Evidence map›Paper›PMID 40102370›Full record

Trial reportClinical drug investigation2025

Effect of Food on the Pharmacokinetic Characteristics of a Single Oral Dose of D-1553, a Selective Inhibitor of KRAS

Yue Liu, Xin Gao, Yang Li, Xuemei He, Zhe Shi, Ling Zhang, Yaolin Wang, Aixin Shi

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical drug investigation, 2025. 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

8 authors.

Yue LiuClinical Trial Center, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Key Laboratory for Artificial Intelligence and Biotechnology Collaboratories in Gerontology Research, Beijing, People's Republic of China.
Xin GaoClinical Trial Center, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Key Laboratory for Artificial Intelligence and Biotechnology Collaboratories in Gerontology Research, Beijing, People's Republic of China.
Yang LiClinical Trial Center, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Key Laboratory for Artificial Intelligence and Biotechnology Collaboratories in Gerontology Research, Beijing, People's Republic of China.
Xuemei HeClinical Trial Center, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Key Laboratory for Artificial Intelligence and Biotechnology Collaboratories in Gerontology Research, Beijing, People's Republic of China.
Zhe ShiR&D, InventisBio Co., Ltd, Shanghai, People's Republic of China.
Ling ZhangR&D, InventisBio Co., Ltd, Shanghai, People's Republic of China.
Yaolin WangR&D, InventisBio Co., Ltd, Shanghai, People's Republic of China.
Aixin ShiClinical Trial Center, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Key Laboratory for Artificial Intelligence and Biotechnology Collaboratories in Gerontology Research, Beijing, People's Republic of China. aixins0302@126.com.ORCID http://orcid.org/0000-0002-9106-7643

Funding

Capital's Funds for Health Improvement and Research 2022-2Z-4056
6 · The paper itself

Abstract

BACKGROUND AND

objectiveD-1553 (garsorasib) is a novel and selective oral KRAS

methodsA randomized, open-label, single-dose, two-intervention (fed vs fasting), two-period, two-sequence crossover study was performed on 14 healthy Chinese subjects. Plasma concentrations of D-1553 were determined by the liquid chromatography-tandem mass spectrometry method. Safety evaluations were carried out during the study period. The main PK parameters of the two formulations of D-1553 were calculated by non-compartmental analysis using Phoenix WinNonlin (Version 8.3) software.

resultsThe geometric mean ratios (90% confidence interval [CI]) of AUC

conclusionThe study indicated that a high-calorie and high-fat meal has no clinically relevant impact on the PK and bioavailability of D-1553 in healthy Chinese subjects. D-1553 was generally safe and well-tolerated under both fasting and fed conditions. The findings suggest that D-1553 could be administered orally with or without food. CLINICAL TRIALS: ClinicalTrials.gov Identifer CTR20212761; registered on 4 Nov 2021.

Indexed as

Food-Drug InteractionsProto-Oncogene Proteins p21(ras)Administration, OralAdultArea Under CurveCross-Over StudiesEast Asian PeopleFastingFemaleHealthy VolunteersHumansMaleYoung AdultKRAS protein, humanProto-Oncogene Proteins p21(ras)

Identifiers

PMID40102370

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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.