Cargando…

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

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...

Descripción completa

Detalles Bibliográficos
Autores principales:	Gao, Ling, Yamamiya, Ikuo, Pinti, Mark, Rondon, Juan Carlos, Marbury, Thomas, Tomlinson, Gareth, Makris, Lukas, Hangai, Nanae, Wacheck, Volker
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2023
Materias:	Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10499415/ https://www.ncbi.nlm.nih.gov/pubmed/37553804 http://dx.doi.org/10.1111/cts.13585

Ejemplares similares

Preclinical Evaluation of the FGFR-Family Inhibitor Futibatinib for Pediatric Rhabdomyosarcoma
por: Wu, Jerry T., et al.
Publicado: (2023)

A Single-Dose, Open-Label Study of the Pharmacokinetics, Safety, and Tolerability of Lisdexamfetamine Dimesylate in Individuals With Normal and Impaired Renal Function
por: Ermer, James, et al.
Publicado: (2016)

Pharmacokinetics of capmatinib in participants with hepatic impairment: A phase 1, open‐label, single‐dose, parallel‐group study
por: Chen, Xinhui, et al.
Publicado: (2021)

Futibatinib: second EMA approval for FGFR inhibitor in cholangiocarcinoma
por: Lamarca, A., et al.
Publicado: (2023)

Pharmacokinetics and Safety of Multiple-Dose Alpelisib in Participants with Moderate or Severe Hepatic Impairment: A Phase 1, Open-Label, Parallel Group Study
por: Marbury, Thomas, et al.
Publicado: (2023)

Phase I, first-in-human study of futibatinib, a highly selective, irreversible FGFR1–4 inhibitor in patients with advanced solid tumors
por: Bahleda, R., et al.
Publicado: (2020)

Futibatinib, an Irreversible FGFR1-4 Inhibitor for the Treatment of FGFR-Aberrant Tumors
por: Javle, Milind, et al.
Publicado: (2023)

Influence of Renal Impairment on the Pharmacokinetics of Afatinib: An Open-Label, Single-Dose Study
por: Wiebe, Sabrina, et al.
Publicado: (2016)

The Influence of Hepatic and Renal Impairment on the Pharmacokinetics of a Treatment for Herpes Zoster, Amenamevir (ASP2151): Phase 1, Open-Label, Single-Dose, Parallel-Group Studies
por: Kusawake, Tomohiro, et al.
Publicado: (2017)

Efficacy of futibatinib, an irreversible fibroblast growth factor receptor inhibitor, in FGFR-altered breast cancer
por: Saridogan, Turcin, et al.
Publicado: (2023)

Effect of hepatic impairment on the pharmacokinetics of vilaprisan: An open‐label, single‐dose, parallel‐group study
por: Chattopadhyay, Niladri, et al.
Publicado: (2019)

Effect of Hepatic Impairment on Eluxadoline Pharmacokinetics
por: Marbury, Thomas C., et al.
Publicado: (2017)

Effect of renal impairment on the pharmacokinetics of prucalopride: a single- dose open-label Phase I study
por: Smith, William B, et al.
Publicado: (2012)

An Open-Label Study of the Impact of Hepatic Impairment on the Pharmacokinetics and Safety of Single Oral and Intravenous Doses of Omadacycline
por: Kovacs, Steven J., et al.
Publicado: (2020)

Pharmacokinetics of conivaptan use in patients with severe hepatic impairment
por: Marbury, Thomas, et al.
Publicado: (2017)

Single‐Dose Pharmacokinetics and Safety of Solriamfetol in Participants With Normal or Impaired Renal Function and With End‐Stage Renal Disease Requiring Hemodialysis
por: Zomorodi, Katie, et al.
Publicado: (2019)

Pharmacokinetics of Gepotidacin in Renal Impairment
por: Hossain, Mohammad, et al.
Publicado: (2020)

Futibatinib, an Irreversible FGFR1–4 Inhibitor, in Patients with Advanced Solid Tumors Harboring FGF/FGFR Aberrations: A Phase I Dose-Expansion Study
por: Meric-Bernstam, Funda, et al.
Publicado: (2022)

