Evidence map›Paper›PMID 38789848›Full record

ArticleInvestigational new drugs2024

A phase 1 study to assess the absolute bioavailability, mass balance, pharmacokinetics, metabolism, and excretion of [

Michael J Hanley, Steven Zhang, Robert Griffin, Sean Xiaochun Zhu, Robert J Fram, Jianchang Lin, Karthik Venkatakrishnan, Neeraj Gupta

Abstract readClinical Trial, Phase I
In one paragraph

Article in Investigational new drugs, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

8 authors.

Michael J HanleyQuantitative Clinical Pharmacology, Takeda Development Center Americas, Inc, Lexington, MA, USA. Michael.Hanley@takeda.com.ORCID 0000-0001-9266-2797
Steven ZhangQuantitative Clinical Pharmacology, Takeda Development Center Americas, Inc, Lexington, MA, USA.
Robert GriffinGlobal DMPK, Takeda Development Center Americas, Inc, Lexington, MA, USA.ORCID 0000-0002-1907-2421
Sean Xiaochun ZhuGlobal DMPK, Takeda Development Center Americas, Inc, Lexington, MA, USA.ORCID 0009-0006-7937-812X
Robert J FramClinical Science, Takeda Development Center Americas, Inc, Lexington, MA, USA.ORCID 0000-0001-7216-3130
Jianchang LinStatistical & Quantitative Sciences, Takeda Development Center Americas, Inc, Lexington, MA, USA.
Karthik VenkatakrishnanQuantitative Pharmacology, EMD Serono Research & Development Institute, Inc, Billerica, MA, USA.ORCID 0000-0003-4039-9813
Neeraj GuptaQuantitative Clinical Pharmacology, Takeda Development Center Americas, Inc, Lexington, MA, USA.ORCID 0000-0002-5500-5218

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Mobocertinib (TAK-788) is a first-in-class oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that received accelerated approval for the treatment of patients with non-small cell lung cancer with EGFR exon 20 insertion mutations previously treated with platinum-based chemotherapy. This phase 1, 2-period, study was conducted to assess the absolute bioavailability of mobocertinib (Period 1), as well as mass balance, pharmacokinetics, metabolism, and excretion of [

Indexed as

Aniline CompoundsCarbon RadioisotopesErbB ReceptorsExonsHealthy VolunteersMutagenesis, InsertionalProtein Kinase InhibitorsAdministration, OralAdultBiological AvailabilityHumansIndolesMaleMiddle AgedPyrimidinesYoung AdultAniline CompoundsCarbon RadioisotopesEGFR protein, humanErbB ReceptorsIndolesmobocertinibProtein Kinase InhibitorsPyrimidinesADMEEGFRExon 20 insertion mutationLung cancerMobocertinibTyrosine kinase inhibitor

Identifiers

PMID38789848
PMCPMC11327196

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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 OpenQuestion graph.