Evidence map›Paper›PMID 37553804›Full record

ArticleClinical and translational science2023

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

Ling Gao, Ikuo Yamamiya, Mark Pinti, Juan Carlos Rondon, Thomas Marbury, Gareth Tomlinson, Lukas Makris, Nanae Hangai, Volker Wacheck

Abstract readClinical Trial, Phase I
In one paragraph

Article in Clinical and translational science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Ling GaoTaiho Oncology, Inc., Princeton, New Jersey, USA.
Ikuo YamamiyaTaiho Pharmaceutical Co., Ltd., Tsukuba, Japan.
Mark PintiTaiho Oncology, Inc., Princeton, New Jersey, USA.
Juan Carlos RondonClinical Pharmacology of Miami, Hialeah, Florida, USA.
Thomas MarburyOrlando Clinical Research Center, Orlando, Florida, USA.ORCID 0000-0002-6416-3314
Gareth TomlinsonTaiho Oncology, Inc., Princeton, New Jersey, USA.
Lukas MakrisTaiho Oncology, Inc., Princeton, New Jersey, USA.
Nanae HangaiTaiho Oncology, Inc., Princeton, New Jersey, USA.
Volker WacheckTaiho Oncology, Inc., Princeton, New Jersey, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 (PKs), safety, and tolerability of futibatinib in subjects with impaired hepatic function and matched healthy volunteers. Twenty-two subjects with hepatic impairment (8 mild [Child-Pugh 5-6], 8 moderate [7-9], and 6 severe [10-15]) and 16 matched healthy control subjects received a single oral dose of futibatinib 20 mg. Futibatinib PKs were compared between subjects with mild/moderate/severe hepatic impairment and each corresponding control cohort and the overall control cohort. Relationships between futibatinib PKs and Child-Pugh scores and liver function tests were examined via scatter/regression plots. Compared with matched controls, the area under the plasma concentration-time curve from time zero to infinity increased by 21%/20%/18% and the maximum plasma concentration (C

Indexed as

Liver DiseasesArea Under CurveHumansPyrazolesPyrimidinesPyrrolesfutibatinibPyrazolesPyrimidinesPyrroles

Identifiers

PMID37553804
PMCPMC10499415

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.