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, yrs69.9 ± 8.668 ± 9.5
Male, %8088.2
Weight, kg83.3 ± 17.296.6 ± 15.6
BMI, kg/m227.5 ± 4.531 ± 4.6
Systolic BP, mm Hg115.6 ± 15.3134.0 ± 16.1
Diastolic BP, mm Hg68.2 ± 7.778.4 ± 6.5
Heart rate, beats/min75.4 ± 19.567.8 ± 10.9
NYHA functional class, %
 II10076.5
 III0.023.5
Sodium, mmol/l140.0 (138.2–141.5)142.2 (135–147)
Potassium, mmol/l4.5 (4.3–4.7)4.7 (4.0–5.6)
Creatinine, μmol/l120.0 (102.5–131.2)105.5 (80.5–143.24)
eGFR, ml/min/1.73 m253.8 (49.5–58.7)63.4 (41–97)
proBNP, pg/ml1,130 (732–2,115)897 (41–2,514)
Arrhythmia, %50.082.4
AMI, %50.070.6
Diabetes, %10.035.3
Maintenance diuretic use, furosemide equivalent dose mg/day44 ± 12.640 ± 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.