Pharmacokinetic profile of defibrotide in patients with renal impairment
por: Tocchetti, Paola, et al.
Publicado: (2016)

Evaluation of the Pharmacokinetics and Safety of a Single Dose of Acalabrutinib in Subjects With Hepatic Impairment
por: Xu, Yan, et al.
Publicado: (2022)

The pharmacokinetics of dalbavancin in subjects with mild, moderate, or severe hepatic impairment
por: Dowell, J, et al.
Publicado: (2008)

A phase‐1, open‐label, single‐dose study of the pharmacokinetics of buparlisib in subjects with mild to severe hepatic impairment
por: Csonka, Denes, et al.
Publicado: (2016)

Single‐Dose Pharmacokinetics and Safety of Atogepant in Adults With Hepatic Impairment: Results From an Open‐Label, Phase 1 Trial
por: Boinpally, Ramesh, et al.
Publicado: (2021)

Single‐Dose Pharmacokinetics and Safety of Ubrogepant in Adults With Hepatic Impairment: Results From an Open‐Label, Phase 1 Trial
por: Boinpally, Ramesh, et al.
Publicado: (2022)

Characterization of the Effect of Renal Impairment on Upadacitinib Pharmacokinetics
por: Mohamed, Mohamed‐Eslam F., et al.
Publicado: (2019)

Characterization of the Effect of Hepatic Impairment on Upadacitinib Pharmacokinetics
por: Trueman, Sheryl, et al.
Publicado: (2019)

Pharmacokinetics of Voxelotor in Patients With Renal and Hepatic Impairment
por: Preston, Richard A., et al.
Publicado: (2020)

Effect of severe renal impairment on the pharmacokinetics of brigatinib
por: Gupta, Neeraj, et al.
Publicado: (2021)

Brigatinib pharmacokinetics in patients with chronic hepatic impairment
por: Hanley, Michael J., et al.
Publicado: (2023)

Pharmacokinetics and Tolerability of a Single Dose of Semaglutide, a Human Glucagon-Like Peptide-1 Analog, in Subjects With and Without Renal Impairment
por: Marbury, Thomas C., et al.
Publicado: (2017)

722. Pharmacokinetics (PK) and Safety of Lefamulin (LEF) After Single Intravenous Dose Administration in Subjects With Impaired Hepatic Function
por: Wicha, Wolfgang, et al.
Publicado: (2019)

982. Effect of Hepatic Impairment on the Safety and Pharmacokinetics of Rezafungin
por: Huguet, Jade, et al.
Publicado: (2021)

Effect of mild or moderate hepatic impairment on the pharmacokinetics of risdiplam
por: Kletzl, Heidemarie, et al.
Publicado: (2022)

Phase I study of the irreversible fibroblast growth factor receptor 1–4 inhibitor futibatinib in Japanese patients with advanced solid tumors
por: Doi, Toshihiko, et al.
Publicado: (2022)

An Open‐Label, Phase 1 Study to Assess the Effects of Hepatic Impairment on Pomalidomide Pharmacokinetics
por: Li, Yan, et al.
Publicado: (2018)

Pharmacokinetics of Gepotidacin in Subjects With Normal Hepatic Function and Hepatic Impairment
por: Hossain, Mohammad, et al.
Publicado: (2021)

Safety and Pharmacokinetics of Taniborbactam (VNRX-5133) with Cefepime in Subjects with Various Degrees of Renal Impairment
por: Dowell, James A., et al.
Publicado: (2022)

Maribavir Pharmacokinetics and Safety in Participants With Moderate Hepatic Impairment: A Phase 1, Open‐Label, Single‐Dose, Parallel Group Study
por: Song, Ivy, et al.
Publicado: (2022)

The Effect of Renal Impairment on the Pharmacokinetics and Safety of Itacitinib
por: Srinivas, Nithya, et al.
Publicado: (2020)

705. Pharmacokinetics (PK) and Safety of Lefamulin (LEF) After Single Intravenous Dose Administration in Subjects With Impaired Renal Function and in Those Requiring Hemodialysis
por: Wicha, Wolfgang, et al.
Publicado: (2019)

Cannot write session to /tmp/vufind_sessions/sess_skl26jdocopekt09s56m6pmi86