38.99 Volume percentage | Standard Deviation 1.788 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hematocrit. | Day 14 Change from Baseline | -4.20 Volume percentage | Standard Deviation 1.877 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hematocrit. | Day 14 Change from Baseline | -4.13 Volume percentage | Standard Deviation 1.431 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hematocrit. | Baseline | 38.85 Volume percentage | Standard Deviation 1.99 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hematocrit. | Baseline | 40.02 Volume percentage | Standard Deviation 2.646 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hematocrit. | Day 14 Change from Baseline | -3.86 Volume percentage | Standard Deviation 2.163 |
Primary
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration
Blood samples for the assessment of Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin (HB)concentration were collected upon participants admission to the unit.
Time frame: Baseline and day 14
Population: Participants with available data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration | Baseline (Hemoglobin) | 128.9 g/L | Standard Deviation 8.53 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration | Day 14 Change from Baseline (Hemoglobin) | -11.8 g/L | Standard Deviation 4.99 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration | Baseline (Erythrocytes Mean Corpuscular HB concentration ) | 328.5 g/L | Standard Deviation 10.3 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration | Day 14 Change from Baseline (Erythrocytes Mean Corpuscular HB concentration) | -0.4 g/L | Standard Deviation 5.21 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration | Baseline (Hemoglobin) | 132.4 g/L | Standard Deviation 10.64 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration | Day 14 Change from Baseline (Erythrocytes Mean Corpuscular HB concentration) | -2.5 g/L | Standard Deviation 2.34 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration | Day 14 Change from Baseline (Hemoglobin) | -9.0 g/L | Standard Deviation 7.14 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration | Baseline (Erythrocytes Mean Corpuscular HB concentration ) | 335.2 g/L | Standard Deviation 9.42 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration | Day 14 Change from Baseline (Erythrocytes Mean Corpuscular HB concentration) | -2.3 g/L | Standard Deviation 6.94 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration | Day 14 Change from Baseline (Hemoglobin) | -14.6 g/L | Standard Deviation 5.98 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration | Baseline (Erythrocytes Mean Corpuscular HB concentration ) | 329.0 g/L | Standard Deviation 10.22 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration | Baseline (Hemoglobin) | 128.7 g/L | Standard Deviation 7.82 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration | Baseline (Hemoglobin) | 127.7 g/L | Standard Deviation 8.6 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration | Day 14 Change from Baseline (Hemoglobin) | -13.9 g/L | Standard Deviation 4.66 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration | Day 14 Change from Baseline (Erythrocytes Mean Corpuscular HB concentration) | -0.8 g/L | Standard Deviation 3.41 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration | Baseline (Erythrocytes Mean Corpuscular HB concentration ) | 328.2 g/L | Standard Deviation 7.51 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration | Day 14 Change from Baseline (Erythrocytes Mean Corpuscular HB concentration) | 3.2 g/L | Standard Deviation 4.62 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration | Baseline (Erythrocytes Mean Corpuscular HB concentration ) | 326.8 g/L | Standard Deviation 10.27 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration | Day 14 Change from Baseline (Hemoglobin) | -12.1 g/L | Standard Deviation 6.58 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration | Baseline (Hemoglobin) | 132.2 g/L | Standard Deviation 12.6 |
Primary
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes.
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.
Time frame: Baseline and day 14
Population: Participants with available data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline(Eosinophils/ Leukocytes) | 0.02 Percentage of total white blood cells | Standard Deviation 1.316 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline(Lymphocytes / Leukocytes) | 0.18 Percentage of total white blood cells | Standard Deviation 5.791 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline(Basophils/ Leukocytes) | 0.61 Percentage of total white blood cells | Standard Deviation 0.263 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline ( Monocytes / Leukocytes ) | 7.58 Percentage of total white blood cells | Standard Deviation 1.592 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline (Basophils/ Leukocytes) | -0.13 Percentage of total white blood cells | Standard Deviation 0.181 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline( Immature Granulocytes/ Leukocytes) | 0.15 Percentage of total white blood cells | Standard Deviation 0.084 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline( Monocytes/ Leukocytes) | 0.22 Percentage of total white blood cells | Standard Deviation 1.947 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline (Neutrophils/ Leukocytes) | 56.53 Percentage of total white blood cells | Standard Deviation 7.7 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline (Lymphocytes/ Leukocytes) | 32.40 Percentage of total white blood cells | Standard Deviation 7.098 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline ( Eosinophils/ Leukocytes) | 2.83 Percentage of total white blood cells | Standard Deviation 2.433 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline( Immature Granulocytes/ Leukocytes) | 0.03 Percentage of total white blood cells | Standard Deviation 0.082 |
| Placebo | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline (Neutrophils/ Leukocytes) | -0.29 Percentage of total white blood cells | Standard Deviation 7.788 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline (Neutrophils/ Leukocytes) | 2.41 Percentage of total white blood cells | Standard Deviation 6.119 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline(Eosinophils/ Leukocytes) | 0.29 Percentage of total white blood cells | Standard Deviation 0.961 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline( Immature Granulocytes/ Leukocytes) | -0.05 Percentage of total white blood cells | Standard Deviation 0.1 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline(Lymphocytes / Leukocytes) | -2.46 Percentage of total white blood cells | Standard Deviation 5.667 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline (Lymphocytes/ Leukocytes) | 35.57 Percentage of total white blood cells | Standard Deviation 5.439 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline( Immature Granulocytes/ Leukocytes) | 0.25 Percentage of total white blood cells | Standard Deviation 0.1 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline(Basophils/ Leukocytes) | 0.55 Percentage of total white blood cells | Standard Deviation 0.177 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline ( Eosinophils/ Leukocytes) | 3.04 Percentage of total white blood cells | Standard Deviation 3.352 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline ( Monocytes / Leukocytes ) | 7.47 Percentage of total white blood cells | Standard Deviation 1.379 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline (Neutrophils/ Leukocytes) | 53.31 Percentage of total white blood cells | Standard Deviation 4.994 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline( Monocytes/ Leukocytes) | -0.15 Percentage of total white blood cells | Standard Deviation 1.751 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline (Basophils/ Leukocytes) | -0.07 Percentage of total white blood cells | Standard Deviation 0.111 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline (Lymphocytes/ Leukocytes) | 33.33 Percentage of total white blood cells | Standard Deviation 8.024 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline( Immature Granulocytes/ Leukocytes) | 0.09 Percentage of total white blood cells | Standard Deviation 0.157 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline( Immature Granulocytes/ Leukocytes) | 0.20 Percentage of total white blood cells | Standard Deviation 0.151 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline ( Monocytes / Leukocytes ) | 7.62 Percentage of total white blood cells | Standard Deviation 1.591 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline (Neutrophils/ Leukocytes) | -0.50 Percentage of total white blood cells | Standard Deviation 5.047 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline( Monocytes/ Leukocytes) | 0.65 Percentage of total white blood cells | Standard Deviation 1.291 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline (Basophils/ Leukocytes) | -0.14 Percentage of total white blood cells | Standard Deviation 0.122 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline ( Eosinophils/ Leukocytes) | 2.64 Percentage of total white blood cells | Standard Deviation 1.422 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline(Eosinophils/ Leukocytes) | 0.06 Percentage of total white blood cells | Standard Deviation 0.794 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline (Neutrophils/ Leukocytes) | 55.65 Percentage of total white blood cells | Standard Deviation 8.318 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline(Basophils/ Leukocytes) | 0.66 Percentage of total white blood cells | Standard Deviation 0.295 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline(Lymphocytes / Leukocytes) | -0.11 Percentage of total white blood cells | Standard Deviation 4.763 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline (Basophils/ Leukocytes) | 0.01 Percentage of total white blood cells | Standard Deviation 0.209 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline (Lymphocytes/ Leukocytes) | 34.33 Percentage of total white blood cells | Standard Deviation 7.444 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline(Lymphocytes / Leukocytes) | 0.59 Percentage of total white blood cells | Standard Deviation 5.835 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline ( Monocytes / Leukocytes ) | 7.71 Percentage of total white blood cells | Standard Deviation 1.762 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline( Monocytes/ Leukocytes) | 0.05 Percentage of total white blood cells | Standard Deviation 2.758 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline ( Eosinophils/ Leukocytes) | 2.61 Percentage of total white blood cells | Standard Deviation 1.17 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline(Eosinophils/ Leukocytes) | 0.33 Percentage of total white blood cells | Standard Deviation 0.538 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline(Basophils/ Leukocytes) | 0.51 Percentage of total white blood cells | Standard Deviation 0.223 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline( Immature Granulocytes/ Leukocytes) | 0.13 Percentage of total white blood cells | Standard Deviation 0.111 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline( Immature Granulocytes/ Leukocytes) | 0.00 Percentage of total white blood cells | Standard Deviation 0.183 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline (Neutrophils/ Leukocytes) | 54.78 Percentage of total white blood cells | Standard Deviation 8.61 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline (Neutrophils/ Leukocytes) | -0.98 Percentage of total white blood cells | Standard Deviation 7.116 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline (Neutrophils/ Leukocytes) | 50.92 Percentage of total white blood cells | Standard Deviation 10.316 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline(Basophils/ Leukocytes) | 0.56 Percentage of total white blood cells | Standard Deviation 0.373 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline(Eosinophils/ Leukocytes) | -0.24 Percentage of total white blood cells | Standard Deviation 1.189 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline (Neutrophils/ Leukocytes) | -2.69 Percentage of total white blood cells | Standard Deviation 10.614 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline ( Eosinophils/ Leukocytes) | 3.05 Percentage of total white blood cells | Standard Deviation 1.979 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline( Monocytes/ Leukocytes) | 0.22 Percentage of total white blood cells | Standard Deviation 3.85 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline ( Monocytes / Leukocytes ) | 8.62 Percentage of total white blood cells | Standard Deviation 3.276 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline( Immature Granulocytes/ Leukocytes) | 0.15 Percentage of total white blood cells | Standard Deviation 0.084 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline(Lymphocytes / Leukocytes) | 2.75 Percentage of total white blood cells | Standard Deviation 10.926 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline (Basophils/ Leukocytes) | -0.05 Percentage of total white blood cells | Standard Deviation 0.307 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Baseline (Lymphocytes/ Leukocytes) | 36.78 Percentage of total white blood cells | Standard Deviation 10.446 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Day 14 Change from Baseline( Immature Granulocytes/ Leukocytes) | 0.03 Percentage of total white blood cells | Standard Deviation 0.137 |
Primary
Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Sitting)
Diastolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in sitting position.
Time frame: Baseline and day 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Sitting) | Baseline | 77.72 mmHg | Standard Deviation 6.542 |
| Placebo | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Sitting) | Day 14 Change from Baseline | 0.11 mmHg | Standard Deviation 9.292 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Sitting) | Day 14 Change from Baseline | -0.53 mmHg | Standard Deviation 6.906 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Sitting) | Baseline | 74.27 mmHg | Standard Deviation 6.239 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Sitting) | Day 14 Change from Baseline | -0.79 mmHg | Standard Deviation 9.736 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Sitting) | Baseline | 77.20 mmHg | Standard Deviation 10.705 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Sitting) | Day 14 Change from Baseline | 2.73 mmHg | Standard Deviation 9.384 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Sitting) | Baseline | 74.80 mmHg | Standard Deviation 6.774 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Sitting) | Day 14 Change from Baseline | 1.77 mmHg | Standard Deviation 6.366 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Sitting) | Baseline | 74.15 mmHg | Standard Deviation 8.245 |
Primary
Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Standing)
Diastolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in standing position.
Time frame: Baseline and day 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Standing) | Day 14 Change from Baseline | 1.11 mmHg | Standard Deviation 9.579 |
| Placebo | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Standing) | Baseline | 80.11 mmHg | Standard Deviation 4.702 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Standing) | Day 14 Change from Baseline | 2.53 mmHg | Standard Deviation 5.54 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Standing) | Baseline | 76.07 mmHg | Standard Deviation 5.257 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Standing) | Day 14 Change from Baseline | -0.07 mmHg | Standard Deviation 12.137 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Standing) | Baseline | 77.67 mmHg | Standard Deviation 11.462 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Standing) | Baseline | 78.93 mmHg | Standard Deviation 6.147 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Standing) | Day 14 Change from Baseline | 0.93 mmHg | Standard Deviation 7.216 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Standing) | Day 14 Change from Baseline | 1.62 mmHg | Standard Deviation 9.097 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Standing) | Baseline | 77.92 mmHg | Standard Deviation 9.768 |
Primary
Change From Baseline at Day 14 in Vital Signs: Oral Body Temperature
Temperature was measured just prior to dosing (approx. 30 mins).
Time frame: Baseline and day 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 14 in Vital Signs: Oral Body Temperature | Baseline | 36.77 Degree Celius | Standard Deviation 0.19 |
| Placebo | Change From Baseline at Day 14 in Vital Signs: Oral Body Temperature | Day 14 Change from Baseline | -0.04 Degree Celius | Standard Deviation 0.243 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Oral Body Temperature | Baseline | 36.65 Degree Celius | Standard Deviation 0.155 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Oral Body Temperature | Day 14 Change from Baseline | 0.06 Degree Celius | Standard Deviation 0.172 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Oral Body Temperature | Baseline | 36.79 Degree Celius | Standard Deviation 0.162 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Oral Body Temperature | Day 14 Change from Baseline | -0.09 Degree Celius | Standard Deviation 0.264 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Oral Body Temperature | Day 14 Change from Baseline | -0.01 Degree Celius | Standard Deviation 0.239 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Oral Body Temperature | Baseline | 36.71 Degree Celius | Standard Deviation 0.168 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Oral Body Temperature | Baseline | 36.77 Degree Celius | Standard Deviation 0.361 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Oral Body Temperature | Day 14 Change from Baseline | -0.05 Degree Celius | Standard Deviation 0.458 |
Primary
Change From Baseline at Day 14 in Vital Signs: Oxygen Saturation
Oxygen Saturation was measured just prior to dosing (approx. 30 mins).
Time frame: Baseline and day 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 14 in Vital Signs: Oxygen Saturation | Baseline | 98.50 Percentage of Oxygen satuartion | Standard Deviation 1.098 |
| Placebo | Change From Baseline at Day 14 in Vital Signs: Oxygen Saturation | Day 14 Change from Baseline | -0.61 Percentage of Oxygen satuartion | Standard Deviation 1.539 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Oxygen Saturation | Baseline | 98.40 Percentage of Oxygen satuartion | Standard Deviation 1.404 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Oxygen Saturation | Day 14 Change from Baseline | -0.73 Percentage of Oxygen satuartion | Standard Deviation 1.486 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Oxygen Saturation | Baseline | 97.87 Percentage of Oxygen satuartion | Standard Deviation 1.727 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Oxygen Saturation | Day 14 Change from Baseline | 0.29 Percentage of Oxygen satuartion | Standard Deviation 2.091 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Oxygen Saturation | Day 14 Change from Baseline | 0.20 Percentage of Oxygen satuartion | Standard Deviation 1.424 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Oxygen Saturation | Baseline | 97.67 Percentage of Oxygen satuartion | Standard Deviation 1.496 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Oxygen Saturation | Baseline | 97.31 Percentage of Oxygen satuartion | Standard Deviation 1.251 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Oxygen Saturation | Day 14 Change from Baseline | 0.38 Percentage of Oxygen satuartion | Standard Deviation 1.193 |
Primary
Change From Baseline at Day 14 in Vital Signs: Pulse Rate
Pulse rate was measured just prior to dosing (approx. 30 mins).
