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.
Age range
45 Years – 65 Years
Sex
FEMALE
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Maximum Observed Plasma Concentration (Cmax) of BAY3427080
Timeframe: 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 to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080
Timeframe: 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 From Time Zero Extrapolated to Infinity (AUC0-∞) of BAY3427080
Timeframe: 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)
Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-τ) of BAY3427080
Timeframe: 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 (t½) of BAY3427080
Timeframe: 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 (CL/F) of BAY3427080
Timeframe: 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)
Number of Participants With Clinically Significant Abnormalities Detected Upon Physical Examination.
Timeframe: At day 14
Number of Participants With Clinically Significant Abnormalities on the 12-lead ECGs
Timeframe: At day 14
Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring.
Timeframe: Baseline (day -1) and day 14
Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Standing)
Timeframe: Baseline and day 14
Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Sitting)
Timeframe: Baseline and day 14
Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Standing)
Timeframe: Baseline and day 14
Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Sitting)
Timeframe: Baseline and day 14
Change From Baseline at Day 14 in Vital Signs: Pulse Rate
Timeframe: Baseline and day 14
Change From Baseline at Day 14 in Vital Signs: Respiratory Rate
Timeframe: Baseline and day 14
Change From Baseline at Day 14 in Vital Signs: Oxygen Saturation
Timeframe: Baseline and day 14
Change From Baseline at Day 14 in Vital Signs: Oral Body Temperature
Timeframe: Baseline and day 14
Change From Baseline at Day 14 in Vital Signs: Weight
Timeframe: Baseline and day 14
Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol.
Timeframe: Baseline and day 15
Change From Baseline at Day 15 for Laboratory Hormones Results: Follicle Stimulating Hormone
Timeframe: Baseline and day 15
Change From Baseline at Day 15 for Laboratory Hormones Results : Triiodothyronine Uptake
Timeframe: Baseline and day 15
Change From Baseline at Day 15 for Laboratory Hormones Results: Thyrotropin
Timeframe: Baseline and day 15
Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine
Timeframe: Baseline and day 15
Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol.
Timeframe: Baseline and day 14
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes.
Timeframe: Baseline and day 14
Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets.
Timeframe: Baseline and day 14
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration
Timeframe: Baseline and day 14
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes
Timeframe: Baseline and day 14
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume.
Timeframe: Baseline and day 14
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Hemoglobin
Timeframe: Baseline and day 14
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Distribution Width.
Timeframe: Baseline and day 14
Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hematocrit.
Timeframe: Baseline and day 14
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin.
Timeframe: Baseline and day 14
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase
Timeframe: Baseline and day 14
Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine.
Timeframe: Baseline and day 14
Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen.
Timeframe: Baseline and day 14
Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate African at Baseline
Timeframe: At Baseline
Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate Caucasian at Baseline
Timeframe: At Baseline
Change From Baseline at Day 14 for COAGULATION: Prothrombin International Normalized Ratio (INR)
Timeframe: Baseline and day 14
Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time
Timeframe: Baseline and day 14
Heart Rate (HR) - Change From Baseline (Day -1) at Day 14
Timeframe: Baseline (day -1) and day 14
Mean PR Interval - Change From Baseline (Day -1) at Day 14
Timeframe: Baseline (day -1) and day 14
Mean QRS Duration - Change From Baseline (Day -1) at Day 14
Timeframe: Baseline (day -1) and day 14
Mean QT Interval - Change From Baseline (Day -1) at Day 14
Timeframe: Baseline (day -1) and day 14
Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14
Timeframe: Baseline (day -1) and day 14
Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14
Timeframe: Baseline (day -1) and day 14
Nature and Severity of Adverse Events (AEs) up to Day 21
Timeframe: On or after first drug administration up to end of study (Day 21).
Withdrawals Due to AEs up to Day 21
Timeframe: On or after first drug administration up to end of study (Day 21)