{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,4,8]],"date-time":"2025-04-08T04:04:52Z","timestamp":1744085092002,"version":"3.40.3"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2025,3,18]],"date-time":"2025-03-18T00:00:00Z","timestamp":1742256000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2025,3,18]],"date-time":"2025-03-18T00:00:00Z","timestamp":1742256000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"funder":[{"name":"Capital\u2019s Funds for Health Improvement and Research","award":["2022-2Z-4056"],"award-info":[{"award-number":["2022-2Z-4056"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Drug Investig"],"published-print":{"date-parts":[[2025,4]]},"DOI":"10.1007\/s40261-025-01430-1","type":"journal-article","created":{"date-parts":[[2025,3,18]],"date-time":"2025-03-18T18:01:01Z","timestamp":1742320861000},"page":"201-206","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Effect of Food on the Pharmacokinetic Characteristics of a Single Oral Dose of D-1553, a Selective Inhibitor of KRASG12C, in Healthy Chinese Subjects"],"prefix":"10.1007","volume":"45","author":[{"given":"Yue","family":"Liu","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xin","family":"Gao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yang","family":"Li","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xuemei","family":"He","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhe","family":"Shi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ling","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yaolin","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9106-7643","authenticated-orcid":false,"given":"Aixin","family":"Shi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2025,3,18]]},"reference":[{"issue":"1","key":"1430_CR1","doi-asserted-by":"crossref","first-page":"386","DOI":"10.1038\/s41392-021-00780-4","volume":"6","author":"L Huang","year":"2021","unstructured":"Huang L, Guo Z, Wang F, Fu L. KRAS mutation: from undruggable to druggable in cancer. Signal Transduct Target Ther. 2021;6(1):386.","journal-title":"Signal Transduct Target Ther"},{"issue":"4","key":"1430_CR2","doi-asserted-by":"crossref","first-page":"850","DOI":"10.1016\/j.cell.2020.09.044","volume":"183","author":"D Kim","year":"2020","unstructured":"Kim D, Xue JY, Lito P. Targeting KRAS(G12C): from inhibitory mechanism to modulation of antitumor effects in patients. Cell. 2020;183(4):850\u20139.","journal-title":"Cell"},{"issue":"8","key":"1430_CR3","doi-asserted-by":"crossref","first-page":"2209","DOI":"10.1158\/1078-0432.CCR-20-4023","volume":"27","author":"KC Arbour","year":"2021","unstructured":"Arbour KC, Rizvi H, Plodkowski AJ, et al. Treatment outcomes and clinical characteristics of patients with KRAS-G12C-mutant non-small cell lung cancer. Clin Cancer Res. 2021;27(8):2209\u201315.","journal-title":"Clin Cancer Res"},{"issue":"7781","key":"1430_CR4","doi-asserted-by":"crossref","first-page":"217","DOI":"10.1038\/s41586-019-1694-1","volume":"575","author":"J Canon","year":"2019","unstructured":"Canon J, Rex K, Saiki AY, et al. The clinical KRAS(G12C) inhibitor AMG 510 drives anti-tumour immunity. Nature. 2019;575(7781):217\u201323.","journal-title":"Nature"},{"issue":"6","key":"1430_CR5","doi-asserted-by":"crossref","first-page":"990","DOI":"10.1016\/j.jtho.2021.02.016","volume":"16","author":"SP Finn","year":"2021","unstructured":"Finn SP, Addeo A, Dafni U, et al. Prognostic impact of KRAS G12C mutation in patients With NSCLC: results from the European thoracic oncology platform lungscape project. J Thorac Oncol. 2021;16(6):990\u20131002.","journal-title":"J Thorac Oncol"},{"issue":"10","key":"1430_CR6","doi-asserted-by":"crossref","first-page":"1513","DOI":"10.1097\/JTO.0000000000000305","volume":"9","author":"E Nadal","year":"2014","unstructured":"Nadal E, Chen G, Prensner JR, et al. KRAS-G12C mutation is associated with poor outcome in surgically resected lung adenocarcinoma. J Thorac Oncol. 