Time frame: Baseline and day 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 14 in Vital Signs: Pulse Rate | Baseline | 69.89 beats/min | Standard Deviation 8.629 |
| Placebo | Change From Baseline at Day 14 in Vital Signs: Pulse Rate | Day 14 Change from Baseline | 1.06 beats/min | Standard Deviation 8.271 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Pulse Rate | Baseline | 66.00 beats/min | Standard Deviation 6.358 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Pulse Rate | Day 14 Change from Baseline | -2.00 beats/min | Standard Deviation 8.027 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Pulse Rate | Baseline | 69.20 beats/min | Standard Deviation 9.966 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Pulse Rate | Day 14 Change from Baseline | 0.14 beats/min | Standard Deviation 7.263 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Pulse Rate | Day 14 Change from Baseline | 0.27 beats/min | Standard Deviation 8.388 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Pulse Rate | Baseline | 68.40 beats/min | Standard Deviation 4.611 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Pulse Rate | Baseline | 72.62 beats/min | Standard Deviation 7.136 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Pulse Rate | Day 14 Change from Baseline | -11.00 beats/min | Standard Deviation 9.618 |
Primary
Change From Baseline at Day 14 in Vital Signs: Respiratory Rate
Respiratory rate was measured just prior to dosing (approx. 30 mins).
Time frame: Baseline and day 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 14 in Vital Signs: Respiratory Rate | Baseline | 15.39 breaths/min | Standard Deviation 1.378 |
| Placebo | Change From Baseline at Day 14 in Vital Signs: Respiratory Rate | Day 14 Change from Baseline | -0.11 breaths/min | Standard Deviation 2.22 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Respiratory Rate | Day 14 Change from Baseline | -0.40 breaths/min | Standard Deviation 2.197 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Respiratory Rate | Baseline | 15.47 breaths/min | Standard Deviation 1.727 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Respiratory Rate | Baseline | 15.73 breaths/min | Standard Deviation 1.624 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Respiratory Rate | Day 14 Change from Baseline | 0.07 breaths/min | Standard Deviation 1.94 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Respiratory Rate | Baseline | 15.60 breaths/min | Standard Deviation 1.502 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Respiratory Rate | Day 14 Change from Baseline | -0.43 breaths/min | Standard Deviation 2.065 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Respiratory Rate | Day 14 Change from Baseline | -1.33 breaths/min | Standard Deviation 1.923 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Respiratory Rate | Baseline | 15.85 breaths/min | Standard Deviation 1.573 |
Primary
Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Sitting)
Systolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in sitting position.
Time frame: Baseline and day 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Sitting) | Baseline | 116.39 mmHg | Standard Deviation 11.304 |
| Placebo | Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Sitting) | Day 14 Change from Baseline | 4.17 mmHg | Standard Deviation 11.868 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Sitting) | Baseline | 113.80 mmHg | Standard Deviation 9.405 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Sitting) | Day 14 Change from Baseline | 0.20 mmHg | Standard Deviation 10.359 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Sitting) | Baseline | 119.07 mmHg | Standard Deviation 15.931 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Sitting) | Day 14 Change from Baseline | -2.79 mmHg | Standard Deviation 16.47 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Sitting) | Baseline | 117.20 mmHg | Standard Deviation 10.638 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Sitting) | Day 14 Change from Baseline | 2.47 mmHg | Standard Deviation 16.89 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Sitting) | Day 14 Change from Baseline | 5.62 mmHg | Standard Deviation 12.672 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Sitting) | Baseline | 114.15 mmHg | Standard Deviation 14.288 |
Primary
Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Standing)
Systolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in standing position.
Time frame: Baseline and day 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Standing) | Baseline | 117.83 mmHg | Standard Deviation 10.733 |
| Placebo | Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Standing) | Day 14 Change from Baseline | 5.11 mmHg | Standard Deviation 11.483 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Standing) | Baseline | 114.60 mmHg | Standard Deviation 8.675 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Standing) | Day 14 Change from Baseline | 3.80 mmHg | Standard Deviation 13.311 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Standing) | Baseline | 121.33 mmHg | Standard Deviation 17.867 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Standing) | Day 14 Change from Baseline | -4.43 mmHg | Standard Deviation 18.744 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Standing) | Day 14 Change from Baseline | 0.33 mmHg | Standard Deviation 12.234 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Standing) | Baseline | 118.87 mmHg | Standard Deviation 11.513 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Standing) | Baseline | 114.77 mmHg | Standard Deviation 15.095 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Standing) | Day 14 Change from Baseline | 5.62 mmHg | Standard Deviation 16.536 |
Primary
Change From Baseline at Day 14 in Vital Signs: Weight
Weight was measured just prior to dosing (approx. 30 mins).
Time frame: Baseline and day 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 14 in Vital Signs: Weight | Day 14 Change from Baseline | 0.36 Kilograms | Standard Deviation 1.034 |
| Placebo | Change From Baseline at Day 14 in Vital Signs: Weight | Baseline | 73.25 Kilograms | Standard Deviation 10.115 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Weight | Baseline | 70.85 Kilograms | Standard Deviation 11.821 |
| 50 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Weight | Day 14 Change from Baseline | 0.51 Kilograms | Standard Deviation 0.983 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Weight | Baseline | 73.47 Kilograms | Standard Deviation 14.934 |
| 100 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Weight | Day 14 Change from Baseline | 0.24 Kilograms | Standard Deviation 0.916 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Weight | Baseline | 72.10 Kilograms | Standard Deviation 7.104 |
| 150 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Weight | Day 14 Change from Baseline | 0.15 Kilograms | Standard Deviation 0.926 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Weight | Baseline | 72.73 Kilograms | Standard Deviation 12.047 |
| 300 mg BAY3427080 | Change From Baseline at Day 14 in Vital Signs: Weight | Day 14 Change from Baseline | 0.01 Kilograms | Standard Deviation 0.704 |
Primary
Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol.
Blood samples for the assessment of ACTH and Estradiol were collected upon participants admission to the unit.
Time frame: Baseline and day 15
Population: Participants with available data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. | Baseline (ADTH) | 5.34 pmol/L | Standard Deviation 3.402 |
| Placebo | Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. | Baseline (Estradiol) | 57.33 pmol/L | Standard Deviation 43.236 |
| Placebo | Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. | Day 15 Change from Baseline (Estradiol) | 22.43 pmol/L | Standard Deviation 141.618 |
| Placebo | Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. | Day 15 Change from Baseline (ADTH) | -0.49 pmol/L | Standard Deviation 3.333 |
| 50 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. | Day 15 Change from Baseline (Estradiol) | 13.21 pmol/L | Standard Deviation 80.704 |
| 50 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. | Day 15 Change from Baseline (ADTH) | -0.68 pmol/L | Standard Deviation 2.035 |
| 50 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. | Baseline (ADTH) | 4.17 pmol/L | Standard Deviation 1.991 |
| 50 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. | Baseline (Estradiol) | 59.49 pmol/L | Standard Deviation 40.129 |
| 100 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. | Day 15 Change from Baseline (Estradiol) | 0.53 pmol/L | Standard Deviation 3.172 |
| 100 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. | Baseline (ADTH) | 3.87 pmol/L | Standard Deviation 2.361 |
| 100 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. | Baseline (Estradiol) | 35.02 pmol/L | Standard Deviation 25.556 |
| 100 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. | Day 15 Change from Baseline (ADTH) | 0.84 pmol/L | Standard Deviation 1.914 |
| 150 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. | Day 15 Change from Baseline (ADTH) | 1.04 pmol/L | Standard Deviation 3.059 |
| 150 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. | Baseline (ADTH) | 3.55 pmol/L | Standard Deviation 2.36 |
| 150 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. | Baseline (Estradiol) | 43.83 pmol/L | Standard Deviation 31.27 |
| 150 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. | Day 15 Change from Baseline (Estradiol) | 1.96 pmol/L | Standard Deviation 12.394 |
| 300 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. | Baseline (ADTH) | 3.27 pmol/L | Standard Deviation 2.011 |
| 300 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. | Day 15 Change from Baseline (ADTH) | 1.67 pmol/L | Standard Deviation 3.059 |
| 300 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. | Day 15 Change from Baseline (Estradiol) | -9.02 pmol/L | Standard Deviation 87.48 |
| 300 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. | Baseline (Estradiol) | 62.42 pmol/L | Standard Deviation 42.589 |
Primary
Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine
Blood samples for the assessment of Cortisol, Testosterone, Thyroxine and Triiodothyronine were collected upon participants admission to the unit.
Time frame: Baseline and day 15
Population: Participants with available data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Day 15 Change from Baseline (Testosterone) | 0.057 nmol/L | Standard Deviation 0.3567 |
| Placebo | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Baseline (Testosterone) | 0.744 nmol/L | Standard Deviation 0.385 |
| Placebo | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Baseline (Cortisol) | 348.60 nmol/L | Standard Deviation 156.496 |
| Placebo | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Day 15 Change from Baseline (Triiodothyronine) | -0.190 nmol/L | Standard Deviation 0.3171 |
| Placebo | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Baseline(Thyroxine) | 95.44 nmol/L | Standard Deviation 14.576 |
| Placebo | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Day 15 Change from Baseline (Cortisol) | 15.94 nmol/L | Standard Deviation 193.564 |
| Placebo | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Baseline(Triiodothyronine) | 1.865 nmol/L | Standard Deviation 0.14131 |
| Placebo | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Day 15 Change from Baseline(Thyroxine) | -3.78 nmol/L | Standard Deviation 14.771 |
| 50 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Day 15 Change from Baseline (Triiodothyronine) | -0.141 nmol/L | Standard Deviation 0.2742 |
| 50 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Day 15 Change from Baseline (Cortisol) | -23.32 nmol/L | Standard Deviation 172.685 |
| 50 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Baseline(Thyroxine) | 95.66 nmol/L | Standard Deviation 15.203 |
| 50 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Baseline (Cortisol) | 337.16 nmol/L | Standard Deviation 177.507 |
| 50 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Baseline (Testosterone) | 0.666 nmol/L | Standard Deviation 0.623 |
| 50 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Day 15 Change from Baseline (Testosterone) | 0.024 nmol/L | Standard Deviation 0.2578 |
| 50 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Day 15 Change from Baseline(Thyroxine) | -1.28 nmol/L | Standard Deviation 8.127 |
| 50 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Baseline(Triiodothyronine) | 2.060 nmol/L | Standard Deviation 0.3174 |
| 100 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Day 15 Change from Baseline (Cortisol) | 68.05 nmol/L | Standard Deviation 170.121 |
| 100 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Baseline(Triiodothyronine) | 1.980 nmol/L | Standard Deviation 0.2916 |
| 100 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Baseline (Cortisol) | 345.91 nmol/L | Standard Deviation 173.302 |
| 100 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Baseline(Thyroxine) | 96.11 nmol/L | Standard Deviation 14.645 |
| 100 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Day 15 Change from Baseline (Triiodothyronine) | -0.407 nmol/L | Standard Deviation 0.218 |
| 100 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Baseline (Testosterone) | 0.517 nmol/L | Standard Deviation 0.2317 |
| 100 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Day 15 Change from Baseline(Thyroxine) | -10.67 nmol/L | Standard Deviation 26.324 |
| 100 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Day 15 Change from Baseline (Testosterone) | 0.696 nmol/L | Standard Deviation 0.3367 |
| 150 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Day 15 Change from Baseline(Thyroxine) | 6.53 nmol/L | Standard Deviation 9.546 |
| 150 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Baseline (Cortisol) | 251.66 nmol/L | Standard Deviation 144.743 |
| 150 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Day 15 Change from Baseline (Testosterone) | 0.480 nmol/L | Standard Deviation 0.4589 |
| 150 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Baseline (Testosterone) | 0.433 nmol/L | Standard Deviation 0.2961 |
| 150 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Baseline(Thyroxine) | 86.41 nmol/L | Standard Deviation 16.116 |
| 150 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Baseline(Triiodothyronine) | 1.776 nmol/L | Standard Deviation 0.451 |
| 150 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Day 15 Change from Baseline (Cortisol) | 92.02 nmol/L | Standard Deviation 159.464 |
| 150 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Day 15 Change from Baseline (Triiodothyronine) | -0.148 nmol/L | Standard Deviation 0.1883 |
| 300 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Day 15 Change from Baseline (Cortisol) | 127.20 nmol/L | Standard Deviation 208.452 |
| 300 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Baseline (Testosterone) | 0.611 nmol/L | Standard Deviation 0.4271 |
| 300 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Baseline(Triiodothyronine) | 2.163 nmol/L | Standard Deviation 0.6008 |
| 300 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Day 15 Change from Baseline (Testosterone) | 0.524 nmol/L | Standard Deviation 0.2905 |
| 300 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Baseline(Thyroxine) | 94.16 nmol/L | Standard Deviation 22.18 |
| 300 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Day 15 Change from Baseline(Thyroxine) | 0.88 nmol/L | Standard Deviation 13.72 |
| 300 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Baseline (Cortisol) | 230.42 nmol/L | Standard Deviation 74.56 |
| 300 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Day 15 Change from Baseline (Triiodothyronine) | -0.416 nmol/L | Standard Deviation 0.5359 |
Primary
Change From Baseline at Day 15 for Laboratory Hormones Results: Follicle Stimulating Hormone
Blood samples for the assessment of Follicle Stimulating were collected upon participants admission to the unit.
Time frame: Baseline and day 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 15 for Laboratory Hormones Results: Follicle Stimulating Hormone | Baseline | 76.01 IU/L | Standard Deviation 23.122 |
| Placebo | Change From Baseline at Day 15 for Laboratory Hormones Results: Follicle Stimulating Hormone | Day 15 Change from Baseline | 5.98 IU/L | Standard Deviation 13.072 |
| 50 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results: Follicle Stimulating Hormone | Baseline | 100.87 IU/L | Standard Deviation 36.813 |
| 50 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results: Follicle Stimulating Hormone | Day 15 Change from Baseline | -2.29 IU/L | Standard Deviation 20.948 |
| 100 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results: Follicle Stimulating Hormone | Baseline | 77.78 IU/L | Standard Deviation 20.132 |
| 100 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results: Follicle Stimulating Hormone | Day 15 Change from Baseline | 4.09 IU/L | Standard Deviation 8.353 |
| 150 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results: Follicle Stimulating Hormone | Day 15 Change from Baseline | 6.73 IU/L | Standard Deviation 6.904 |
| 150 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results: Follicle Stimulating Hormone | Baseline | 88.77 IU/L | Standard Deviation 42.251 |
| 300 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results: Follicle Stimulating Hormone | Baseline | 70.59 IU/L | Standard Deviation 17.046 |
| 300 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results: Follicle Stimulating Hormone | Day 15 Change from Baseline | 8.92 IU/L | Standard Deviation 13.409 |
Primary
Change From Baseline at Day 15 for Laboratory Hormones Results: Thyrotropin
Blood samples for the assessment of Thyrotropin were collected upon participants admission to the unit.
Time frame: Baseline and day 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 15 for Laboratory Hormones Results: Thyrotropin | Baseline | 2.658 mIU/L | Standard Deviation 1.7584 |
| Placebo | Change From Baseline at Day 15 for Laboratory Hormones Results: Thyrotropin | Day 15 Change from Baseline | -0.959 mIU/L | Standard Deviation 1.3501 |
| 50 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results: Thyrotropin | Baseline | 1.800 mIU/L | Standard Deviation 0.983 |
| 50 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results: Thyrotropin | Day 15 Change from Baseline | -0.571 mIU/L | Standard Deviation 0.8148 |
| 100 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results: Thyrotropin | Baseline | 2.451 mIU/L | Standard Deviation 1.4811 |
| 100 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results: Thyrotropin | Day 15 Change from Baseline | -0.648 mIU/L | Standard Deviation 0.5903 |
| 150 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results: Thyrotropin | Day 15 Change from Baseline | -0.823 mIU/L | Standard Deviation 1.0604 |
| 150 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results: Thyrotropin | Baseline | 2.785 mIU/L | Standard Deviation 1.1449 |
| 300 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results: Thyrotropin | Baseline | 2.330 mIU/L | Standard Deviation 1.2658 |
| 300 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results: Thyrotropin | Day 15 Change from Baseline | -0.616 mIU/L | Standard Deviation 1.1375 |
Primary
Change From Baseline at Day 15 for Laboratory Hormones Results : Triiodothyronine Uptake
Blood samples for the assessment of Triiodothyronine were collected upon participants admission to the unit.
