Concentration-QT modeling demonstrates that the selective mineralocorticoid receptor modulator, balcinrenone (AZD9977), does not prolong QT interval.

ABSTRACT: Balcinrenone (AZD9977) is a selective mineralocorticoid receptor modulator in development in combination with dapagliflozin for treatment of heart failure with impaired kidney function and chronic kidney disease. A prespecified concentration-QT analysis was performed based on data from a phase I single ascending dose study prospectively designed as a thorough QT study substitute. Oral single doses of balcinrenone of 5-800 mg, plus fractionated doses of 800 and 1200 mg, were evaluated in 62 healthy male participants. Time-matched 12-lead digital electrocardiogram and plasma concentrations were measured pre-dose and up to 48 h postdose in the participants. Analysis was performed using a linear mixed-effect model, where baseline-adjusted Fridericia-corrected QT interval (ΔQTcF) was a dependen

SUBMITTER: Sundell J 

PROVIDER: S-EPMC11812937 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature