Evidence map›Paper›PMID 35841331›Full record

ArticleCancer medicine2023

Study on pharmacokinetic interactions between SHR2554 and itraconazole in healthy subjects: A single-center, open-label phase I trial.

Kunhong Deng, Yi Zou, Chan Zou, Hong Wang, Yuxia Xiang, Xiaoyan Yang, Shuang Yang, Chang Cui, Guoping Yang, Jie Huang

Open access · goldAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancer medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.2field-weighted citation impact, top 23% of its field
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

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
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  3. Epigenetics-targeted drugs: current paradigms and future challenges.Signal transduction and targeted therapy · 2024
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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

10 authors at 1 institution in 1 country.

Kunhong DengCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Yi ZouSchool of Mathematics and Statistics, Central South University, Changsha, China.
Chan ZouCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Hong WangSchool of Mathematics and Statistics, Central South University, Changsha, China.
Yuxia XiangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Xiaoyan YangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Shuang YangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Chang CuiCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Guoping YangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.ORCID 0000-0001-5930-586X
Jie HuangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Central South University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSHR2554, a novel oral Enhancer of Zeste Homolog 2 inhibitor, shows broad-spectrum anti-tumor efficacy in preclinical studies. As SHR2554 is mainly metabolized by CYP3A4, it is helpful to conduct research on the effects of itraconazole, a strong inhibitor of CYP3A4-metabolizing enzymes, on the pharmacokinetic characteristics and safety of SHR2554.

methodsWe conducted a single-center, open-label pharmacokinetic study of itraconazole on SHR2554 in 18 healthy Chinese subjects. Subjects were orally administrated SHR2554 50 mg on Day 1, itraconazole 200 mg Quaque Die (QD) from Days 4 to 7, SHR2554 50 mg co-administrated with itraconazole 200 mg on Day 8, and itraconazole 200 mg QD from Days 9 to 12. Then, 4 ml of venous blood was collected at predetermined time points. Plasma SHR2554 concentrations were analyzed using a validated high-performance liquid chromatography tandem mass spectrometry method. Pharmacokinetic parameters were calculated using Phoenix WinNonlin v8.1.

resultsThe C

conclusionsCompared with a single dose of SHR2554 50 mg, the exposure of SHR2554 in vivo was significantly affected by the combined administration of itraconazole.

Indexed as

ItraconazoleNeoplasmsArea Under CurveCross-Over StudiesCytochrome P-450 CYP3AEnzyme InhibitorsHealthy VolunteersHumansCytochrome P-450 CYP3AEnzyme InhibitorsItraconazoledrug-drug interactionEZH2 inhibitoritraconazolepharmacokineticsSHR2554

Identifiers

PMID35841331
PMCPMC9883540
OpenAlexW4285587663

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LicenceCC BY
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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.