Time frame: Baseline and day 15
Population: Participants in PK analysis set with evaluable data for this outcome measure presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Day 15 for Laboratory Hormones Results : Triiodothyronine Uptake | Day 15 Change from Baseline | -0.720 Percentage of T Uptake | Standard Deviation 0.7662 |
| Placebo | Change From Baseline at Day 15 for Laboratory Hormones Results : Triiodothyronine Uptake | Baseline | 32.300 Percentage of T Uptake | Standard Deviation 3.5623 |
| 50 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Triiodothyronine Uptake | Baseline | 30.800 Percentage of T Uptake | Standard Deviation 2.4712 |
| 50 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Triiodothyronine Uptake | Day 15 Change from Baseline | -0.700 Percentage of T Uptake | Standard Deviation 0.2944 |
| 100 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Triiodothyronine Uptake | Day 15 Change from Baseline | 0.143 Percentage of T Uptake | Standard Deviation 0.7115 |
| 100 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Triiodothyronine Uptake | Baseline | 30.838 Percentage of T Uptake | Standard Deviation 1.7968 |
| 150 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Triiodothyronine Uptake | Baseline | 30.671 Percentage of T Uptake | Standard Deviation 1.306 |
| 150 mg BAY3427080 | Change From Baseline at Day 15 for Laboratory Hormones Results : Triiodothyronine Uptake | Day 15 Change from Baseline | 0.443 Percentage of T Uptake | Standard Deviation 1.013 |
Primary
Heart Rate (HR) - Change From Baseline (Day -1) at Day 14
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.
Time frame: Baseline (day -1) and day 14
Population: Participants with available data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1(Predose) | 65.7 beats/min | Standard Deviation 9.5 |
| Placebo | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | -0.4 beats/min | Standard Deviation 6.87 |
| Placebo | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 68.0 beats/min | Standard Deviation 10.5 |
| Placebo | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 77.0 beats/min | Standard Deviation 9.63 |
| Placebo | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 72.9 beats/min | Standard Deviation 10.38 |
| Placebo | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | -2.6 beats/min | Standard Deviation 7.58 |
| Placebo | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | -2.2 beats/min | Standard Deviation 6.22 |
| Placebo | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour) | 68.5 beats/min | Standard Deviation 9.54 |
| Placebo | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | -4.3 beats/min | Standard Deviation 8.57 |
| Placebo | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 69.8 beats/min | Standard Deviation 9.27 |
| Placebo | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | -4.9 beats/min | Standard Deviation 9.94 |
| Placebo | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | -4.2 beats/min | Standard Deviation 7.16 |
| Placebo | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 68.9 beats/min | Standard Deviation 9.26 |
| Placebo | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | -6.5 beats/min | Standard Deviation 10.98 |
| Placebo | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 70.2 beats/min | Standard Deviation 10.95 |
| Placebo | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | -5.5 beats/min | Standard Deviation 8.13 |
| Placebo | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 68.7 beats/min | Standard Deviation 9.02 |
| Placebo | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | -0.9 beats/min | Standard Deviation 5.7 |
| Placebo | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | -5.0 beats/min | Standard Deviation 8.66 |
| Placebo | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 69.4 beats/min | Standard Deviation 9.06 |
| 50 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | 0.7 beats/min | Standard Deviation 5.74 |
| 50 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | -0.3 beats/min | Standard Deviation 4.08 |
| 50 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | -10.5 beats/min | Standard Deviation 8.6 |
| 50 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | -7.4 beats/min | Standard Deviation 7.24 |
| 50 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 62.8 beats/min | Standard Deviation 6.7 |
| 50 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1(Predose) | 61.6 beats/min | Standard Deviation 6.43 |
| 50 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 68.7 beats/min | Standard Deviation 8.96 |
| 50 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 64.3 beats/min | Standard Deviation 4.91 |
| 50 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 67.3 beats/min | Standard Deviation 7.24 |
| 50 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 64.4 beats/min | Standard Deviation 5.95 |
| 50 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | -4.6 beats/min | Standard Deviation 5.05 |
| 50 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | 0.5 beats/min | Standard Deviation 5.15 |
| 50 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | -7.9 beats/min | Standard Deviation 7.98 |
| 50 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | -6.7 beats/min | Standard Deviation 9.65 |
| 50 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour) | 64.5 beats/min | Standard Deviation 8.76 |
| 50 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | -5.1 beats/min | Standard Deviation 8.48 |
| 50 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | -2.9 beats/min | Standard Deviation 4.83 |
| 50 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 69.4 beats/min | Standard Deviation 8.86 |
| 50 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 67.3 beats/min | Standard Deviation 7.81 |
| 50 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 66.8 beats/min | Standard Deviation 9.58 |
| 100 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 70.2 beats/min | Standard Deviation 10.68 |
| 100 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | 2.3 beats/min | Standard Deviation 8.26 |
| 100 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1(Predose) | 65.3 beats/min | Standard Deviation 8.43 |
| 100 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour) | 66.7 beats/min | Standard Deviation 10.56 |
| 100 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 66.2 beats/min | Standard Deviation 9.31 |
| 100 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 66.5 beats/min | Standard Deviation 9.09 |
| 100 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 65.9 beats/min | Standard Deviation 9.96 |
| 100 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 64.6 beats/min | Standard Deviation 10.11 |
| 100 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 65.6 beats/min | Standard Deviation 7.89 |
| 100 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 64.3 beats/min | Standard Deviation 6.2 |
| 100 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 73.6 beats/min | Standard Deviation 7.43 |
| 100 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | 0.8 beats/min | Standard Deviation 6.14 |
| 100 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | -0.9 beats/min | Standard Deviation 10.1 |
| 100 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | -0.6 beats/min | Standard Deviation 9.18 |
| 100 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | -1.5 beats/min | Standard Deviation 7.1 |
| 100 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | -2.4 beats/min | Standard Deviation 8.54 |
| 100 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | -0.3 beats/min | Standard Deviation 7.05 |
| 100 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | -0.4 beats/min | Standard Deviation 8.45 |
| 100 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | 0.2 beats/min | Standard Deviation 8.86 |
| 100 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | 6.8 beats/min | Standard Deviation 8.99 |
| 150 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | -2.1 beats/min | Standard Deviation 6.96 |
| 150 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | -4.3 beats/min | Standard Deviation 10.24 |
| 150 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 65.1 beats/min | Standard Deviation 4.19 |
| 150 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1(Predose) | 64.5 beats/min | Standard Deviation 5.85 |
| 150 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | -7.9 beats/min | Standard Deviation 8.35 |
| 150 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 65.2 beats/min | Standard Deviation 4.38 |
| 150 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | -7.9 beats/min | Standard Deviation 8.07 |
| 150 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 67.3 beats/min | Standard Deviation 5.38 |
| 150 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | 1.0 beats/min | Standard Deviation 6.47 |
| 150 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | -4.2 beats/min | Standard Deviation 7.9 |
| 150 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 67.6 beats/min | Standard Deviation 5.69 |
| 150 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | -4.2 beats/min | Standard Deviation 4.95 |
| 150 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | 0.0 beats/min | Standard Deviation 5.49 |
| 150 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | -7.5 beats/min | Standard Deviation 7.74 |
| 150 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour) | 66.1 beats/min | Standard Deviation 9.13 |
| 150 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 66.9 beats/min | Standard Deviation 7.17 |
| 150 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 63.9 beats/min | Standard Deviation 5.54 |
| 150 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | -2.0 beats/min | Standard Deviation 7.36 |
| 150 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 70.7 beats/min | Standard Deviation 7.81 |
| 150 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 67.9 beats/min | Standard Deviation 5.79 |
| 300 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 71.6 beats/min | Standard Deviation 8.69 |
| 300 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1(Predose) | 65.0 beats/min | Standard Deviation 7.16 |
| 300 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | -2.3 beats/min | Standard Deviation 9.4 |
| 300 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | -9.6 beats/min | Standard Deviation 10.13 |
| 300 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 68.2 beats/min | Standard Deviation 10.32 |
| 300 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 67.5 beats/min | Standard Deviation 8.4 |
| 300 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | -7.8 beats/min | Standard Deviation 10.48 |
| 300 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 68.8 beats/min | Standard Deviation 7.51 |
| 300 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | -7.7 beats/min | Standard Deviation 6.92 |
| 300 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 66.3 beats/min | Standard Deviation 8.36 |
| 300 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | -3.8 beats/min | Standard Deviation 8.85 |
| 300 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | -3.2 beats/min | Standard Deviation 9.57 |
| 300 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | -5.7 beats/min | Standard Deviation 9.94 |
| 300 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | -7.6 beats/min | Standard Deviation 8.08 |
| 300 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 67.5 beats/min | Standard Deviation 7.37 |
| 300 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour) | 68.7 beats/min | Standard Deviation 9.94 |
| 300 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | -5.8 beats/min | Standard Deviation 7.62 |
| 300 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 70.2 beats/min | Standard Deviation 8.14 |
| 300 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | -7.0 beats/min | Standard Deviation 6.94 |
| 300 mg BAY3427080 | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 67.2 beats/min | Standard Deviation 7.77 |
Primary
Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate African at Baseline
Blood samples for the assessment of Glomerular Filtration Rate African were collected upon participants admission to the unit.
Time frame: At Baseline
Population: Participants with available data reported. Baseline is the last available measurement prior to the first dose of study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate African at Baseline | 1.628 mL/sec/1.73m^2 | Standard Deviation 0.2347 |
| 50 mg BAY3427080 | Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate African at Baseline | 1.759 mL/sec/1.73m^2 | Standard Deviation 0.1592 |
| 100 mg BAY3427080 | Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate African at Baseline | 1.580 mL/sec/1.73m^2 | Standard Deviation 0.1846 |
| 150 mg BAY3427080 | Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate African at Baseline | 1.557 mL/sec/1.73m^2 | Standard Deviation 0.1553 |
| 300 mg BAY3427080 | Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate African at Baseline | 1.666 mL/sec/1.73m^2 | Standard Deviation 0.1885 |
Primary
Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate Caucasian at Baseline
Blood samples for the assessment of Glomerular Filtration Rate Caucasian were collected upon participants admission to the unit.
Time frame: At Baseline
Population: Participants with available data reported. Baseline is the last available measurement prior to the first dose of study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate Caucasian at Baseline | 1.343 mL/sec/1.73m^2 | Standard Deviation 0.1955 |
| 50 mg BAY3427080 | Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate Caucasian at Baseline | 1.450 mL/sec/1.73m^2 | Standard Deviation 0.1265 |
| 100 mg BAY3427080 | Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate Caucasian at Baseline | 1.300 mL/sec/1.73m^2 | Standard Deviation 0.1503 |
| 150 mg BAY3427080 | Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate Caucasian at Baseline | 1.290 mL/sec/1.73m^2 | Standard Deviation 0.1273 |
| 300 mg BAY3427080 | Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate Caucasian at Baseline | 1.378 mL/sec/1.73m^2 | Standard Deviation 0.1482 |
Primary
Maximum Observed Plasma Concentration (Cmax) of BAY3427080
Cmax is the maximum observed plasma concentration of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration.
Time frame: On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours)
Population: Participants who received placebo were not included in the PK population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| 50 mg BAY3427080 | Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | Day 1 | 502.62 ng/mL | Geometric Coefficient of Variation 90.19 |
| 50 mg BAY3427080 | Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | Day 14 | 522.36 ng/mL | Geometric Coefficient of Variation 87.88 |
| 50 mg BAY3427080 | Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | Day 7 | 548.60 ng/mL | Geometric Coefficient of Variation 57.47 |
| 100 mg BAY3427080 | Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | Day 1 | 731.69 ng/mL | Geometric Coefficient of Variation 110.58 |
| 100 mg BAY3427080 | Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | Day 14 | 841.42 ng/mL | Geometric Coefficient of Variation 107.16 |
| 100 mg BAY3427080 | Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | Day 7 | 809.48 ng/mL | Geometric Coefficient of Variation 116.58 |
| 150 mg BAY3427080 | Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | Day 7 | 1173.50 ng/mL | Geometric Coefficient of Variation 95.14 |
| 150 mg BAY3427080 | Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | Day 1 | 911.48 ng/mL | Geometric Coefficient of Variation 148.28 |
| 150 mg BAY3427080 | Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | Day 14 | 1188.19 ng/mL | Geometric Coefficient of Variation 131.2 |
| 300 mg BAY3427080 | Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | Day 1 | 1576.01 ng/mL | Geometric Coefficient of Variation 90.7 |
| 300 mg BAY3427080 | Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | Day 14 | 2851.83 ng/mL | Geometric Coefficient of Variation 116.53 |
| 300 mg BAY3427080 | Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | Day 7 | 2045.61 ng/mL | Geometric Coefficient of Variation 152.87 |
Primary
Mean PR Interval - Change From Baseline (Day -1) at 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.
