Table 1.
Subject Demographics and Clinical Characteristics From the First-in-Man and PK/PD Pivotal Studies
| First-in-Man (n = 10) | PK/PD Pivotal (n = 17∗) | |
|---|---|---|
| Age, yrs | 69.9 ± 8.6 | 68.0 ± 9.5 |
| Male, % | 80.0 | 88.2 |
| Weight, kg | 83.3 ± 17.2 | 96.6 ± 15.6 |
| BMI, kg/m2 | 27.5 ± 4.5 | 31.0 ± 4.6 |
| Systolic BP, mm Hg | 115.6 ± 15.3 | 134.0 ± 16.1 |
| Diastolic BP, mm Hg | 68.2 ± 7.7 | 78.4 ± 6.5 |
| Heart rate, beats/min | 75.4 ± 19.5 | 67.8 ± 10.9 |
| NYHA functional class, % | ||
| II | 100 | 76.5 |
| III | 0.0 | 23.5 |
| Sodium, mmol/l | 140.0 (138.2–141.5) | 142.2 (135–147) |
| Potassium, mmol/l | 4.5 (4.3–4.7) | 4.7 (4.0–5.6) |
| Creatinine, μmol/l | 120.0 (102.5–131.2) | 105.5 (80.5–143.24) |
| eGFR, ml/min/1.73 m2 | 53.8 (49.5–58.7) | 63.4 (41–97) |
| proBNP, pg/ml | 1,130 (732–2,115) | 897 (41–2,514) |
| Arrhythmia, % | 50.0 | 82.4 |
| AMI, % | 50.0 | 70.6 |
| Diabetes, % | 10.0 | 35.3 |
| Maintenance diuretic use, furosemide equivalent dose mg/day | 44.0 ± 12.6 | 40 ± 0 |
Values are mean ± SD, %, or median (interquartile range).
AMI = acute myocardial infarction; BMI = body mass index; BNP = brain natriuretic peptide; eGFR = estimated glomerular filtration rate; IV = intravenous; N/A = not available; NYHA = New York Heart Association; PK/PD = Pharmacokinetic and pharmacokinetic; proBNP = pro–B-type natriuretic protein; SC = subcutaneous.
∗
17 patients were enrolled, 1 patient withdrew before dosing. One subject was found to have high pre-dose concentrations of furosemide and was not included in the PK, PD, or statistical analysis.