Effect of Food on Balcinrenone/Dapagliflozin Pharmacokinetics and the Pharmacokinetics of Balcinrenone When Dosed with a P-gp Inhibitor.
Anna L Eriksson, Deeyen Karsanji, Amy H Shi et al.
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In 30 seconds
This Phase 1 randomized controlled trial evaluated the pharmacokinetics of balcinrenone/dapagliflozin in 14 healthy participants under different conditions: fasted, fed, and with a P-gp inhibitor. The study found that balcinrenone exposure was similar in fed and fasted states, while dapagliflozin's maximum plasma concentration decreased in the fed state. Co-administration with quinidine increased balcinrenone exposure significantly.
Key findings
- Balcinrenone exposure was comparable in fed and fasted states (C max GMR 1.05, AUC inf GMR 1.12).
- Dapagliflozin AUC inf was similar in fed and fasted states (GMR 1.05), but C max decreased (GMR 0.59).
- Co-administration with quinidine increased balcinrenone C max by 1.48 and AUC inf by 1.24.
Why it matters
Understanding the pharmacokinetics of balcinrenone/dapagliflozin in relation to food intake and P-gp inhibitors is crucial for optimizing dosing strategies in patients with heart failure and chronic kidney disease, ensuring effective treatment without unnecessary dietary restrictions.