Time frame: Baseline (day -1) and day 14
Population: Participants with available data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | 5.6 msec | Standard Deviation 12.32 |
| Placebo | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 162.1 msec | Standard Deviation 23.67 |
| Placebo | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | 5.6 msec | Standard Deviation 15.88 |
| Placebo | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 165.7 msec | Standard Deviation 26.9 |
| Placebo | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | 8.5 msec | Standard Deviation 20 |
| Placebo | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour) | 163.3 msec | Standard Deviation 24.69 |
| Placebo | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | -0.4 msec | Standard Deviation 8.83 |
| Placebo | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | 1.4 msec | Standard Deviation 8.66 |
| Placebo | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 166.3 msec | Standard Deviation 23.76 |
| Placebo | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (Predose) | 165.3 msec | Standard Deviation 22.2 |
| Placebo | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | 5.7 msec | Standard Deviation 15.13 |
| Placebo | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 166.9 msec | Standard Deviation 25.01 |
| Placebo | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | 3.8 msec | Standard Deviation 11.09 |
| Placebo | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 168.7 msec | Standard Deviation 26.32 |
| Placebo | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 167.6 msec | Standard Deviation 22.91 |
| Placebo | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | 2.2 msec | Standard Deviation 9.34 |
| Placebo | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 168.0 msec | Standard Deviation 25.66 |
| Placebo | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | 4.1 msec | Standard Deviation 12.56 |
| Placebo | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 165.6 msec | Standard Deviation 24.06 |
| Placebo | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | -1.0 msec | Standard Deviation 12.86 |
| 50 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 155.4 msec | Standard Deviation 17.27 |
| 50 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | 2.8 msec | Standard Deviation 9.03 |
| 50 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | 5.3 msec | Standard Deviation 11.4 |
| 50 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 152.5 msec | Standard Deviation 17.45 |
| 50 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | 1.7 msec | Standard Deviation 6.41 |
| 50 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | 0.6 msec | Standard Deviation 8.85 |
| 50 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | 0.4 msec | Standard Deviation 6.9 |
| 50 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 156.0 msec | Standard Deviation 18.95 |
| 50 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 157.7 msec | Standard Deviation 17.41 |
| 50 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | -3.6 msec | Standard Deviation 9.17 |
| 50 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (Predose) | 152.6 msec | Standard Deviation 14.3 |
| 50 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | -2.8 msec | Standard Deviation 9.59 |
| 50 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour) | 155.3 msec | Standard Deviation 20.19 |
| 50 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | 2.6 msec | Standard Deviation 13.33 |
| 50 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | 2.9 msec | Standard Deviation 5.95 |
| 50 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 153.7 msec | Standard Deviation 17.61 |
| 50 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 155.3 msec | Standard Deviation 18.32 |
| 50 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 158.9 msec | Standard Deviation 17.73 |
| 50 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | 1.4 msec | Standard Deviation 6.48 |
| 50 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 155.7 msec | Standard Deviation 20.43 |
| 100 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | 5.2 msec | Standard Deviation 20.77 |
| 100 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 166.6 msec | Standard Deviation 25.79 |
| 100 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (Predose) | 165.3 msec | Standard Deviation 26.1 |
| 100 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour) | 167.1 msec | Standard Deviation 26.74 |
| 100 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 165.9 msec | Standard Deviation 21.47 |
| 100 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 167.1 msec | Standard Deviation 22.27 |
| 100 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 165.8 msec | Standard Deviation 26.24 |
| 100 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 170.1 msec | Standard Deviation 31.39 |
| 100 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 165.1 msec | Standard Deviation 20.73 |
| 100 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 161.7 msec | Standard Deviation 22.93 |
| 100 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 158.5 msec | Standard Deviation 19.56 |
| 100 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | -1.8 msec | Standard Deviation 10.85 |
| 100 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | 0.9 msec | Standard Deviation 14.64 |
| 100 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | -1.0 msec | Standard Deviation 14.15 |
| 100 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | 3.9 msec | Standard Deviation 17.63 |
| 100 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | -0.9 msec | Standard Deviation 17.72 |
| 100 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | 0.0 msec | Standard Deviation 11.96 |
| 100 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | -3.1 msec | Standard Deviation 10.83 |
| 100 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | 0.1 msec | Standard Deviation 15.03 |
| 100 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | -0.1 msec | Standard Deviation 11.07 |
| 150 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 163.5 msec | Standard Deviation 25 |
| 150 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | -3.9 msec | Standard Deviation 12.21 |
| 150 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | 2.7 msec | Standard Deviation 19.24 |
| 150 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 163.6 msec | Standard Deviation 26.48 |
| 150 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | -0.5 msec | Standard Deviation 11.47 |
| 150 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 161.8 msec | Standard Deviation 23.66 |
| 150 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | 0.9 msec | Standard Deviation 11.82 |
| 150 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 165.2 msec | Standard Deviation 26.51 |
| 150 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (Predose) | 166.6 msec | Standard Deviation 26.74 |
| 150 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | 1.8 msec | Standard Deviation 12.11 |
| 150 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 164.9 msec | Standard Deviation 25.23 |
| 150 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | 4.5 msec | Standard Deviation 15.01 |
| 150 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 164.9 msec | Standard Deviation 26.07 |
| 150 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 166.5 msec | Standard Deviation 24.32 |
| 150 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | 1.8 msec | Standard Deviation 14.49 |
| 150 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour) | 162.1 msec | Standard Deviation 22.13 |
| 150 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | -0.3 msec | Standard Deviation 9.42 |
| 150 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 159.0 msec | Standard Deviation 21.78 |
| 150 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | 2.0 msec | Standard Deviation 9.33 |
| 150 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | 4.6 msec | Standard Deviation 12.49 |
| 300 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour) | 162.4 msec | Standard Deviation 20.59 |
| 300 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 161.6 msec | Standard Deviation 16.78 |
| 300 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 162.4 msec | Standard Deviation 17.6 |
| 300 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | 0.9 msec | Standard Deviation 10.8 |
| 300 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | 1.7 msec | Standard Deviation 13.74 |
| 300 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 156.5 msec | Standard Deviation 17.71 |
| 300 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 160.1 msec | Standard Deviation 20.1 |
| 300 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | 5.2 msec | Standard Deviation 6.54 |
| 300 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | 4.9 msec | Standard Deviation 14.78 |
| 300 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | 1.8 msec | Standard Deviation 17.08 |
| 300 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | -0.8 msec | Standard Deviation 13.9 |
| 300 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 160.4 msec | Standard Deviation 21.99 |
| 300 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (Predose) | 162.6 msec | Standard Deviation 20.52 |
| 300 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 162.1 msec | Standard Deviation 19.82 |
| 300 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | 4.2 msec | Standard Deviation 14.32 |
| 300 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 156.4 msec | Standard Deviation 16.6 |
| 300 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 162.9 msec | Standard Deviation 21.16 |
| 300 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | 0.9 msec | Standard Deviation 12.78 |
| 300 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | 2.2 msec | Standard Deviation 9.05 |
| 300 mg BAY3427080 | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | 8.3 msec | Standard Deviation 15.96 |
Primary
Mean QRS Duration - Change From Baseline (Day -1) at 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.
Time frame: Baseline (day -1) and day 14
Population: Participants with available data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | 1.9 msec | Standard Deviation 6.27 |
| Placebo | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | 2.2 msec | Standard Deviation 5.41 |
| Placebo | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | 1.7 msec | Standard Deviation 7.13 |
| Placebo | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | -0.8 msec | Standard Deviation 6 |
| Placebo | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | 1.0 msec | Standard Deviation 7.64 |
| Placebo | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | 1.7 msec | Standard Deviation 8.08 |
| Placebo | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 85.4 msec | Standard Deviation 11.26 |
| Placebo | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1(Predose) | 88.8 msec | Standard Deviation 10.82 |
| Placebo | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | -0.7 msec | Standard Deviation 3.63 |
| Placebo | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 86.2 msec | Standard Deviation 11.68 |
| Placebo | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 86.4 msec | Standard Deviation 10.1 |
| Placebo | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 87.6 msec | Standard Deviation 12.27 |
| Placebo | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour | 88.7 msec | Standard Deviation 10.44 |
| Placebo | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 86.6 msec | Standard Deviation 10.53 |
| Placebo | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 86.4 msec | Standard Deviation 11.08 |
| Placebo | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 89.4 msec | Standard Deviation 11.77 |
| Placebo | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | -1.7 msec | Standard Deviation 6.91 |
| Placebo | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 88.7 msec | Standard Deviation 10.22 |
| Placebo | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | 0.7 msec | Standard Deviation 6.66 |
| Placebo | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | -0.3 msec | Standard Deviation 3.82 |
| 50 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | 1.5 msec | Standard Deviation 6.83 |
| 50 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | 0.0 msec | Standard Deviation 3.57 |
| 50 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1(Predose) | 93.6 msec | Standard Deviation 8.11 |
| 50 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour | 94.5 msec | Standard Deviation 7.94 |
| 50 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 93.3 msec | Standard Deviation 7.17 |
| 50 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 91.7 msec | Standard Deviation 8.52 |
| 50 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | 3.2 msec | Standard Deviation 5.87 |
| 50 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | 0.9 msec | Standard Deviation 4.96 |
| 50 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | 0.5 msec | Standard Deviation 4.87 |
| 50 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | 0.5 msec | Standard Deviation 4.61 |
| 50 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | 1.5 msec | Standard Deviation 4.63 |
| 50 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | 0.3 msec | Standard Deviation 2.85 |
| 50 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 90.5 msec | Standard Deviation 7.98 |
| 50 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 91.5 msec | Standard Deviation 8.94 |
| 50 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 92.7 msec | Standard Deviation 6.94 |
| 50 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 92.3 msec | Standard Deviation 8.26 |
| 50 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 90.9 msec | Standard Deviation 9.16 |
| 50 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 92.0 msec | Standard Deviation 7.93 |
| 50 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | 0.3 msec | Standard Deviation 3.89 |
| 50 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | -1.2 msec | Standard Deviation 5.87 |
| 100 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 85.0 msec | Standard Deviation 7.98 |
| 100 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1(Predose) | 84.7 msec | Standard Deviation 6.39 |
| 100 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour | 87.4 msec | Standard Deviation 8.44 |
| 100 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 85.2 msec | Standard Deviation 7.94 |
| 100 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 84.0 msec | Standard Deviation 5.83 |
| 100 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 85.5 msec | Standard Deviation 9.13 |
| 100 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 85.7 msec | Standard Deviation 9.32 |
| 100 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | -0.8 msec | Standard Deviation 4.56 |
| 100 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | -3.1 msec | Standard Deviation 5.37 |
| 100 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 84.4 msec | Standard Deviation 8.22 |
| 100 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | 0.4 msec | Standard Deviation 3.41 |
| 100 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | -2.5 msec | Standard Deviation 6.44 |
| 100 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | -2.0 msec | Standard Deviation 6.26 |
| 100 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | -1.5 msec | Standard Deviation 6.56 |
| 100 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 81.1 msec | Standard Deviation 4.41 |
| 100 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | -3.3 msec | Standard Deviation 9.28 |
| 100 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | 0.4 msec | Standard Deviation 7.02 |
| 100 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | -1.6 msec | Standard Deviation 7.46 |
| 100 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 85.1 msec | Standard Deviation 9.68 |
| 100 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | -0.8 msec | Standard Deviation 5.25 |
| 150 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 85.4 msec | Standard Deviation 11.79 |
| 150 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | -1.5 msec | Standard Deviation 7.06 |
| 150 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 90.3 msec | Standard Deviation 9.91 |
| 150 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | 14.8 msec | Standard Deviation 49.01 |
| 150 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 86.3 msec | Standard Deviation 10.55 |
| 150 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | 0.9 msec | Standard Deviation 6.26 |
| 150 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | -0.5 msec | Standard Deviation 5.49 |
| 150 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour | 88.5 msec | Standard Deviation 10.86 |
| 150 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | 0.4 msec | Standard Deviation 6.53 |
| 150 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 89.5 msec | Standard Deviation 11.15 |
| 150 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 89.0 msec | Standard Deviation 10.27 |
| 150 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1(Predose) | 89.2 msec | Standard Deviation 10.99 |
| 150 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 88.6 msec | Standard Deviation 10.1 |
| 150 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | -0.1 msec | Standard Deviation 6.71 |
| 150 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 87.7 msec | Standard Deviation 11.04 |
| 150 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | 3.4 msec | Standard Deviation 6.74 |
| 150 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | 1.9 msec | Standard Deviation 8.34 |
| 150 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | 1.2 msec | Standard Deviation 5.61 |
| 150 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | -0.1 msec | Standard Deviation 8.88 |
| 150 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 89.5 msec | Standard Deviation 10.2 |
| 300 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | 2.8 msec | Standard Deviation 5.06 |
| 300 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 88.7 msec | Standard Deviation 11.53 |
| 300 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | -0.8 msec | Standard Deviation 7.69 |
| 300 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | 3.1 msec | Standard Deviation 7.8 |
| 300 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 88.1 msec | Standard Deviation 13.08 |
| 300 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour | 88.9 msec | Standard Deviation 10.73 |
| 300 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | 2.6 msec | Standard Deviation 8.9 |
| 300 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | -1.8 msec | Standard Deviation 8.62 |
| 300 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | 2.5 msec | Standard Deviation 6.05 |
| 300 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 85.3 msec | Standard Deviation 11.46 |
| 300 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | 1.7 msec | Standard Deviation 7.8 |
| 300 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 87.8 msec | Standard Deviation 10.8 |
| 300 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | 3.4 msec | Standard Deviation 7.39 |
| 300 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1(Predose) | 89.5 msec | Standard Deviation 11.76 |
| 300 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 89.0 msec | Standard Deviation 10.04 |
| 300 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | 1.0 msec | Standard Deviation 8.08 |
| 300 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 87.9 msec | Standard Deviation 11.06 |
| 300 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 92.2 msec | Standard Deviation 11.59 |
| 300 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | -2.5 msec | Standard Deviation 10.73 |
| 300 mg BAY3427080 | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 91.2 msec | Standard Deviation 13.04 |
Primary
Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at 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.
Time frame: Baseline (day -1) and day 14
Population: Participants with available data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | 0.4 msec | Standard Deviation 13.21 |
| Placebo | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 437.0 msec | Standard Deviation 14.34 |
| Placebo | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 441.3 msec | Standard Deviation 22.48 |
| Placebo | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 438.3 msec | Standard Deviation 13.91 |
| Placebo | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | -6.7 msec | Standard Deviation 14.73 |
| Placebo | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (Predose) | 438.6 msec | Standard Deviation 18.07 |
| Placebo | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 442.8 msec | Standard Deviation 17.55 |
| Placebo | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | -1.6 msec | Standard Deviation 13.9 |
| Placebo | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | -5.9 msec | Standard Deviation 19.59 |
| Placebo | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | 0.3 msec | Standard Deviation 15.11 |
| Placebo | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 437.8 msec | Standard Deviation 21.87 |
| Placebo | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | -8.0 msec | Standard Deviation 16.86 |
| Placebo | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | -4.4 msec | Standard Deviation 12.46 |
| Placebo | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 438.1 msec | Standard Deviation 21.09 |
| Placebo | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | -3.4 msec | Standard Deviation 23.12 |
| Placebo | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour) | 438.1 msec | Standard Deviation 16.29 |
| Placebo | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | -5.7 msec | Standard Deviation 24.18 |
| Placebo | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 436.6 msec | Standard Deviation 18.42 |
| Placebo | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 431.6 msec | Standard Deviation 18.31 |
| Placebo | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | -6.1 msec | Standard Deviation 16.42 |
| 50 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | -0.8 msec | Standard Deviation 13.48 |
| 50 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | -5.7 msec | Standard Deviation 22.17 |
| 50 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 424.2 msec | Standard Deviation 17.81 |
| 50 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 428.3 msec | Standard Deviation 16.51 |
| 50 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (Predose) | 430.7 msec | Standard Deviation 18.1 |
| 50 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 431.3 msec | Standard Deviation 20.62 |
| 50 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 423.4 msec | Standard Deviation 21.21 |
| 50 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 433.4 msec | Standard Deviation 16.01 |
| 50 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | 0.0 msec | Standard Deviation 21 |
| 50 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | 2.1 msec | Standard Deviation 13.19 |
| 50 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | 1.9 msec | Standard Deviation 20.81 |
| 50 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | -4.6 msec | Standard Deviation 19.55 |
| 50 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | -0.3 msec | Standard Deviation 13.93 |
| 50 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 425.7 msec | Standard Deviation 22.43 |
| 50 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | -0.1 msec | Standard Deviation 15.1 |
| 50 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 432.1 msec | Standard Deviation 22.47 |
| 50 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour) | 435.6 msec | Standard Deviation 21.78 |
| 50 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | -8.9 msec | Standard Deviation 17.34 |
| 50 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | 3.3 msec | Standard Deviation 17.73 |
| 50 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 435.3 msec | Standard Deviation 18.84 |
| 100 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | -5.5 msec | Standard Deviation 13.67 |
| 100 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | 2.2 msec | Standard Deviation 15.76 |
| 100 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | -8.9 msec | Standard Deviation 13.33 |
| 100 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 433.7 msec | Standard Deviation 18.9 |
| 100 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | -5.5 msec | Standard Deviation 10.36 |
| 100 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (Predose) | 427.6 msec | Standard Deviation 13.14 |
| 100 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | -2.9 msec | Standard Deviation 19.35 |
| 100 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | 5.5 msec | Standard Deviation 19.09 |
| 100 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 427.4 msec | Standard Deviation 18.56 |
| 100 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 426.6 msec | Standard Deviation 17.12 |
| 100 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | -7.5 msec | Standard Deviation 16.64 |
| 100 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 422.7 msec | Standard Deviation 19.67 |
| 100 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | -4.2 msec | Standard Deviation 12.68 |
| 100 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 426.7 msec | Standard Deviation 16.74 |
| 100 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 424.6 msec | Standard Deviation 15.43 |
| 100 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour) | 429.1 msec | Standard Deviation 19.47 |
| 100 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 425.9 msec | Standard Deviation 21.39 |
| 100 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | -0.4 msec | Standard Deviation 11.01 |
| 100 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 436.4 msec | Standard Deviation 9.44 |
| 100 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | -6.9 msec | Standard Deviation 14.02 |
| 150 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | 1.9 msec | Standard Deviation 13.13 |
| 150 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (Predose) | 436.1 msec | Standard Deviation 17.61 |
| 150 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour) | 436.5 msec | Standard Deviation 20.61 |
| 150 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 439.4 msec | Standard Deviation 16.23 |
| 150 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 438.5 msec | Standard Deviation 15.28 |
| 150 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 430.3 msec | Standard Deviation 16.49 |
| 150 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 435.9 msec | Standard Deviation 18.04 |
| 150 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 435.5 msec | Standard Deviation 13.93 |
| 150 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 430.3 msec | Standard Deviation 14.06 |
| 150 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 427.1 msec | Standard Deviation 18.11 |
| 150 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 434.9 msec | Standard Deviation 20.98 |
| 150 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | -8.9 msec | Standard Deviation 25.9 |
| 150 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | -3.4 msec | Standard Deviation 19.47 |
| 150 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | -10.3 msec | Standard Deviation 23.07 |
| 150 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | -11.1 msec | Standard Deviation 18.95 |
| 150 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | -1.4 msec | Standard Deviation 17.37 |
| 150 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | -6.3 msec | Standard Deviation 12.49 |
| 150 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | -2.2 msec | Standard Deviation 16.13 |
| 150 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | -0.9 msec | Standard Deviation 14.17 |
| 150 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | -1.2 msec | Standard Deviation 20.57 |
| 300 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | -0.2 msec | Standard Deviation 24.65 |
| 300 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | -10.8 msec | Standard Deviation 16.97 |
| 300 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | -8.5 msec | Standard Deviation 17.83 |
| 300 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 428.8 msec | Standard Deviation 17.99 |
| 300 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 429.5 msec | Standard Deviation 27.28 |
| 300 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour) | 431.8 msec | Standard Deviation 20.32 |
| 300 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | -0.7 msec | Standard Deviation 14.57 |
| 300 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 431.2 msec | Standard Deviation 26 |
| 300 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 428.4 msec | Standard Deviation 19.4 |
| 300 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 436.9 msec | Standard Deviation 21.27 |
| 300 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (Predose) | 417.3 msec | Standard Deviation 25.91 |
| 300 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | -0.1 msec | Standard Deviation 27.06 |
| 300 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 432.1 msec | Standard Deviation 18.48 |
| 300 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 436.0 msec | Standard Deviation 16.65 |
| 300 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 428.8 msec | Standard Deviation 15.65 |
| 300 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | -0.2 msec | Standard Deviation 18.66 |
| 300 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | -7.5 msec | Standard Deviation 16.37 |
| 300 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | -8.5 msec | Standard Deviation 19.32 |
| 300 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | -7.5 msec | Standard Deviation 16.25 |
| 300 mg BAY3427080 | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | -10.3 msec | Standard Deviation 17.32 |
Primary
Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at 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.