2014;9(10):1513\u201322.","journal-title":"J Thorac Oncol"},{"issue":"8","key":"1430_CR7","doi-asserted-by":"crossref","first-page":"3992","DOI":"10.1158\/0008-5472.CAN-06-0191","volume":"66","author":"A Lievre","year":"2006","unstructured":"Lievre A, Bachet JB, Le Corre D, et al. KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer. Cancer Res. 2006;66(8):3992\u20135.","journal-title":"Cancer Res"},{"issue":"25","key":"1430_CR8","doi-asserted-by":"publisher","first-page":"5076","DOI":"10.1038\/s41388-019-0780-z","volume":"38","author":"PA Clarke","year":"2019","unstructured":"Clarke PA, Roe T, Swabey K, et al. Dissecting mechanisms of resistance to targeted drug combination therapy in human colorectal cancer. Oncogene. 2019;38(25):5076\u201390. https:\/\/doi.org\/10.1038\/s41388-019-0780-z.","journal-title":"Oncogene"},{"issue":"7","key":"1430_CR9","doi-asserted-by":"crossref","first-page":"2951","DOI":"10.1111\/cas.15829","volume":"114","author":"Z Shi","year":"2023","unstructured":"Shi Z, Weng J, Niu H, et al. D-1553: a novel KRAS(G12C) inhibitor with potent and selective cellular and in vivo antitumor activity. Cancer Sci. 2023;114(7):2951\u201360.","journal-title":"Cancer Sci"},{"issue":"1","key":"1430_CR10","doi-asserted-by":"crossref","first-page":"52","DOI":"10.1021\/acs.jmedchem.9b01180","volume":"63","author":"BA Lanman","year":"2020","unstructured":"Lanman BA, Allen JR, Allen JG, et al. Discovery of a covalent inhibitor of KRAS(G12C) (AMG 510) for the treatment of solid tumors. J Med Chem. 2020;63(1):52\u201365.","journal-title":"J Med Chem"},{"issue":"13","key":"1430_CR11","doi-asserted-by":"crossref","first-page":"6679","DOI":"10.1021\/acs.jmedchem.9b02052","volume":"63","author":"JB Fell","year":"2020","unstructured":"Fell JB, Fischer JP, Baer BR, et al. Identification of the clinical development candidate MRTX849, a covalent KRAS(G12C) inhibitor for the treatment of cancer. J Med Chem. 2020;63(13):6679\u201393.","journal-title":"J Med Chem"},{"issue":"13","key":"1430_CR12","doi-asserted-by":"crossref","first-page":"1056","DOI":"10.1158\/1538-7445.AM2021-1056","volume":"81","author":"Z Shi","year":"2021","unstructured":"Shi Z, Weng J, Fan X, et al. Potent in vivo anti-tumor activity of D-1553 as a single agent and in combination with targeted therapeutics in a broad spectrum of patient-derived xenograft tumor models with KRas G12C mutation. Cancer Res. 2021;81(13):1056\u20131056.","journal-title":"Cancer Res"},{"key":"1430_CR13","volume-title":"Garsorasib prescribing information [Package Insert]","author":"Garsorasib","year":"2024","unstructured":"Garsorasib. Garsorasib prescribing information [Package Insert]. Ltd: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co.; 2024."},{"key":"1430_CR14","doi-asserted-by":"crossref","first-page":"234","DOI":"10.1016\/j.ejpb.2016.11.034","volume":"112","author":"AY Abuhelwa","year":"2017","unstructured":"Abuhelwa AY, Williams DB, Upton RN, Foster DJ. Food, gastrointestinal pH, and models of oral drug absorption. Eur J Pharm Biopharm. 2017;112:234\u201348.","journal-title":"Eur J Pharm Biopharm"},{"key":"1430_CR15","unstructured":"U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry: Food-Effect Bioavailability and Fed Bioequivalence Studies."},{"issue":"8","key":"1430_CR16","doi-asserted-by":"crossref","first-page":"589","DOI":"10.1016\/S2213-2600(24)00110-3","volume":"12","author":"Z Li","year":"2024","unstructured":"Li Z, Dang X, Huang D, et al. Garsorasib in patients with KRASG12C-mutated non-small-cell lung cancer in China: an open-label, multicentre, single-arm, phase 2 trial. Lancet Resp Med. 2024;12(8):589\u201398.","journal-title":"Lancet Resp Med."},{"issue":"10","key":"1430_CR17","doi-asserted-by":"crossref","first-page":"S40","DOI":"10.1016\/j.jtho.2024.09.072","volume":"19","author":"Z Li","year":"2024","unstructured":"Li Z, Lu S, Dang X, et al. Garsorasib in KRAS G12C - mutated non-small-cell lung cancer: updated results from a phase 2 study. J Thorac Oncol. 