A phase I, open-label, single-dose study to evaluate the effect of hepatic impairment on the pharmacokinetics and safety of futibatinib.

Author: GaoLing, HangaiNanae, MakrisLukas, MarburyThomas, PintiMark, RondonJuan Carlos, TomlinsonGareth, WacheckVolker, YamamiyaIkuo

Paper Details 
Original Abstract of the Article :
Futibatinib is a covalently binding FGFR1-4 inhibitor that received US Food and Drug Administration approval for the treatment of patients with previously treated, advanced intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions/rearrangements. This phase I trial evaluated the pharmacokinetics ...See full text at original site
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引用元:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10499415/

データ提供:米国国立医学図書館(NLM)

Evaluating Futibatinib Pharmacokinetics in Hepatic Impairment

The development of new therapies for [advanced intrahepatic cholangiocarcinoma] is a critical area of research, aiming to improve treatment outcomes and address the challenges of drug metabolism in patients with hepatic impairment. This study investigated the pharmacokinetics (PKs), safety, and tolerability of futibatinib, a novel FGFR1-4 inhibitor, in subjects with different levels of hepatic impairment. The study found that futibatinib exhibited a slight increase in exposure in subjects with hepatic impairment, but these changes were not considered clinically significant. Furthermore, futibatinib was well-tolerated, with only minor adverse events observed. These findings provide valuable insights into the safety and PK profile of futibatinib in patients with hepatic impairment, suggesting that dose adjustments may not be necessary.

Futibatinib: A Promising Therapy for Hepatically Impaired Patients

This research provides reassuring evidence about the safety and PK profile of futibatinib in patients with hepatic impairment. The study found that futibatinib exhibited a slight increase in exposure in subjects with hepatic impairment, but these changes were not considered clinically significant. Furthermore, futibatinib was well-tolerated, with only minor adverse events observed. These findings suggest that dose adjustments may not be necessary for futibatinib in patients with hepatic impairment, potentially expanding its therapeutic potential for a wider range of patients.

Navigating the Desert of Liver Disease

Liver disease can feel like a vast and challenging desert, with potential complications and limitations on treatment options. This research offers a beacon of hope by highlighting the safety and tolerability of futibatinib in patients with hepatic impairment. This finding potentially expands the therapeutic potential of futibatinib for a wider range of patients, offering a more hopeful journey through the desert of liver disease.

Dr.Camel's Conclusion

This research, like a camel navigating a challenging desert landscape, provides reassuring insights into the safety and PK profile of futibatinib in patients with hepatic impairment. The findings suggest that dose adjustments may not be necessary for futibatinib in these patients, potentially expanding its therapeutic potential and offering a more hopeful journey through the desert of liver disease.

Date :
  1. Date Completed 2023-09-15
  2. Date Revised 2023-09-19
Further Info :

Pubmed ID

37553804

DOI: Digital Object Identifier

PMC10499415

Related Literature

SNS
PICO Info
in preparation
Languages

English

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