Time frame: Baseline (day -1) and day 14
Population: Participants with available data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | 1.1 msec | Standard Deviation 20.94 |
| Placebo | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 426.7 msec | Standard Deviation 16.64 |
| Placebo | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 428.7 msec | Standard Deviation 19.29 |
| Placebo | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 427.2 msec | Standard Deviation 17.33 |
| Placebo | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 423.4 msec | Standard Deviation 19.52 |
| Placebo | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | -2.6 msec | Standard Deviation 11.94 |
| Placebo | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | -3.0 msec | Standard Deviation 14.97 |
| Placebo | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | -6.6 msec | Standard Deviation 11.74 |
| Placebo | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour) | 429.2 msec | Standard Deviation 16.14 |
| Placebo | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | 0.1 msec | Standard Deviation 13.97 |
| Placebo | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 421.2 msec | Standard Deviation 16.25 |
| Placebo | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 423.8 msec | Standard Deviation 16.12 |
| Placebo | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | 1.2 msec | Standard Deviation 14.43 |
| Placebo | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 432.2 msec | Standard Deviation 14.68 |
| Placebo | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1(Predose) | 432.7 msec | Standard Deviation 18.75 |
| Placebo | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | -2.0 msec | Standard Deviation 9.55 |
| Placebo | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | 4.6 msec | Standard Deviation 11.77 |
| Placebo | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | 3.6 msec | Standard Deviation 13.91 |
| Placebo | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 431.7 msec | Standard Deviation 18.47 |
| Placebo | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | 1.3 msec | Standard Deviation 17.4 |
| 50 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 420.5 msec | Standard Deviation 13.47 |
| 50 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1(Predose) | 429.0 msec | Standard Deviation 16.87 |
| 50 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour) | 430.9 msec | Standard Deviation 18.81 |
| 50 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 428.3 msec | Standard Deviation 14.85 |
| 50 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 423.4 msec | Standard Deviation 17.6 |
| 50 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 422.1 msec | Standard Deviation 21.46 |
| 50 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 420.3 msec | Standard Deviation 18.14 |
| 50 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 420.3 msec | Standard Deviation 18.14 |
| 50 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | 5.9 msec | Standard Deviation 18.24 |
| 50 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | 7.0 msec | Standard Deviation 17.29 |
| 50 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | 7.1 msec | Standard Deviation 14.96 |
| 50 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | -1.1 msec | Standard Deviation 10.67 |
| 50 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | 1.3 msec | Standard Deviation 10.33 |
| 50 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 419.3 msec | Standard Deviation 15.99 |
| 50 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 424.2 msec | Standard Deviation 13.91 |
| 50 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | 0.3 msec | Standard Deviation 12.75 |
| 50 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | -2.9 msec | Standard Deviation 9.31 |
| 50 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | 2.7 msec | Standard Deviation 11.08 |
| 50 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | 8.3 msec | Standard Deviation 15.45 |
| 50 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | 8.7 msec | Standard Deviation 11.48 |
| 100 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 420.9 msec | Standard Deviation 15.57 |
| 100 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 420.6 msec | Standard Deviation 14.81 |
| 100 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | 2.3 msec | Standard Deviation 13.84 |
| 100 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | 0.3 msec | Standard Deviation 7.71 |
| 100 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | -3.8 msec | Standard Deviation 11.34 |
| 100 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 427.3 msec | Standard Deviation 16.15 |
| 100 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | -1.3 msec | Standard Deviation 13.74 |
| 100 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | -3.8 msec | Standard Deviation 9.02 |
| 100 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | -9.4 msec | Standard Deviation 13.78 |
| 100 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 415.5 msec | Standard Deviation 17.53 |
| 100 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour) | 422.3 msec | Standard Deviation 14.4 |
| 100 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 422.1 msec | Standard Deviation 11.25 |
| 100 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | -7.9 msec | Standard Deviation 13.31 |
| 100 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | -4.4 msec | Standard Deviation 10.52 |
| 100 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1(Predose) | 422.3 msec | Standard Deviation 14.41 |
| 100 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 418.3 msec | Standard Deviation 17.41 |
| 100 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | -0.4 msec | Standard Deviation 15.25 |
| 100 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 419.9 msec | Standard Deviation 15.56 |
| 100 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | -8.4 msec | Standard Deviation 12.88 |
| 100 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 419.9 msec | Standard Deviation 14.74 |
| 150 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1(Predose) | 431.1 msec | Standard Deviation 17.28 |
| 150 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | -2.1 msec | Standard Deviation 15.16 |
| 150 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 429.9 msec | Standard Deviation 18.39 |
| 150 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | -1.2 msec | Standard Deviation 18.18 |
| 150 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 430.5 msec | Standard Deviation 15.73 |
| 150 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | 3.8 msec | Standard Deviation 16.62 |
| 150 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 423.7 msec | Standard Deviation 20.16 |
| 150 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 427.0 msec | Standard Deviation 15.46 |
| 150 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 419.7 msec | Standard Deviation 16.65 |
| 150 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | 1.1 msec | Standard Deviation 14.51 |
| 150 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 430.9 msec | Standard Deviation 16.46 |
| 150 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | 2.2 msec | Standard Deviation 12.14 |
| 150 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | -1.3 msec | Standard Deviation 17.43 |
| 150 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | 0.1 msec | Standard Deviation 15.55 |
| 150 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | -6.6 msec | Standard Deviation 22.83 |
| 150 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 426.2 msec | Standard Deviation 13.33 |
| 150 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | 6.7 msec | Standard Deviation 10.09 |
| 150 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 424.5 msec | Standard Deviation 16.55 |
| 150 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | -1.8 msec | Standard Deviation 14.03 |
| 150 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour) | 430.1 msec | Standard Deviation 16.21 |
| 300 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | 2.0 msec | Standard Deviation 22.2 |
| 300 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 425.2 msec | Standard Deviation 15.08 |
| 300 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 427.6 msec | Standard Deviation 15.24 |
| 300 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | 2.8 msec | Standard Deviation 17.21 |
| 300 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 418.8 msec | Standard Deviation 25.31 |
| 300 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 419.0 msec | Standard Deviation 17.83 |
| 300 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | 0.6 msec | Standard Deviation 15.77 |
| 300 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 416.8 msec | Standard Deviation 20.1 |
| 300 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1(Predose) | 421.8 msec | Standard Deviation 20.02 |
| 300 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 428.3 msec | Standard Deviation 17.29 |
| 300 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | -3.8 msec | Standard Deviation 13.46 |
| 300 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 423.2 msec | Standard Deviation 19.46 |
| 300 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | 0.8 msec | Standard Deviation 12.58 |
| 300 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | -2.3 msec | Standard Deviation 12.11 |
| 300 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 420.8 msec | Standard Deviation 13.55 |
| 300 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | 1.6 msec | Standard Deviation 15.34 |
| 300 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | 5.5 msec | Standard Deviation 15.08 |
| 300 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | 0.4 msec | Standard Deviation 12.92 |
| 300 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | 6.2 msec | Standard Deviation 22.76 |
| 300 mg BAY3427080 | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour) | 422.6 msec | Standard Deviation 15.35 |
Primary
Mean QT Interval - Change From Baseline (Day -1) at 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.
Time frame: Baseline (day -1) and day 14
Population: Participants with available data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | 14.2 msec | Standard Deviation 28.9 |
| Placebo | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | 11.7 msec | Standard Deviation 22.95 |
| Placebo | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 412.6 msec | Standard Deviation 22.81 |
| Placebo | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | 9.5 msec | Standard Deviation 25.18 |
| Placebo | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 408.3 msec | Standard Deviation 32.47 |
| Placebo | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour | 412.4 msec | Standard Deviation 27.58 |
| Placebo | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | 14.2 msec | Standard Deviation 25.19 |
| Placebo | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | 3.0 msec | Standard Deviation 17.62 |
| Placebo | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | -6.8 msec | Standard Deviation 17.03 |
| Placebo | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | 2.4 msec | Standard Deviation 14.71 |
| Placebo | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 411.3 msec | Standard Deviation 27.1 |
| Placebo | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 413.7 msec | Standard Deviation 23.6 |
| Placebo | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | 2.3 msec | Standard Deviation 17.73 |
| Placebo | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 407.8 msec | Standard Deviation 25.47 |
| Placebo | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 398.9 msec | Standard Deviation 29.1 |
| Placebo | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 407.4 msec | Standard Deviation 25.64 |
| Placebo | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | 6.9 msec | Standard Deviation 18.73 |
| Placebo | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (Predose) | 421.8 msec | Standard Deviation 31.07 |
| Placebo | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | 12.6 msec | Standard Deviation 22.9 |
| Placebo | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 389.2 msec | Standard Deviation 28.4 |
| 50 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | 8.7 msec | Standard Deviation 13.13 |
| 50 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour | 422.0 msec | Standard Deviation 24 |
| 50 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 414.6 msec | Standard Deviation 21.41 |
| 50 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 405.8 msec | Standard Deviation 19.18 |
| 50 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 408.4 msec | Standard Deviation 19.91 |
| 50 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | 17.8 msec | Standard Deviation 15.93 |
| 50 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | 24.5 msec | Standard Deviation 14.95 |
| 50 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 414.9 msec | Standard Deviation 20.19 |
| 50 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | 25.5 msec | Standard Deviation 18.13 |
| 50 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | 28.3 msec | Standard Deviation 22.66 |
| 50 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | 0.2 msec | Standard Deviation 15.11 |
| 50 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | 17.4 msec | Standard Deviation 15.42 |
| 50 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 411.9 msec | Standard Deviation 22.8 |
| 50 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | 13.5 msec | Standard Deviation 15.04 |
| 50 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 407.1 msec | Standard Deviation 22.55 |
| 50 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | -1.9 msec | Standard Deviation 12.65 |
| 50 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 410.3 msec | Standard Deviation 19.54 |
| 50 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | -0.8 msec | Standard Deviation 13.58 |
| 50 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (Predose) | 426.4 msec | Standard Deviation 23.73 |
| 50 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 403.4 msec | Standard Deviation 27.7 |
| 100 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour | 410.1 msec | Standard Deviation 29.29 |
| 100 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | -7.9 msec | Standard Deviation 28.71 |
| 100 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | -12.9 msec | Standard Deviation 18.71 |
| 100 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | -2.8 msec | Standard Deviation 23.91 |
| 100 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 410.7 msec | Standard Deviation 33.4 |
| 100 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 408.0 msec | Standard Deviation 23.71 |
| 100 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 395.5 msec | Standard Deviation 22.33 |
| 100 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (Predose) | 412.6 msec | Standard Deviation 29.12 |
| 100 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | -14.2 msec | Standard Deviation 18.23 |
| 100 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | 3.6 msec | Standard Deviation 25.04 |
| 100 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 396.3 msec | Standard Deviation 26.84 |
| 100 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | -0.5 msec | Standard Deviation 19.09 |
| 100 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | -2.4 msec | Standard Deviation 23.9 |
| 100 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | 1.4 msec | Standard Deviation 24.51 |
| 100 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 410.9 msec | Standard Deviation 32.1 |
| 100 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 409.9 msec | Standard Deviation 24.92 |
| 100 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 411.2 msec | Standard Deviation 21.83 |
| 100 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 415.6 msec | Standard Deviation 29.17 |
| 100 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | 1.9 msec | Standard Deviation 18.66 |
| 100 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | -9.6 msec | Standard Deviation 20.16 |
| 150 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 405.7 msec | Standard Deviation 22.57 |
| 150 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 402.2 msec | Standard Deviation 26.39 |
| 150 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | -2.1 msec | Standard Deviation 24.54 |
| 150 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | 10.2 msec | Standard Deviation 25.32 |
| 150 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | 16.3 msec | Standard Deviation 20.43 |
| 150 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | 15.7 msec | Standard Deviation 21.82 |
| 150 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | 16.3 msec | Standard Deviation 20.76 |
| 150 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | 12.9 msec | Standard Deviation 21.11 |
| 150 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | 18.3 msec | Standard Deviation 23.65 |
| 150 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | 5.5 msec | Standard Deviation 23.97 |
| 150 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | -3.7 msec | Standard Deviation 20.76 |
| 150 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | -1.8 msec | Standard Deviation 16.37 |
| 150 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (Predose) | 421.8 msec | Standard Deviation 22.12 |
| 150 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour | 417.7 msec | Standard Deviation 22.13 |
| 150 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 414.8 msec | Standard Deviation 21.32 |
| 150 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 414.9 msec | Standard Deviation 21.19 |
| 150 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 413.4 msec | Standard Deviation 20.2 |
| 150 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 418.9 msec | Standard Deviation 32.1 |
| 150 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 410.7 msec | Standard Deviation 23.04 |
| 150 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 418.1 msec | Standard Deviation 19.01 |
| 300 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (2 hour) | 412.7 msec | Standard Deviation 22.32 |
| 300 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (Predose) | 411.3 msec | Standard Deviation 16.01 |
| 300 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (12 hour) Change from Baseline | 7.8 msec | Standard Deviation 24.27 |
| 300 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (8 hour) Change from Baseline | 6.6 msec | Standard Deviation 27.45 |
| 300 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (Pre dose) Change from Baseline | 5.5 msec | Standard Deviation 21.03 |
| 300 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (2.5 hour) | 412.4 msec | Standard Deviation 26.3 |
| 300 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (4 hour) Change from Baseline | 18.3 msec | Standard Deviation 22.05 |
| 300 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (3 hour) Change from Baseline | 17.8 msec | Standard Deviation 28.64 |
| 300 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (2.5 hour) Change from Baseline | 14.0 msec | Standard Deviation 23.04 |
| 300 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (12 hour) | 394.4 msec | Standard Deviation 28.85 |
| 300 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (3 hour) | 401.2 msec | Standard Deviation 23.18 |
| 300 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (2 hour) Change from Baseline | 16.2 msec | Standard Deviation 16.67 |
| 300 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (1.5 hour) Change from Baseline | 17.5 msec | Standard Deviation 21.8 |
| 300 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (1 hour) Change from Baseline | 17.8 msec | Standard Deviation 22.08 |
| 300 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (8 hour) | 398.5 msec | Standard Deviation 27.65 |
| 300 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (4 hour) | 407.8 msec | Standard Deviation 16.98 |
| 300 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (1.5 hour) | 412.3 msec | Standard Deviation 22.31 |
| 300 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (1 hour) | 406.5 msec | Standard Deviation 21.2 |
| 300 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day -1 (0.5 hour | 405.6 msec | Standard Deviation 22.19 |
| 300 mg BAY3427080 | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | Day 14 (0.5 hour) Change from Baseline | 20.8 msec | Standard Deviation 24.94 |
Primary
Nature and Severity of Adverse Events (AEs) up to Day 21
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.