2024;19(10):S40\u20131.","journal-title":"J Thorac Oncol"},{"issue":"7","key":"1430_CR18","doi-asserted-by":"crossref","first-page":"940","DOI":"10.1016\/j.jtho.2023.03.015","volume":"18","author":"Z Li","year":"2023","unstructured":"Li Z, Song Z, Zhao Y, et al. D-1553 (Garsorasib), a potent and selective inhibitor of KRAS(G12C) in patients with NSCLC: phase 1 study results. J Thorac Oncol. 2023;18(7):940\u201351.","journal-title":"J Thorac Oncol"},{"key":"1430_CR19","unstructured":"US FDA. LUMAKRAS\u2122 (sotorasib) product insert. 2021. Available from:https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/214665s000lbl.pdf. Accessed 5 Feb 2024"},{"key":"1430_CR20","unstructured":"US FDA. KRAZATI\u2122 (adagrasib) product insert. 2022. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/216340Orig1s000Corrected_lbl.pdf. Accessed 5 Feb 2024."}],"container-title":["Clinical Drug Investigation"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40261-025-01430-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40261-025-01430-1\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40261-025-01430-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,7]],"date-time":"2025-04-07T05:00:10Z","timestamp":1744002010000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40261-025-01430-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,3,18]]},"references-count":20,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2025,4]]}},"alternative-id":["1430"],"URL":"https:\/\/doi.org\/10.1007\/s40261-025-01430-1","relation":{},"ISSN":["1173-2563","1179-1918"],"issn-type":[{"type":"print","value":"1173-2563"},{"type":"electronic","value":"1179-1918"}],"subject":[],"published":{"date-parts":[[2025,3,18]]},"assertion":[{"value":"24 February 2025","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 March 2025","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study was funded by Capital\u2019s Funds for Health Improvement and Research, 2022-2Z-4056. All authors had full access to all of the study data and took complete responsibility for the integrity of the data and accuracy of the data analysis.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Zhe Shi, Ling Zhang, and Yaolin Wang are employees of R&D, InventisBio Co., Ltd. No potential confict of interest was reported by the other authors.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This study protocol had been approved by the Beijing Hospital Ethics Committee (no.2021BJYYEC-244-01; approval date: 30 Sept 2021) and was conducted in accordance with the Declaration of Helsinki and International Council for Harmonisation (ICH) guidelines for Good Clinical Practice (GCP).","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All participants gave their written informed consent for participation in this study.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"The informed consent form included a disclaimer that data will be anonymized and published.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to publish"}},{"value":"The data that support the findings of this study are available from the corresponding author upon reasonable request.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data availability"}},{"value":"Not applicable. This study did not involve the use of any specific software application or custom code for data analysis or experimental procedures. All statistical analyses were performed using standard commercial software packages with built-in functions and no custom coding was necessary.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"LY, ZS, LZ, YW, and AS contributed to the study design. XG, YL, and XH contributed to the data collection. ZS, LZ, and LY performed the statistical analyses and interpretation and drafted the manuscript. YW and AS revised the manuscript. All authors contributed to the critical revision of the manuscript and approved its final version. Financial support and study supervision were provided by ZS, LZ, and YW.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions conceptualization"}}]}}