Evidence map›Paper›PMID 38112942›Full record

Trial reportClinical drug investigation2024

Food Effect on the Pharmacokinetics of VC004, a Tropomyosin Receptor Kinase Inhibitor: A Randomized Crossover Trial in Healthy Chinese Subjects.

Linlin Hu, Qiuyue Sun, Lu Tang, Mingmin Cai, Wei Qian, Ting Dou, Huiping Wang, Yong Wu, Yongqiang Liu

Abstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Publisher
In one paragraph

Trial report in Clinical drug investigation, 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
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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

9 authors.

Linlin HuDepartment of Pharmacy, Nanjing Zhongda Hospital, School of Medicine, Southeast University, Nanjing, 210009, China. eliza50@sina.com.ORCID http://orcid.org/0000-0002-7545-5195
Qiuyue SunDepartment of Phase I Clinical Trial Unit, Nanjing Zhongda Hospital, School of Medicine, Southeast University, Nanjing, 210009, China.
Lu TangDepartment of Phase I Clinical Trial Unit, Nanjing Zhongda Hospital, School of Medicine, Southeast University, Nanjing, 210009, China.
Mingmin CaiDepartment of Phase I Clinical Trial Unit, Nanjing Zhongda Hospital, School of Medicine, Southeast University, Nanjing, 210009, China.
Wei QianDepartment of Phase I Clinical Trial Unit, Nanjing Zhongda Hospital, School of Medicine, Southeast University, Nanjing, 210009, China.
Ting DouDepartment of Phase I Clinical Trial Unit, Nanjing Zhongda Hospital, School of Medicine, Southeast University, Nanjing, 210009, China.
Huiping WangDepartment of Phase I Clinical Trial Unit, Nanjing Zhongda Hospital, School of Medicine, Southeast University, Nanjing, 210009, China.
Yong WuJiangsu Vcare PharmaTech Co., Ltd., Nanjing, China.
Yongqiang LiuJiangsu Vcare PharmaTech Co., Ltd., Nanjing, China.

Funding

Basic Research Program of Jiangsu Province BK20150645Shijiazhuang Pharmaceutical Foundation of Jiangsu Pharmaceutical Association No. SY202306-4the CHIA TAI TIAQING Pharmaceutical Foundation of Jiangsu Pharmaceutical Association No. Q202203the National Natural Science Foundation of China No. 81503340
6 · The paper itself

Abstract

BACKGROUND AND

objectiveVC004 is a novel next-generation tropomyosin receptor kinase (TRK) inhibitor that is approved for the treatment of advanced or metastatic NTRK fusion-positive solid tumors and abrogated the drug resistance of the first-generation TRK inhibitors. The objective of the present study was to evaluate the effect of food on the pharmacokinetics and safety of VC004.

methodsThe study was a randomized, open-label, two-period crossover, single-dose, phase I clinical trial. A total of 16 healthy subjects participated the trial. Subjects fasted for 10 h before drug administration in both fasting and fed states. Subjects received VC004 50 mg orally in the fasting state and after a high caloric food in the fed state. Blood samples at the designated time points were collected to determine the plasma concentration of VC004. Safety evaluation in both the fasted and fed periods were assessed via vital sign monitoring and clinical laboratory tests.

resultsThe maximum plasma concentration (C

conclusionsThe intake of high calorie food decreased the absorption rate and increased the T

trial registrationClinicalTrials.gov ID: NCT055528120.

Indexed as

FastingTropomyosinAdministration, OralArea Under CurveChinaCross-Over StudiesFood-Drug InteractionsHealthy VolunteersHumansTabletsTherapeutic EquivalencyTabletsTropomyosin

Identifiers

PMID38112942

What OpenQuestion holds

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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.