Evidence map›Paper›PMID 39533673›Full record

ArticleClinical and translational science2024

Evaluation of drug-drug interactions of a novel potent FLT3 inhibitor SKLB1028 in healthy subjects.

Jingcheng Chen, Jingxuan Wu, Nini Guo, Yuqin Song, Lijun Li, Bingyan Wang, Jiangshuo Li, Mengyu Hou, Hang Yin, Meijuan Zhang and 6 more

Abstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical and translational science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. 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

16 authors.

Jingcheng ChenBeijing Friendship Hospital, Capital Medical University, Beijing, China.ORCID 0000-0002-1199-9599
Jingxuan WuBeijing Friendship Hospital, Capital Medical University, Beijing, China.
Nini GuoCSPC Zhongqi Pharmaceutical Technology (SJZ) Co., Ltd., Shijiazhuang, Hebei Province, China.
Yuqin SongBeijing Friendship Hospital, Capital Medical University, Beijing, China.
Lijun LiBeijing Friendship Hospital, Capital Medical University, Beijing, China.
Bingyan WangBeijing Friendship Hospital, Capital Medical University, Beijing, China.
Jiangshuo LiBeijing Friendship Hospital, Capital Medical University, Beijing, China.
Mengyu HouBeijing Friendship Hospital, Capital Medical University, Beijing, China.
Hang YinBeijing Friendship Hospital, Capital Medical University, Beijing, China.
Meijuan ZhangBeijing Friendship Hospital, Capital Medical University, Beijing, China.
Yanhong KongBeijing Friendship Hospital, Capital Medical University, Beijing, China.
Xiaofang WuBeijing Friendship Hospital, Capital Medical University, Beijing, China.
Ran LiBeijing Friendship Hospital, Capital Medical University, Beijing, China.
Le WuBeijing Friendship Hospital, Capital Medical University, Beijing, China.
Qiannan GaoBeijing Friendship Hospital, Capital Medical University, Beijing, China.
Ruihua DongBeijing Friendship Hospital, Capital Medical University, Beijing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

SKLB1028 is a novel multi-target protein kinase inhibitor under investigation for the treatment of FLT3-ITD mutated acute myeloid leukemia. Based on the preclinical characterization of SKLB1028 metabolism, three drug-drug interaction clinical studies were performed to investigate the effects of itraconazole, rifampin (CYP3A4 inhibitor and inducer, respectively), and gemfibrozil (CYP2C8 inhibitor) on the metabolism of SKLB1028. Fourteen healthy Chinese male subjects were enrolled in each study. In Study 1, subjects were administered a single dose of SKLB1028 (100 mg on days 1 and 11) and multiple doses of itraconazole (200 mg twice daily on day 8 and 200 mg once daily from days 9 to 18). Itraconazole was given with a loading dose on Day 8 and the total administration of itraconazole was 11 days. In Study 2, subjects were administered a single dose of SKLB1028 (100 mg on days 1 and 12) and multiple doses of gemfibrozil (600 mg twice daily from days 8 to 19). In Study 3, subjects were administered a single dose of SKLB1028 (150 mg on days 1 and 15) and multiple doses of rifampin (600 mg once daily from day 8 to 22). Itraconazole increased the AUC and C

Indexed as

Drug Interactionsfms-Like Tyrosine Kinase 3GemfibrozilHealthy VolunteersItraconazoleProtein Kinase InhibitorsRifampinAdultAniline CompoundsArea Under CurveCytochrome P-450 CYP2C8 InhibitorsCytochrome P-450 CYP3A InducersCytochrome P-450 CYP3A InhibitorsHumansMalePyrazinesAniline CompoundsCytochrome P-450 CYP2C8 InhibitorsCytochrome P-450 CYP3A InducersCytochrome P-450 CYP3A InhibitorsFLT3 protein, humanfms-Like Tyrosine Kinase 3GemfibrozilgilteritinibItraconazoleProtein Kinase InhibitorsPyrazinesRifampin

Identifiers

PMID39533673
PMCPMC11557726

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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.