Evidence map›Paper›PMID 41894126›Full record

Trial reportInvestigational new drugs2026

Clinical pharmacokinetic characteristics and the food effect of radotinib.

Yerin Lee, Jiwon Kim, Minseo Kang, Jiwon Han, Na Yun Kim, Jae Soo Shin, Min Soo Park, Qian Jiang, Jangik I Lee

Abstract readClinical Trial, Phase IClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2026. 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

9 authors.

Yerin Lee *College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Republic of Korea.ORCID http://orcid.org/0009-0006-1543-3783
Jiwon Kim *College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Republic of Korea.ORCID http://orcid.org/0009-0009-2433-4228
Minseo KangCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Republic of Korea.ORCID http://orcid.org/0009-0006-6818-5226
Jiwon HanCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Republic of Korea.
Na Yun KimIL-YANG Pharmaceutical Co., Ltd, Yongin, Republic of Korea.
Jae Soo ShinIL-YANG Pharmaceutical Co., Ltd, Yongin, Republic of Korea.ORCID http://orcid.org/0009-0005-7227-9551
Min Soo ParkDepartment of Clinical Pharmacology, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0002-4395-9938
Qian JiangPeking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing, China.ORCID http://orcid.org/0000-0001-7131-0522
Jangik I LeeCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Republic of Korea. jangik.lee@snu.ac.kr.ORCID http://orcid.org/0000-0002-5565-8323

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Radotinib is a second-generation tyrosine kinase inhibitor that selectively targets BCR-ABL1 and is used for the treatment of chronic myeloid leukemia (CML). This study aimed to evaluate the clinical pharmacokinetic characteristics and the food effect of radotinib. Healthy volunteers received a single oral dose of radotinib 400 mg under fasted or fed conditions in a crossover manner, and CML patients received repeated oral doses of 300 mg twice daily. The pharmacokinetic characteristics were evaluated by a noncompartmental method, using plasma concentration-time data following a single administration in healthy volunteers, and on Days 1 and 14 in CML patients. The food effect was assessed by comparing the pharmacokinetic parameters under fed and fasted conditions in healthy volunteers. The pharmacokinetic analyses of radotinib included data from 23 healthy male volunteers and 24 patients newly diagnosed with CML. In both populations, the plasma concentrations of radotinib peaked at approximately 3 h. In healthy volunteers, the concentrations declined biexponentially with the terminal half-life (t

Indexed as

Antineoplastic AgentsBenzamidesFood-Drug InteractionsLeukemia, Myelogenous, Chronic, BCR-ABL PositiveProtein Kinase InhibitorsPyrazinesAdministration, OralAdultAgedCross-Over StudiesFastingFemaleHumansMaleMiddle AgedYoung Adult4-methyl-N-(3-(4-methylimidazol-1-yl)-5-trifluoromethylphenyl)-3-(4-pyrazin-2-ylpyrimidin-2-ylamino)benzamideAntineoplastic AgentsBenzamidesProtein Kinase InhibitorsPyrazinesChronic myeloid leukemiaClinical pharmacokineticsFood effectRadotinibTyrosine kinase inhibitor

Identifiers

PMID41894126

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.