{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T15:37:55Z","timestamp":1792597075836,"version":"4.5.0"},"reference-count":23,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T00:00:00Z","timestamp":1792540800000},"content-version":"vor","delay-in-days":20,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100004330","name":"GlaxoSmithKline","doi-asserted-by":"publisher","award":["222308"],"award-info":[{"award-number":["222308"]}],"id":[{"id":"10.13039\/100004330","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    This Phase I, randomized, placebo\u2010controlled, double\u2010blind study (NCT06625489) evaluated pharmacokinetics (PK), safety, and tolerability of the transglutaminase 2 inhibitor suvigletistat in Chinese, Japanese, and White\/European participants. Eligible participants: aged 18\u201350 years, healthy, and of Chinese, Japanese, or White\/European ancestry. Thirty\u2010six participants (12 per ancestry group) were randomized 3:1 to receive suvigletistat (160\u00a0mg single oral dose) or placebo. Suvigletistat was rapidly absorbed (median time to maximum observed drug concentration [C\n                    <jats:sub>max<\/jats:sub>\n                    ]: 0.67\u20130.75\u00a0h), and geometric mean half\u2010life ranged from 1.93 to 2.58 h across ancestry groups. Suvigletistat systemic exposure was similar across all ancestries; geometric least squares mean ratios versus White\/European participants for C\n                    <jats:sub>max<\/jats:sub>\n                    were 0.99 and 1.06 in participants of Chinese and Japanese ancestry, respectively. Similarly, area under the concentration\u2013time curve from time zero to infinity ratios were 0.94 and 1.06. Suvigletistat geometric mean elimination half\u2010life was comparable in Chinese (1.93 h), Japanese (2.23 h), and White\/European participants (2.58 h). There were no serious adverse events or deaths. There were no clinically meaningful findings in laboratory values, vital signs, or electrocardiograms. No clinically meaningful differences in suvigletistat PK were observed between ancestry groups, providing evidence of low ethnic sensitivity for a drug with cytochrome P450 3A4\u2010dependent metabolism.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70113","type":"journal-article","created":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T14:38:07Z","timestamp":1792593487000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetics and Safety Evaluation of the Transglutaminase 2 Inhibitor Suvigletistat in Healthy Chinese, Japanese, and White\/European Participants"],"prefix":"10.1002","volume":"15","author":[{"given":"Romina A.","family":"Nand","sequence":"first","affiliation":[{"name":"Clinical Pharmacology Pharmacometrics Systems and Tools GSK R&amp;D  Melbourne VIC Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hannah","family":"Woodcock","sequence":"additional","affiliation":[{"name":"Respiratory Immunology &amp; Inflammation Research Unit GSK  Stevenage UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kasia A.","family":"Okrojek\u2010Swiderek","sequence":"additional","affiliation":[{"name":"Safety Evaluation and Risk Management GSK  Pozna\u0144 Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yolanda","family":"Alvarez","sequence":"additional","affiliation":[{"name":"Safety Evaluation and Risk Management GSK  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohak","family":"Sharda","sequence":"additional","affiliation":[{"name":"Early Development Statistics GSK  Bengaluru Karnataka India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anubha","family":"Gupta","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Quantitative Medicine GSK  Stevenage UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,10,21]]},"reference":[{"issue":"157","key":"e_1_2_11_2_1","doi-asserted-by":"crossref","DOI":"10.1183\/16000617.0158-2019","article-title":"Prognosis of idiopathic pulmonary fibrosis without anti\u2010fibrotic therapy: a systematic review","volume":"29","author":"Khor YH","year":"2020","journal-title":"Eur Respir Rev"},{"issue":"6","key":"e_1_2_11_3_1","doi-asserted-by":"crossref","first-page":"699","DOI":"10.1164\/rccm.201101-0013OC","article-title":"Transglutaminase 2 and its role in pulmonary fibrosis","volume":"184","author":"Olsen KC","year":"2011","journal-title":"Am J Respir Crit Care Med"},{"issue":"5","key":"e_1_2_11_4_1","doi-asserted-by":"crossref","first-page":"594","DOI":"10.1165\/rcmb.2016-0379OC","article-title":"Extracellular matrix cross\u2010linking enhances fibroblast growth and protects against matrix proteolysis in 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