Evidence map›Paper›PMID 38602625›Full record

Trial reportInvestigational new drugs2024

The effect of food on the pharmacokinetics of Sutetinib maleate capsule, an irreversible EGFR tyrosine kinase inhibitor, in healthy Chinese subjects.

Bei Cao, Tingting Ma, Yuqiang Zhang, Lei Huang, Hui Lin, Huanhuan Jiang, Yu Zhao, Yan Geng, Yuanxun Yang, Sumin Cao and 1 more

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

11 authors.

Bei CaoPhase I Clinical Trials Unit, Affiliated Hospital of Medical School, Nanjing Drum Tower Hospital, Nanjing University, Zhongshan Road 321#, Gulou District, 210008, Nanjing, China.
Tingting MaPhase I Clinical Trials Unit, Affiliated Hospital of Medical School, Nanjing Drum Tower Hospital, Nanjing University, Zhongshan Road 321#, Gulou District, 210008, Nanjing, China.
Yuqiang ZhangClinical Pharmacology Department, Suzhong pharmaceutical group co., LTD, 22550, Taizhou, China.
Lei HuangPhase I Clinical Trials Unit, Affiliated Hospital of Medical School, Nanjing Drum Tower Hospital, Nanjing University, Zhongshan Road 321#, Gulou District, 210008, Nanjing, China.
Hui LinPhase I Clinical Trials Unit, Affiliated Hospital of Medical School, Nanjing Drum Tower Hospital, Nanjing University, Zhongshan Road 321#, Gulou District, 210008, Nanjing, China.
Huanhuan JiangClinical Pharmacology Department, Suzhong pharmaceutical group co., LTD, 22550, Taizhou, China.
Yu ZhaoPhase I Clinical Trials Unit, Affiliated Hospital of Medical School, Nanjing Drum Tower Hospital, Nanjing University, Zhongshan Road 321#, Gulou District, 210008, Nanjing, China.
Yan GengPhase I Clinical Trials Unit, Affiliated Hospital of Medical School, Nanjing Drum Tower Hospital, Nanjing University, Zhongshan Road 321#, Gulou District, 210008, Nanjing, China.
Yuanxun YangPhase I Clinical Trials Unit, Affiliated Hospital of Medical School, Nanjing Drum Tower Hospital, Nanjing University, Zhongshan Road 321#, Gulou District, 210008, Nanjing, China.
Sumin CaoClinical Pharmacology Department, Suzhong pharmaceutical group co., LTD, 22550, Taizhou, China. caosm@suzhongyy.com.
Juan LiPhase I Clinical Trials Unit, Affiliated Hospital of Medical School, Nanjing Drum Tower Hospital, Nanjing University, Zhongshan Road 321#, Gulou District, 210008, Nanjing, China. juanli2003@163.com.

Funding

Funding for Clinical Trials from Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School 2022-LCYJ-PY-19Natural Science Foundation of Nanjing University of Chinese Medicine XZR2020055
6 · The paper itself

Abstract

Sutetinib is an irreversible inhibitor of epidermal growth factor receptor (EGFR) and showed favorable efficacy and safety in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring nondrug-resistant rare EGFR mutations. To evaluate the potential food effect, eighteen healthy Chinese subjects were enrolled in a single-centre, randomized, open-label, two-sequence, two-period crossover study. Sutetinib was administered as a single oral 100 mg under fasting or fed conditions, and pharmacokinetic sampling was performed following each dose and analysed by a validated liquid chromatography/mass spectrometry method. Safety and tolerability were also evaluated. Food intake slightly decreased maximum plasma concentration (C

Indexed as

Cross-Over StudiesErbB ReceptorsFood-Drug InteractionsHealthy VolunteersProtein Kinase InhibitorsAdultCapsulesEast Asian PeopleFemaleHumansMaleMiddle AgedTyrosine Kinase InhibitorsYoung AdultCapsulesEGFR protein, humanErbB ReceptorsProtein Kinase InhibitorsTyrosine Kinase InhibitorsEGFR tyrosine kinase inhibitorFood effectLung cancerPharmacokineticsSutetinib

Identifiers

What OpenQuestion holds

Textmetadata
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.