Time frame: On or after first drug administration up to end of study (Day 21).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any TEAE of Dehydration | 0 Participants |
| Placebo | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Life Threatening Serious TEAE | 0 Participants |
| Placebo | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any TEAE | 13 Participants |
| Placebo | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Severe TEAE | 0 Participants |
| Placebo | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Death | 0 Participants |
| Placebo | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any serious TEAE | 9 Participants |
| Placebo | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Mild TEAE | 12 Participants |
| Placebo | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Causally Related TEAE | 9 Participants |
| Placebo | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Moderate TEAE | 1 Participants |
| Placebo | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Causally Related Serious TEAE | 11 Participants |
| 50 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Death | 0 Participants |
| 50 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Severe TEAE | 0 Participants |
| 50 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Mild TEAE | 7 Participants |
| 50 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any serious TEAE | 7 Participants |
| 50 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Causally Related Serious TEAE | 0 Participants |
| 50 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Moderate TEAE | 1 Participants |
| 50 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any TEAE of Dehydration | 0 Participants |
| 50 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Causally Related TEAE | 7 Participants |
| 50 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any TEAE | 7 Participants |
| 50 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Life Threatening Serious TEAE | 0 Participants |
| 100 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Moderate TEAE | 1 Participants |
| 100 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Causally Related TEAE | 7 Participants |
| 100 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Severe TEAE | 0 Participants |
| 100 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Life Threatening Serious TEAE | 0 Participants |
| 100 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Causally Related Serious TEAE | 0 Participants |
| 100 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any TEAE of Dehydration | 0 Participants |
| 100 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Mild TEAE | 10 Participants |
| 100 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any serious TEAE | 7 Participants |
| 100 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any TEAE | 11 Participants |
| 100 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Death | 0 Participants |
| 150 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any TEAE of Dehydration | 0 Participants |
| 150 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Mild TEAE | 10 Participants |
| 150 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Moderate TEAE | 1 Participants |
| 150 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Severe TEAE | 0 Participants |
| 150 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any serious TEAE | 5 Participants |
| 150 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Causally Related TEAE | 5 Participants |
| 150 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Causally Related Serious TEAE | 0 Participants |
| 150 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any TEAE | 10 Participants |
| 150 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Life Threatening Serious TEAE | 0 Participants |
| 150 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Death | 0 Participants |
| 300 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Causally Related Serious TEAE | 0 Participants |
| 300 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any TEAE | 11 Participants |
| 300 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Causally Related TEAE | 11 Participants |
| 300 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any serious TEAE | 11 Participants |
| 300 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any TEAE of Dehydration | 0 Participants |
| 300 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Severe TEAE | 0 Participants |
| 300 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Moderate TEAE | 1 Participants |
| 300 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Mild TEAE | 11 Participants |
| 300 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Death | 0 Participants |
| 300 mg BAY3427080 | Nature and Severity of Adverse Events (AEs) up to Day 21 | Any Life Threatening Serious TEAE | 0 Participants |
Primary
Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring.
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.
Time frame: Baseline (day -1) and day 14
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | SupraVentricular Tachycardia (lasting > 10 beats (Day 14) | 3 Participants |
| Placebo | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Second Degree AV Block - Type I (Day-1) | 1 Participants |
| Placebo | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Frequent Supraventricular Premature Beats (APBs) (>100/24hrs) (Day-1) | 2 Participants |
| Placebo | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Second Degree AV Block - Type II(Day 14) | 1 Participants |
| Placebo | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Average Hourly Daytime Heart Rate < 50 bpm (daytime defined as 7 am-10 pm) (Day 14) | 0 Participants |
| Placebo | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Second Degree AV Block - Type I (Day 14) | 2 Participants |
| Placebo | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Sinus Bradycardia (HR < 40 bpm)(Day-1) | 0 Participants |
| Placebo | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Other arrhythmias (Day 14) | 18 Participants |
| Placebo | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Average Hourly Daytime Heart Rate < 50 bpm (daytime defined as 7 am-10 pm)(Day-1) | 0 Participants |
| Placebo | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Frequent Ventricular Ectopic Beats (VEs) (> 200/24hrs) (Day 14) | 1 Participants |
| Placebo | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Presence of NSVT (Non-Sustained Ventricular Tachycardia) episodes (Day 14) | 0 Participants |
| Placebo | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | SupraVentricular Tachycardia (lasting > 10 beats) (Day-1) | 4 Participants |
| Placebo | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Sinus Bradycardia (HR < 40 bpm) | 0 Participants |
| Placebo | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Frequent Ventricular Ectopic Beats (VEs) (> 200/24hrs) (Day-1) | 1 Participants |
| Placebo | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Frequent Supraventricular Premature Beats (APBs) (>100/24hrs) (Day 14) | 1 Participants |
| Placebo | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Other arrhythmias (Day-1) | 17 Participants |
| Placebo | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | At least three monomorphic beats in a row (Day 14) | 0 Participants |
| 50 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Second Degree AV Block - Type II(Day 14) | 0 Participants |
| 50 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Other arrhythmias (Day-1) | 13 Participants |
| 50 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Average Hourly Daytime Heart Rate < 50 bpm (daytime defined as 7 am-10 pm) (Day 14) | 0 Participants |
| 50 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | SupraVentricular Tachycardia (lasting > 10 beats (Day 14) | 3 Participants |
| 50 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Frequent Supraventricular Premature Beats (APBs) (>100/24hrs) (Day 14) | 0 Participants |
| 50 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Frequent Supraventricular Premature Beats (APBs) (>100/24hrs) (Day-1) | 1 Participants |
| 50 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Sinus Bradycardia (HR < 40 bpm) | 0 Participants |
| 50 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Frequent Ventricular Ectopic Beats (VEs) (> 200/24hrs) (Day-1) | 4 Participants |
| 50 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | At least three monomorphic beats in a row (Day 14) | 0 Participants |
| 50 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Second Degree AV Block - Type I (Day-1) | 0 Participants |
| 50 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Second Degree AV Block - Type I (Day 14) | 0 Participants |
| 50 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Sinus Bradycardia (HR < 40 bpm)(Day-1) | 0 Participants |
| 50 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Presence of NSVT (Non-Sustained Ventricular Tachycardia) episodes (Day 14) | 0 Participants |
| 50 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | SupraVentricular Tachycardia (lasting > 10 beats) (Day-1) | 5 Participants |
| 50 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Average Hourly Daytime Heart Rate < 50 bpm (daytime defined as 7 am-10 pm)(Day-1) | 0 Participants |
| 50 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Other arrhythmias (Day 14) | 14 Participants |
| 50 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Frequent Ventricular Ectopic Beats (VEs) (> 200/24hrs) (Day 14) | 4 Participants |
| 100 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Second Degree AV Block - Type I (Day-1) | 0 Participants |
| 100 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Average Hourly Daytime Heart Rate < 50 bpm (daytime defined as 7 am-10 pm)(Day-1) | 1 Participants |
| 100 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Frequent Supraventricular Premature Beats (APBs) (>100/24hrs) (Day-1) | 3 Participants |
| 100 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Frequent Ventricular Ectopic Beats (VEs) (> 200/24hrs) (Day-1) | 1 Participants |
| 100 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Sinus Bradycardia (HR < 40 bpm)(Day-1) | 1 Participants |
| 100 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | SupraVentricular Tachycardia (lasting > 10 beats) (Day-1) | 4 Participants |
| 100 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | At least three monomorphic beats in a row (Day 14) | 0 Participants |
| 100 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Average Hourly Daytime Heart Rate < 50 bpm (daytime defined as 7 am-10 pm) (Day 14) | 0 Participants |
| 100 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Frequent Supraventricular Premature Beats (APBs) (>100/24hrs) (Day 14) | 0 Participants |
| 100 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Frequent Ventricular Ectopic Beats (VEs) (> 200/24hrs) (Day 14) | 0 Participants |
| 100 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Other arrhythmias (Day 14) | 13 Participants |
| 100 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Presence of NSVT (Non-Sustained Ventricular Tachycardia) episodes (Day 14) | 0 Participants |
| 100 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Second Degree AV Block - Type I (Day 14) | 0 Participants |
| 100 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Second Degree AV Block - Type II(Day 14) | 0 Participants |
| 100 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Sinus Bradycardia (HR < 40 bpm) | 0 Participants |
| 100 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | SupraVentricular Tachycardia (lasting > 10 beats (Day 14) | 1 Participants |
| 100 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Other arrhythmias (Day-1) | 15 Participants |
| 150 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | SupraVentricular Tachycardia (lasting > 10 beats) (Day-1) | 2 Participants |
| 150 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Other arrhythmias (Day 14) | 15 Participants |
| 150 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Sinus Bradycardia (HR < 40 bpm)(Day-1) | 0 Participants |
| 150 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Presence of NSVT (Non-Sustained Ventricular Tachycardia) episodes (Day 14) | 1 Participants |
| 150 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Second Degree AV Block - Type I (Day-1) | 0 Participants |
| 150 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Second Degree AV Block - Type I (Day 14) | 0 Participants |
| 150 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Frequent Ventricular Ectopic Beats (VEs) (> 200/24hrs) (Day-1) | 0 Participants |
| 150 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Average Hourly Daytime Heart Rate < 50 bpm (daytime defined as 7 am-10 pm) (Day 14) | 0 Participants |
| 150 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Second Degree AV Block - Type II(Day 14) | 1 Participants |
| 150 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Frequent Supraventricular Premature Beats (APBs) (>100/24hrs) (Day-1) | 0 Participants |
| 150 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Sinus Bradycardia (HR < 40 bpm) | 1 Participants |
| 150 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Average Hourly Daytime Heart Rate < 50 bpm (daytime defined as 7 am-10 pm)(Day-1) | 0 Participants |
| 150 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Other arrhythmias (Day-1) | 15 Participants |
| 150 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Frequent Supraventricular Premature Beats (APBs) (>100/24hrs) (Day 14) | 0 Participants |
| 150 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | At least three monomorphic beats in a row (Day 14) | 1 Participants |
| 150 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Frequent Ventricular Ectopic Beats (VEs) (> 200/24hrs) (Day 14) | 0 Participants |
| 150 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | SupraVentricular Tachycardia (lasting > 10 beats (Day 14) | 1 Participants |
| 300 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Average Hourly Daytime Heart Rate < 50 bpm (daytime defined as 7 am-10 pm) (Day 14) | 1 Participants |
| 300 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | SupraVentricular Tachycardia (lasting > 10 beats (Day 14) | 1 Participants |
| 300 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Second Degree AV Block - Type II(Day 14) | 0 Participants |
| 300 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Other arrhythmias (Day 14) | 13 Participants |
| 300 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Sinus Bradycardia (HR < 40 bpm)(Day-1) | 0 Participants |
| 300 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Frequent Supraventricular Premature Beats (APBs) (>100/24hrs) (Day-1) | 0 Participants |
| 300 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Frequent Ventricular Ectopic Beats (VEs) (> 200/24hrs) (Day-1) | 2 Participants |
| 300 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | SupraVentricular Tachycardia (lasting > 10 beats) (Day-1) | 1 Participants |
| 300 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Presence of NSVT (Non-Sustained Ventricular Tachycardia) episodes (Day 14) | 0 Participants |
| 300 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Second Degree AV Block - Type I (Day-1) | 0 Participants |
| 300 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Other arrhythmias (Day-1) | 12 Participants |
| 300 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Sinus Bradycardia (HR < 40 bpm) | 0 Participants |
| 300 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Frequent Ventricular Ectopic Beats (VEs) (> 200/24hrs) (Day 14) | 1 Participants |
| 300 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Second Degree AV Block - Type I (Day 14) | 0 Participants |
| 300 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | At least three monomorphic beats in a row (Day 14) | 0 Participants |
| 300 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Average Hourly Daytime Heart Rate < 50 bpm (daytime defined as 7 am-10 pm)(Day-1) | 0 Participants |
| 300 mg BAY3427080 | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Frequent Supraventricular Premature Beats (APBs) (>100/24hrs) (Day 14) | 0 Participants |
Primary
Number of Participants With Clinically Significant Abnormalities Detected Upon Physical Examination.
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).
Time frame: At day 14
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Clinically Significant Abnormalities Detected Upon Physical Examination. | 1 Participants |
| 50 mg BAY3427080 | Number of Participants With Clinically Significant Abnormalities Detected Upon Physical Examination. | 0 Participants |
| 100 mg BAY3427080 | Number of Participants With Clinically Significant Abnormalities Detected Upon Physical Examination. | 2 Participants |
| 150 mg BAY3427080 | Number of Participants With Clinically Significant Abnormalities Detected Upon Physical Examination. | 1 Participants |
| 300 mg BAY3427080 | Number of Participants With Clinically Significant Abnormalities Detected Upon Physical Examination. | 2 Participants |
Primary
Number of Participants With Clinically Significant Abnormalities on the 12-lead ECGs
Reported results are cardiovascular system-examination findings at day 14. Clinically significance was decided by investigator. The findings are presented as abnormal (clinically significant).
Time frame: At day 14
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Clinically Significant Abnormalities on the 12-lead ECGs | 0 Participants |
| 50 mg BAY3427080 | Number of Participants With Clinically Significant Abnormalities on the 12-lead ECGs | 0 Participants |
| 100 mg BAY3427080 | Number of Participants With Clinically Significant Abnormalities on the 12-lead ECGs | 1 Participants |
| 150 mg BAY3427080 | Number of Participants With Clinically Significant Abnormalities on the 12-lead ECGs | 0 Participants |
| 300 mg BAY3427080 | Number of Participants With Clinically Significant Abnormalities on the 12-lead ECGs | 0 Participants |
Primary
Terminal Elimination Half-life (t½) of BAY3427080
Terminal elimination half-life of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration.
Time frame: On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours)
Population: Participants in PK population with available data are reported. Participants who received placebo were not included in the PK population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| 50 mg BAY3427080 | Terminal Elimination Half-life (t½) of BAY3427080 | Day 1 | 2.409 hr | Geometric Coefficient of Variation 34.15 |
| 50 mg BAY3427080 | Terminal Elimination Half-life (t½) of BAY3427080 | Day 14 | 2.698 hr | Geometric Coefficient of Variation 21.64 |
| 50 mg BAY3427080 | Terminal Elimination Half-life (t½) of BAY3427080 | Day 7 | 2.443 hr | Geometric Coefficient of Variation 9.33 |
| 100 mg BAY3427080 | Terminal Elimination Half-life (t½) of BAY3427080 | Day 1 | 1.903 hr | Geometric Coefficient of Variation 11.98 |
| 100 mg BAY3427080 | Terminal Elimination Half-life (t½) of BAY3427080 | Day 14 | 2.042 hr | — |
| 100 mg BAY3427080 | Terminal Elimination Half-life (t½) of BAY3427080 | Day 7 | 3.303 hr | Geometric Coefficient of Variation 21.2 |
| 150 mg BAY3427080 | Terminal Elimination Half-life (t½) of BAY3427080 | Day 7 | 3.482 hr | Geometric Coefficient of Variation 22.57 |
| 150 mg BAY3427080 | Terminal Elimination Half-life (t½) of BAY3427080 | Day 1 | 3.965 hr | Geometric Coefficient of Variation 45.94 |
| 150 mg BAY3427080 | Terminal Elimination Half-life (t½) of BAY3427080 | Day 14 | 21.593 hr | Geometric Coefficient of Variation 24.58 |
| 300 mg BAY3427080 | Terminal Elimination Half-life (t½) of BAY3427080 | Day 1 | 3.142 hr | Geometric Coefficient of Variation 18.92 |
| 300 mg BAY3427080 | Terminal Elimination Half-life (t½) of BAY3427080 | Day 14 | 20.427 hr | Geometric Coefficient of Variation 22.85 |
| 300 mg BAY3427080 | Terminal Elimination Half-life (t½) of BAY3427080 | Day 7 | 2.271 hr | — |
Primary
Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080
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.
