The effect of mild and moderate hepatic impairment on the pharmacokinetics, safety and tolerability of balcinrenone.
Anna L Eriksson, Deeyen Karsanji, Bonifride Tuyishimire et al.
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In 30 seconds
This Phase I clinical trial evaluated the pharmacokinetics, safety, and tolerability of balcinrenone in individuals with mild and moderate hepatic impairment compared to those with normal hepatic function. The study found that in participants with moderate hepatic impairment, the area under the plasma concentration-time curve (AUC) increased by 30% compared to controls, while maximum plasma concentration (C max) remained similar. Balcinrenone was well tolerated overall.
Key findings
- In mild hepatic impairment, balcinrenone exposure was similar to normal hepatic function.
- Participants with moderate hepatic impairment showed a 30% increase in AUC compared to normal function.
- C max remained similar in both mild and moderate hepatic impairment groups.
- All adverse events reported were of mild to moderate intensity.
Why it matters
Understanding the pharmacokinetics of medications in patients with hepatic impairment is crucial for ensuring safety and efficacy. This study suggests that balcinrenone can be administered without dose adjustments in patients with mild or moderate hepatic impairment.