Evidence map›Paper›PMID 34164501›Full record

ArticleAnnals of translational medicine2021

Absorption, metabolism, excretion, and safety of [

Chen Zhou, Lijun Xie, Wei Liu, Lingling Zhang, Sufeng Zhou, Lu Wang, Juan Chen, Huan Li, Yuqing Zhao, Bei Zhu and 3 more

Abstract read
In one paragraph

Article in Annals of translational medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

10 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. Almonertinib plus chemotherapyFrontiers in oncology · 2023
    Article
  8. Review
  9. Article
  10. 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

13 authors.

Chen ZhouPhase I Clinical Trial Unit, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Lijun XiePhase I Clinical Trial Unit, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Wei LiuNuclear Medicine Department, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Lingling ZhangLab Testing Division, Department of DMPK Service, WuXi AppTec Co., Ltd., Nanjing, China.
Sufeng ZhouPhase I Clinical Trial Unit, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Lu WangPhase I Clinical Trial Unit, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Juan ChenPhase I Clinical Trial Unit, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Huan LiLab Testing Division, Department of DMPK Service, WuXi AppTec Co., Ltd., Nanjing, China.
Yuqing ZhaoPhase I Clinical Trial Unit, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Bei ZhuPhase I Clinical Trial Unit, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Sijia DingPhase I Clinical Trial Unit, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Chen ZhangNuclear Medicine Department, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Feng ShaoPhase I Clinical Trial Unit, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlmonertinib Mesilate Tablets (HS-10296, Hansoh Pharma, Shanghai, China) is a novel and selective third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). A phase I study of almonertinib in patients with non-small cell lung cancer (NSCLC) demonstrated a linear metabolic trend, a good tolerability/safety profile, and preliminary antitumor activity. However, the metabolism, excretion, and substance balance of almonertinib has not been clearly determined. Here, we investigated the pharmacokinetic characteristics and safety profile of almonertinib following a single oral dose (110 mg/50 µCi) in healthy Chinese male participants.

methodsTotal radioactivity (TRA) in whole blood, plasma, urine, and feces was measured by utilizing a liquid scintillation counter to obtain almonertinib substance balance data. The pharmacokinetic parameters of [

resultsThe safety and tolerability of a single oral dose of 110 mg/50 µCi [

conclusionsAlmonertinib has a good safety profile, with parent drug as its main circulating component. almonertinib is extensively metabolized

trial registrationThe trial registration number: CTR20192291.

Indexed as

14CAlmonertinibexcretionHS-10296metabolismpharmacokinetics

Identifiers

PMID34164501
PMCPMC8184462

What OpenQuestion holds

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Registered trials

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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.