Time frame: On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours)
Population: Participants who received placebo were not included in the PK population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| 50 mg BAY3427080 | Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080 | Day 1 | 1.360 hr | Geometric Coefficient of Variation 40.01 |
| 50 mg BAY3427080 | Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080 | Day 14 | 1.265 hr | Geometric Coefficient of Variation 46.32 |
| 50 mg BAY3427080 | Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080 | Day 7 | 1.432 hr | Geometric Coefficient of Variation 39.25 |
| 100 mg BAY3427080 | Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080 | Day 1 | 1.320 hr | Geometric Coefficient of Variation 38.79 |
| 100 mg BAY3427080 | Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080 | Day 14 | 1.445 hr | Geometric Coefficient of Variation 56.71 |
| 100 mg BAY3427080 | Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080 | Day 7 | 1.623 hr | Geometric Coefficient of Variation 43.19 |
| 150 mg BAY3427080 | Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080 | Day 7 | 1.536 hr | Geometric Coefficient of Variation 40.08 |
| 150 mg BAY3427080 | Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080 | Day 1 | 1.521 hr | Geometric Coefficient of Variation 41.95 |
| 150 mg BAY3427080 | Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080 | Day 14 | 1.296 hr | Geometric Coefficient of Variation 23.35 |
| 300 mg BAY3427080 | Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080 | Day 1 | 1.471 hr | Geometric Coefficient of Variation 63.05 |
| 300 mg BAY3427080 | Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080 | Day 14 | 1.342 hr | Geometric Coefficient of Variation 33.46 |
| 300 mg BAY3427080 | Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080 | Day 7 | 1.754 hr | Geometric Coefficient of Variation 56.18 |
Primary
Withdrawals Due to AEs up to Day 21
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.
Time frame: On or after first drug administration up to end of study (Day 21)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Withdrawals Due to AEs up to Day 21 | Any TEAE Leading to Discontinuation of Study Drug | 0 Participants |
| Placebo | Withdrawals Due to AEs up to Day 21 | Any TEAE Leading to Study Discontinuation | 0 Participants |
| 50 mg BAY3427080 | Withdrawals Due to AEs up to Day 21 | Any TEAE Leading to Discontinuation of Study Drug | 0 Participants |
| 50 mg BAY3427080 | Withdrawals Due to AEs up to Day 21 | Any TEAE Leading to Study Discontinuation | 0 Participants |
| 100 mg BAY3427080 | Withdrawals Due to AEs up to Day 21 | Any TEAE Leading to Discontinuation of Study Drug | 0 Participants |
| 100 mg BAY3427080 | Withdrawals Due to AEs up to Day 21 | Any TEAE Leading to Study Discontinuation | 0 Participants |
| 150 mg BAY3427080 | Withdrawals Due to AEs up to Day 21 | Any TEAE Leading to Study Discontinuation | 0 Participants |
| 150 mg BAY3427080 | Withdrawals Due to AEs up to Day 21 | Any TEAE Leading to Discontinuation of Study Drug | 0 Participants |
| 300 mg BAY3427080 | Withdrawals Due to AEs up to Day 21 | Any TEAE Leading to Discontinuation of Study Drug | 0 Participants |
| 300 mg BAY3427080 | Withdrawals Due to AEs up to Day 21 | Any TEAE Leading to Study Discontinuation | 0 Participants |
Secondary
Change From Baseline (Day-1) to Day 1 and Day 7 in Luteinizing Hormone (AUC0-8)
Change in Luteinizing Hormone(LH) AUC from time zero to 8 hours. Pre-dose samples for LH were taken within 30 minutes prior to dose administration.
Time frame: baseline (day-1) to day 1 and day 7, pre-dose and post-dose (0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 8.0, 12.0 and 24.0 hours)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline (Day-1) to Day 1 and Day 7 in Luteinizing Hormone (AUC0-8) | Day -1 | 295.4 h*U/L | Standard Deviation 82.64 |
| Placebo | Change From Baseline (Day-1) to Day 1 and Day 7 in Luteinizing Hormone (AUC0-8) | Change from Day -1 to Day 1 | 14.4 h*U/L | Standard Deviation 31.33 |
| Placebo | Change From Baseline (Day-1) to Day 1 and Day 7 in Luteinizing Hormone (AUC0-8) | Change from Day -1 to Day 7 | 12.4 h*U/L | Standard Deviation 57.46 |
| 50 mg BAY3427080 | Change From Baseline (Day-1) to Day 1 and Day 7 in Luteinizing Hormone (AUC0-8) | Change from Day -1 to Day 7 | 22.9 h*U/L | Standard Deviation 37.07 |
| 50 mg BAY3427080 | Change From Baseline (Day-1) to Day 1 and Day 7 in Luteinizing Hormone (AUC0-8) | Day -1 | 295.5 h*U/L | Standard Deviation 85.22 |
| 50 mg BAY3427080 | Change From Baseline (Day-1) to Day 1 and Day 7 in Luteinizing Hormone (AUC0-8) | Change from Day -1 to Day 1 | 4.7 h*U/L | Standard Deviation 35.8 |
| 100 mg BAY3427080 | Change From Baseline (Day-1) to Day 1 and Day 7 in Luteinizing Hormone (AUC0-8) | Change from Day -1 to Day 7 | 10.2 h*U/L | Standard Deviation 20.49 |
| 100 mg BAY3427080 | Change From Baseline (Day-1) to Day 1 and Day 7 in Luteinizing Hormone (AUC0-8) | Change from Day -1 to Day 1 | -10.0 h*U/L | Standard Deviation 21.9 |
| 100 mg BAY3427080 | Change From Baseline (Day-1) to Day 1 and Day 7 in Luteinizing Hormone (AUC0-8) | Day -1 | 290.8 h*U/L | Standard Deviation 85.83 |
| 150 mg BAY3427080 | Change From Baseline (Day-1) to Day 1 and Day 7 in Luteinizing Hormone (AUC0-8) | Change from Day -1 to Day 1 | -31.1 h*U/L | Standard Deviation 38.28 |
| 150 mg BAY3427080 | Change From Baseline (Day-1) to Day 1 and Day 7 in Luteinizing Hormone (AUC0-8) | Change from Day -1 to Day 7 | -12.1 h*U/L | Standard Deviation 47.3 |
| 150 mg BAY3427080 | Change From Baseline (Day-1) to Day 1 and Day 7 in Luteinizing Hormone (AUC0-8) | Day -1 | 309.5 h*U/L | Standard Deviation 104.38 |
| 300 mg BAY3427080 | Change From Baseline (Day-1) to Day 1 and Day 7 in Luteinizing Hormone (AUC0-8) | Change from Day -1 to Day 7 | -4.4 h*U/L | Standard Deviation 33.43 |
| 300 mg BAY3427080 | Change From Baseline (Day-1) to Day 1 and Day 7 in Luteinizing Hormone (AUC0-8) | Change from Day -1 to Day 1 | -24.6 h*U/L | Standard Deviation 32.36 |
| 300 mg BAY3427080 | Change From Baseline (Day-1) to Day 1 and Day 7 in Luteinizing Hormone (AUC0-8) | Day -1 | 261.1 h*U/L | Standard Deviation 65.53 |
p-value: 0.376890% CI: [-27.8, 8.5]Linear mixed-effects model
p-value: 0.024890% CI: [-43.1, -6.8]Linear mixed-effects model
p-value: 0.000190% CI: [-62.1, -25.8]Linear mixed-effects model
p-value: 0.000490% CI: [-61.9, -23.8]Linear mixed-effects model
p-value: 0.481990% CI: [-14.2, 35.1]Linear mixed-effects model
p-value: 0.869490% CI: [-27.1, 22.2]Linear mixed-effects model
p-value: 0.110590% CI: [-48.6, 0.7]Linear mixed-effects model
p-value: 0.23990% CI: [-44.2, 7.4]Linear mixed-effects model
Secondary
Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Hot Flushes Severity Score as Measured by Twice Daily Paper Diary.
The hot flushes severity score was a composite of the frequency and severity of hot flushes, and was calculated as follows: number of mild hot flushes recorded on Day Y + number of moderate hot flushes recorded on Day Y × 2 + number of severe hot flushes recorded on Day Y × 3. Higher scores mean more severe hot flushes.
Time frame: Baseline (week -1) and week 1 , 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Hot Flushes Severity Score as Measured by Twice Daily Paper Diary. | Week -1 | 28.06 Scores on a scale | Standard Deviation 11.631 |
| Placebo | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Hot Flushes Severity Score as Measured by Twice Daily Paper Diary. | Change from Week -1 to Week 2 | -10.67 Scores on a scale | Standard Deviation 10.542 |
| Placebo | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Hot Flushes Severity Score as Measured by Twice Daily Paper Diary. | Change from Week -1 to Week 1 | -6.99 Scores on a scale | Standard Deviation 9.673 |
| 50 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Hot Flushes Severity Score as Measured by Twice Daily Paper Diary. | Change from Week -1 to Week 1 | -5.56 Scores on a scale | Standard Deviation 10.907 |
| 50 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Hot Flushes Severity Score as Measured by Twice Daily Paper Diary. | Week -1 | 33.74 Scores on a scale | Standard Deviation 8.875 |
| 50 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Hot Flushes Severity Score as Measured by Twice Daily Paper Diary. | Change from Week -1 to Week 2 | -8.02 Scores on a scale | Standard Deviation 13.031 |
| 100 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Hot Flushes Severity Score as Measured by Twice Daily Paper Diary. | Change from Week -1 to Week 1 | -14.48 Scores on a scale | Standard Deviation 14.275 |
| 100 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Hot Flushes Severity Score as Measured by Twice Daily Paper Diary. | Week -1 | 32.52 Scores on a scale | Standard Deviation 11.203 |
| 100 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Hot Flushes Severity Score as Measured by Twice Daily Paper Diary. | Change from Week -1 to Week 2 | -19.19 Scores on a scale | Standard Deviation 14.211 |
| 150 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Hot Flushes Severity Score as Measured by Twice Daily Paper Diary. | Week -1 | 27.87 Scores on a scale | Standard Deviation 7.72 |
| 150 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Hot Flushes Severity Score as Measured by Twice Daily Paper Diary. | Change from Week -1 to Week 2 | -22.82 Scores on a scale | Standard Deviation 9.505 |
| 150 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Hot Flushes Severity Score as Measured by Twice Daily Paper Diary. | Change from Week -1 to Week 1 | -17.03 Scores on a scale | Standard Deviation 9.996 |
| 300 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Hot Flushes Severity Score as Measured by Twice Daily Paper Diary. | Change from Week -1 to Week 1 | -12.23 Scores on a scale | Standard Deviation 7.284 |
| 300 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Hot Flushes Severity Score as Measured by Twice Daily Paper Diary. | Week -1 | 26.75 Scores on a scale | Standard Deviation 5.416 |
| 300 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Hot Flushes Severity Score as Measured by Twice Daily Paper Diary. | Change from Week -1 to Week 2 | -17.55 Scores on a scale | Standard Deviation 8.953 |
p-value: 0.0990% CI: [0.16, 10.42]Linear mixed-effects model
p-value: 0.148790% CI: [-9.55, 0.63]Linear mixed-effects model
p-value: 0.001290% CI: [-15.2, -5.15]Linear mixed-effects model
p-value: 0.054890% CI: [-11.37, -0.9]Linear mixed-effects model
p-value: 0.052290% CI: [1.03, 12.15]Linear mixed-effects model
p-value: 0.132690% CI: [-10.61, 0.48]Linear mixed-effects model
p-value: 0.000490% CI: [-17.73, -6.83]Linear mixed-effects model
p-value: 0.025390% CI: [-13.47, -2.11]Linear mixed-effects model
Secondary
Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Severity of Hot Flushes as Measured by Twice Daily Paper Diary
Participants documented the number of individual hot flushes experienced and rated the severity of each on a scale of 1 to 3 (mild = 1, moderate = 2, severe = 3). The diaries were completed based on recall twice daily, in the morning and evening.
Time frame: Baseline (week -1) and weeks 1, Week 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Severity of Hot Flushes as Measured by Twice Daily Paper Diary | Week -1 | 2.32 Scores on a scale | Standard Deviation 0.304 |
| Placebo | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Severity of Hot Flushes as Measured by Twice Daily Paper Diary | Change from Week -1 to Week 2 | -0.34 Scores on a scale | Standard Deviation 0.383 |
| Placebo | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Severity of Hot Flushes as Measured by Twice Daily Paper Diary | Change from Week -1 to Week 1 | -0.30 Scores on a scale | Standard Deviation 0.358 |
| 50 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Severity of Hot Flushes as Measured by Twice Daily Paper Diary | Change from Week -1 to Week 1 | -0.21 Scores on a scale | Standard Deviation 0.276 |
| 50 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Severity of Hot Flushes as Measured by Twice Daily Paper Diary | Week -1 | 2.31 Scores on a scale | Standard Deviation 0.319 |
| 50 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Severity of Hot Flushes as Measured by Twice Daily Paper Diary | Change from Week -1 to Week 2 | -0.23 Scores on a scale | Standard Deviation 0.242 |
| 100 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Severity of Hot Flushes as Measured by Twice Daily Paper Diary | Change from Week -1 to Week 1 | -0.23 Scores on a scale | Standard Deviation 0.318 |
| 100 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Severity of Hot Flushes as Measured by Twice Daily Paper Diary | Week -1 | 2.20 Scores on a scale | Standard Deviation 0.267 |
| 100 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Severity of Hot Flushes as Measured by Twice Daily Paper Diary | Change from Week -1 to Week 2 | -0.36 Scores on a scale | Standard Deviation 0.359 |
| 150 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Severity of Hot Flushes as Measured by Twice Daily Paper Diary | Week -1 | 2.16 Scores on a scale | Standard Deviation 0.379 |
| 150 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Severity of Hot Flushes as Measured by Twice Daily Paper Diary | Change from Week -1 to Week 2 | -0.88 Scores on a scale | Standard Deviation 0.656 |
| 150 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Severity of Hot Flushes as Measured by Twice Daily Paper Diary | Change from Week -1 to Week 1 | -0.51 Scores on a scale | Standard Deviation 0.542 |
| 300 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Severity of Hot Flushes as Measured by Twice Daily Paper Diary | Change from Week -1 to Week 1 | -0.34 Scores on a scale | Standard Deviation 0.533 |
| 300 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Severity of Hot Flushes as Measured by Twice Daily Paper Diary | Week -1 | 2.19 Scores on a scale | Standard Deviation 0.304 |
| 300 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Severity of Hot Flushes as Measured by Twice Daily Paper Diary | Change from Week -1 to Week 2 | -0.42 Scores on a scale | Standard Deviation 0.757 |
p-value: 0.464190% CI: [-0.12, 0.3]Linear mixed-effects model
p-value: 0.989490% CI: [-0.21, 0.21]LS means difference
p-value: 0.019990% CI: [-0.52, -0.09]Linear mixed-effects model
p-value: 0.390790% CI: [-0.34, 0.11]Linear mixed-effects model
p-value: 0.539390% CI: [-0.17, 0.38]Linear mixed-effects model
p-value: 0.793190% CI: [-0.33, 0.24]Linear mixed-effects model
p-value: 0.000490% CI: [-0.92, -0.35]Linear mixed-effects model
p-value: 0.373990% CI: [-0.45, 0.13]Linear mixed-effects model
Secondary
Change From Baseline (Week -1) at Weeks 1, 2 in Frequency of Moderate to Severe Hot Flushes as Measured by Twice Daily Paper Diary Throughout Study
Hot flush frequency and hot flush severity were obtained using the Hot Flush paper Diary. Subjects documented the number of individual hot flushes experienced and rated the severity of each on a scale of 1 to 3 (mild = 1, moderate = 2, severe = 3). The diaries were completed based on recall twice daily, in the morning and evening.
Time frame: Baseline (week -1) and Week 1 ,Week 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline (Week -1) at Weeks 1, 2 in Frequency of Moderate to Severe Hot Flushes as Measured by Twice Daily Paper Diary Throughout Study | Baseline (Week -1) | 10.44 Hot flushes | Standard Deviation 3.866 |
| Placebo | Change From Baseline (Week -1) at Weeks 1, 2 in Frequency of Moderate to Severe Hot Flushes as Measured by Twice Daily Paper Diary Throughout Study | Change from Week -1 to Week 2 | -3.87 Hot flushes | Standard Deviation 4.179 |
| Placebo | Change From Baseline (Week -1) at Weeks 1, 2 in Frequency of Moderate to Severe Hot Flushes as Measured by Twice Daily Paper Diary Throughout Study | Change from Week -1 to Week 1 | -2.53 Hot flushes | Standard Deviation 3.645 |
| 50 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Frequency of Moderate to Severe Hot Flushes as Measured by Twice Daily Paper Diary Throughout Study | Change from Week -1 to Week 1 | -1.91 Hot flushes | Standard Deviation 4.61 |
| 50 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Frequency of Moderate to Severe Hot Flushes as Measured by Twice Daily Paper Diary Throughout Study | Baseline (Week -1) | 12.70 Hot flushes | Standard Deviation 3.385 |
| 50 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Frequency of Moderate to Severe Hot Flushes as Measured by Twice Daily Paper Diary Throughout Study | Change from Week -1 to Week 2 | -3.07 Hot flushes | Standard Deviation 5.647 |
| 100 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Frequency of Moderate to Severe Hot Flushes as Measured by Twice Daily Paper Diary Throughout Study | Change from Week -1 to Week 1 | -5.35 Hot flushes | Standard Deviation 5.153 |
| 100 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Frequency of Moderate to Severe Hot Flushes as Measured by Twice Daily Paper Diary Throughout Study | Baseline (Week -1) | 12.04 Hot flushes | Standard Deviation 3.606 |
| 100 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Frequency of Moderate to Severe Hot Flushes as Measured by Twice Daily Paper Diary Throughout Study | Change from Week -1 to Week 2 | -7.09 Hot flushes | Standard Deviation 4.915 |
| 150 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Frequency of Moderate to Severe Hot Flushes as Measured by Twice Daily Paper Diary Throughout Study | Baseline (Week -1) | 10.22 Hot flushes | Standard Deviation 2.976 |
| 150 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Frequency of Moderate to Severe Hot Flushes as Measured by Twice Daily Paper Diary Throughout Study | Change from Week -1 to Week 2 | -8.62 Hot flushes | Standard Deviation 3.749 |
| 150 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Frequency of Moderate to Severe Hot Flushes as Measured by Twice Daily Paper Diary Throughout Study | Change from Week -1 to Week 1 | -6.36 Hot flushes | Standard Deviation 3.818 |
| 300 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Frequency of Moderate to Severe Hot Flushes as Measured by Twice Daily Paper Diary Throughout Study | Change from Week -1 to Week 1 | -4.49 Hot flushes | Standard Deviation 2.801 |
| 300 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Frequency of Moderate to Severe Hot Flushes as Measured by Twice Daily Paper Diary Throughout Study | Baseline (Week -1) | 9.90 Hot flushes | Standard Deviation 2.107 |
| 300 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Frequency of Moderate to Severe Hot Flushes as Measured by Twice Daily Paper Diary Throughout Study | Change from Week -1 to Week 2 | -6.54 Hot flushes | Standard Deviation 3.453 |
Secondary
Change From Baseline (Week -1) at Weeks 1, 2 in Night-time Awakenings (NTA) Secondary to Hot Flushes as Measured by Paper Diary
The number of NTAs secondary to hot flushes was the sum of the number of moderate and severe night-time hot flushes recorded the following morning (twice-daily hot flush diary) or recorded contemporaneously on the continuous diary.
Time frame: Baseline (week-1) and weeks 1 , 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline (Week -1) at Weeks 1, 2 in Night-time Awakenings (NTA) Secondary to Hot Flushes as Measured by Paper Diary | Change from Week -1 to Week 1 | -0.77 Night-time Awakenings | Standard Deviation 2.066 |
| Placebo | Change From Baseline (Week -1) at Weeks 1, 2 in Night-time Awakenings (NTA) Secondary to Hot Flushes as Measured by Paper Diary | Baseline (Week -1) | 4.51 Night-time Awakenings | Standard Deviation 2.282 |
| Placebo | Change From Baseline (Week -1) at Weeks 1, 2 in Night-time Awakenings (NTA) Secondary to Hot Flushes as Measured by Paper Diary | Change from Week -1 to Week 2 | -1.44 Night-time Awakenings | Standard Deviation 2.128 |
| 50 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Night-time Awakenings (NTA) Secondary to Hot Flushes as Measured by Paper Diary | Change from Week -1 to Week 2 | -1.12 Night-time Awakenings | Standard Deviation 2.665 |
| 50 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Night-time Awakenings (NTA) Secondary to Hot Flushes as Measured by Paper Diary | Baseline (Week -1) | 5.61 Night-time Awakenings | Standard Deviation 1.785 |
| 50 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Night-time Awakenings (NTA) Secondary to Hot Flushes as Measured by Paper Diary | Change from Week -1 to Week 1 | -0.80 Night-time Awakenings | Standard Deviation 2.448 |
| 100 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Night-time Awakenings (NTA) Secondary to Hot Flushes as Measured by Paper Diary | Baseline (Week -1) | 5.41 Night-time Awakenings | Standard Deviation 2.337 |
| 100 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Night-time Awakenings (NTA) Secondary to Hot Flushes as Measured by Paper Diary | Change from Week -1 to Week 2 | -3.00 Night-time Awakenings | Standard Deviation 2.751 |
| 100 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Night-time Awakenings (NTA) Secondary to Hot Flushes as Measured by Paper Diary | Change from Week -1 to Week 1 | -2.52 Night-time Awakenings | Standard Deviation 2.604 |
| 150 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Night-time Awakenings (NTA) Secondary to Hot Flushes as Measured by Paper Diary | Change from Week -1 to Week 1 | -2.75 Night-time Awakenings | Standard Deviation 2.335 |
| 150 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Night-time Awakenings (NTA) Secondary to Hot Flushes as Measured by Paper Diary | Change from Week -1 to Week 2 | -3.83 Night-time Awakenings | Standard Deviation 2.008 |
| 150 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Night-time Awakenings (NTA) Secondary to Hot Flushes as Measured by Paper Diary | Baseline (Week -1) | 4.74 Night-time Awakenings | Standard Deviation 2.111 |
| 300 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Night-time Awakenings (NTA) Secondary to Hot Flushes as Measured by Paper Diary | Change from Week -1 to Week 2 | -3.02 Night-time Awakenings | Standard Deviation 2.117 |
| 300 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Night-time Awakenings (NTA) Secondary to Hot Flushes as Measured by Paper Diary | Baseline (Week -1) | 4.76 Night-time Awakenings | Standard Deviation 1.443 |
| 300 mg BAY3427080 | Change From Baseline (Week -1) at Weeks 1, 2 in Night-time Awakenings (NTA) Secondary to Hot Flushes as Measured by Paper Diary | Change from Week -1 to Week 1 | -2.07 Night-time Awakenings | Standard Deviation 1.833 |
p-value: 0.002290% CI: [-2.74, -0.86]Linear mixed-effects model
p-value: 0.148290% CI: [-0.12, 1.8]Linear mixed-effects model
p-value: 0.073490% CI: [-1.99, -0.09]Linear mixed-effects model
p-value: 0.06690% CI: [-2.08, -0.12]Linear mixed-effects model
p-value: 0.059390% CI: [0.15, 2.2]Linear mixed-effects model
p-value: 0.135490% CI: [-1.95, 0.1]Linear mixed-effects model
p-value: 0.000590% CI: [-3.21, -1.2]Linear mixed-effects model
p-value: 0.030990% CI: [-2.43, -0.34]Linear mixed-effects model
Secondary
Change in Frequency From Baseline (Day -1), at Days 7, 14 of Hot Flushes as Measured by Continuous Day Time Diary.
Subjects recorded each hot flush and its severity on a scale of 1 to 3 (mild = 1, moderate = 2, severe = 3) in the hot flush paper diary as they occurred during the day and night.
Time frame: Baseline(day -1) and Day 7, 14
Population: Participants with available data reported.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change in Frequency From Baseline (Day -1), at Days 7, 14 of Hot Flushes as Measured by Continuous Day Time Diary. | Day 7 Change from Day -1 | -2.8 Hot flushes |
| Placebo | Change in Frequency From Baseline (Day -1), at Days 7, 14 of Hot Flushes as Measured by Continuous Day Time Diary. | Day 14 Change from Day -1 | -3.6 Hot flushes |
| 50 mg BAY3427080 | Change in Frequency From Baseline (Day -1), at Days 7, 14 of Hot Flushes as Measured by Continuous Day Time Diary. | Day 7 Change from Day -1 | -1.4 Hot flushes |
| 50 mg BAY3427080 | Change in Frequency From Baseline (Day -1), at Days 7, 14 of Hot Flushes as Measured by Continuous Day Time Diary. | Day 14 Change from Day -1 | -2.3 Hot flushes |
| 100 mg BAY3427080 | Change in Frequency From Baseline (Day -1), at Days 7, 14 of Hot Flushes as Measured by Continuous Day Time Diary. | Day 7 Change from Day -1 | -5.1 Hot flushes |
| 100 mg BAY3427080 | Change in Frequency From Baseline (Day -1), at Days 7, 14 of Hot Flushes as Measured by Continuous Day Time Diary. | Day 14 Change from Day -1 | -6.0 Hot flushes |
| 150 mg BAY3427080 | Change in Frequency From Baseline (Day -1), at Days 7, 14 of Hot Flushes as Measured by Continuous Day Time Diary. | Day 14 Change from Day -1 | -8.6 Hot flushes |
| 150 mg BAY3427080 | Change in Frequency From Baseline (Day -1), at Days 7, 14 of Hot Flushes as Measured by Continuous Day Time Diary. | Day 7 Change from Day -1 | -8.3 Hot flushes |
| 300 mg BAY3427080 | Change in Frequency From Baseline (Day -1), at Days 7, 14 of Hot Flushes as Measured by Continuous Day Time Diary. | Day 7 Change from Day -1 | -5.8 Hot flushes |
| 300 mg BAY3427080 | Change in Frequency From Baseline (Day -1), at Days 7, 14 of Hot Flushes as Measured by Continuous Day Time Diary. | Day 14 Change from Day -1 | -7.0 Hot flushes |
p-value: 0.379690% CI: [-1.2, 4]Linear mixed-effects model
p-value: 0.141390% CI: [-4.9, 0.3]Linear mixed-effects model
p-value: 0.000790% CI: [-8.1, -2.9]Linear mixed-effects model
p-value: 0.062490% CI: [-5.8, -0.4]Linear mixed-effects model
p-value: 0.29390% CI: [-0.7, 3.3]Linear mixed-effects model
p-value: 0.051290% CI: [-4.4, -0.4]Linear mixed-effects model
p-value: <0.000190% CI: [-7, -3]Linear mixed-effects model
p-value: 0.00890% CI: [-5.5, -1.3]Linear mixed-effects model
Secondary
Change in Frequency of Hot Flushes From Baseline (Day -1) at Days 7, 14 as Assessed by Skin Conductance
Sternal skin conductance monitors (the Bahr MonitorTM) and the associated algorithm software were supplied by Simplex Scientific LLC (Middleton, USA). Participants were instructed to push a button on the skin conductance monitor when they sensed a hot flush when fitted with the monitor and then provide details of the hot flush in the continuous hot flush diary. Sternal skin conductance monitors were fitted on Day -1 (24 hours±1 hour prior to the planned study drug administration on Day 1) and remained in place until after the Day 7 24-hour assessments were completed (on Day 8). Refitted around 30 minutes prior to study drug administration on Day 14 and remained in place until after the 24-hour assessments were completed on Day 15.
Time frame: Baseline (day -1) and days 7, 14
Population: Participants with available data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Frequency of Hot Flushes From Baseline (Day -1) at Days 7, 14 as Assessed by Skin Conductance | Baseline ( Day -1) | 5.486 Hot flushes | Standard Deviation 7.148 |
| Placebo | Change in Frequency of Hot Flushes From Baseline (Day -1) at Days 7, 14 as Assessed by Skin Conductance | Change from Day -1 to day 14 | -0.139 Hot flushes | Standard Deviation 8.0619 |
| Placebo | Change in Frequency of Hot Flushes From Baseline (Day -1) at Days 7, 14 as Assessed by Skin Conductance | Change from Day -1 to Day 7 | -0.857 Hot flushes | Standard Deviation 6.794 |
| 50 mg BAY3427080 | Change in Frequency of Hot Flushes From Baseline (Day -1) at Days 7, 14 as Assessed by Skin Conductance | Change from Day -1 to Day 7 | -3.986 Hot flushes | Standard Deviation 6.487 |
| 50 mg BAY3427080 | Change in Frequency of Hot Flushes From Baseline (Day -1) at Days 7, 14 as Assessed by Skin Conductance | Baseline ( Day -1) | 8.680 Hot flushes | Standard Deviation 4.72 |
| 50 mg BAY3427080 | Change in Frequency of Hot Flushes From Baseline (Day -1) at Days 7, 14 as Assessed by Skin Conductance | Change from Day -1 to day 14 | -2.642 Hot flushes | Standard Deviation 6.0682 |
| 100 mg BAY3427080 | Change in Frequency of Hot Flushes From Baseline (Day -1) at Days 7, 14 as Assessed by Skin Conductance | Change from Day -1 to Day 7 | -3.679 Hot flushes | Standard Deviation 4.67 |
| 100 mg BAY3427080 | Change in Frequency of Hot Flushes From Baseline (Day -1) at Days 7, 14 as Assessed by Skin Conductance | Baseline ( Day -1) | 7.787 Hot flushes | Standard Deviation 6.153 |
| 100 mg BAY3427080 | Change in Frequency of Hot Flushes From Baseline (Day -1) at Days 7, 14 as Assessed by Skin Conductance | Change from Day -1 to day 14 | -2.913 Hot flushes | Standard Deviation 6.4202 |
| 150 mg BAY3427080 | Change in Frequency of Hot Flushes From Baseline (Day -1) at Days 7, 14 as Assessed by Skin Conductance | Baseline ( Day -1) | 3.200 Hot flushes | Standard Deviation 4.945 |
| 150 mg BAY3427080 | Change in Frequency of Hot Flushes From Baseline (Day -1) at Days 7, 14 as Assessed by Skin Conductance | Change from Day -1 to day 14 | 0.600 Hot flushes | Standard Deviation 4.9261 |
| 150 mg BAY3427080 | Change in Frequency of Hot Flushes From Baseline (Day -1) at Days 7, 14 as Assessed by Skin Conductance | Change from Day -1 to Day 7 | -2.197 Hot flushes | Standard Deviation 4.609 |
| 300 mg BAY3427080 | Change in Frequency of Hot Flushes From Baseline (Day -1) at Days 7, 14 as Assessed by Skin Conductance | Change from Day -1 to Day 7 | 0.000 Hot flushes | Standard Deviation 6.245 |
| 300 mg BAY3427080 | Change in Frequency of Hot Flushes From Baseline (Day -1) at Days 7, 14 as Assessed by Skin Conductance | Baseline ( Day -1) | 5.583 Hot flushes | Standard Deviation 7.242 |
| 300 mg BAY3427080 | Change in Frequency of Hot Flushes From Baseline (Day -1) at Days 7, 14 as Assessed by Skin Conductance | Change from Day -1 to day 14 | -2.908 Hot flushes | Standard Deviation 7.1204 |