{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T04:12:58Z","timestamp":1791519178601,"version":"4.3.4"},"reference-count":17,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2026,4,24]],"date-time":"2026-04-24T00:00:00Z","timestamp":1776988800000},"content-version":"vor","delay-in-days":23,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T00:00:00Z","timestamp":1775001600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>This study aimed to evaluate the pharmacokinetics, pharmacodynamics, and safety of a single dose of luseogliflozin (TS\u2010071), a sodium\u2013glucose cotransporter 2 (SGLT2) inhibitor, in Japanese children and adolescents with type 2 diabetes, with the goal of informing dose selection for future research. In this multicenter, open\u2010label, parallel\u2010group Phase 1 trial, patients aged 9\u201017 years received a single oral dose of luseogliflozin at 1.25, 2.5, or 5\u00a0mg. Pharmacokinetic and pharmacodynamic parameters were assessed and compared with existing adult data. In total, 19 patients completed the study. The mean age was 14.3 \u00b1 1.9 years, and the mean body weight was 77.28 \u00b1 25.32\u00a0kg. Plasma luseogliflozin concentrations increased in a dose\u2010dependent manner. The maximum plasma concentration and the area under the curve were comparable to those observed in adults. Administration of luseogliflozin at all dose levels resulted in a substantial increase in urinary glucose excretion. No safety concerns emerged from the single\u2010dose administration. Luseogliflozin demonstrated favorable pharmacokinetic, pharmacodynamic, and safety profiles in pediatric patients, consistent with adult findings. These results support the selection of 2.5\u2010 and 5\u2010mg doses for a future Phase 3 pediatric study.<\/jats:p>","DOI":"10.1002\/cpdd.70065","type":"journal-article","created":{"date-parts":[[2026,4,24]],"date-time":"2026-04-24T13:52:58Z","timestamp":1777038778000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Pharmacokinetics, Pharmacodynamics, and Safety of Single\u2010Dose Luseogliflozin (TS\u2010071) in Japanese Children and Adolescents With Type 2 Diabetes: A Multicenter, Open\u2010Label, Parallel\u2010Group Phase 1 Study"],"prefix":"10.1002","volume":"15","author":[{"given":"Toru","family":"Kikuchi","sequence":"first","affiliation":[{"name":"Department of Pediatrics Saitama Medical University Hospital  Saitama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hidefumi","family":"Nakamura","sequence":"additional","affiliation":[{"name":"Department of Research and Development Supervision National Center for Child Health and Development  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hideo","family":"Umeuchi","sequence":"additional","affiliation":[{"name":"Development Headquarters Taisho Pharmaceutical Co. Ltd  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iwao","family":"Kitajima","sequence":"additional","affiliation":[{"name":"Development Headquarters Taisho Pharmaceutical Co. Ltd  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatsuhiko","family":"Urakami","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Nihon University Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,4,24]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2022.109785"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1159\/000543033"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc13-0954"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2017.0686"},{"issue":"6","key":"e_1_2_10_6_1","first-page":"546","article-title":"International society for pediatric and adolescent diabetes clinical practice consensus guidelines 2024: glycemic targets","volume":"97","author":"Bock M","year":"2024","journal-title":"Horm Res Paediatr"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc24-S014"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1155\/2024\/6295345"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1185\/03007995.2014.912983"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12647"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/dme.13629"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/pedi.12626"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-015-0200-x"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1080\/00498254.2016.1193263"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-014-0140-7"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12647"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrendo.2011.243"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc13-0387"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70065","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.70065","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70065","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,25]],"date-time":"2026-04-25T03:09:07Z","timestamp":1777086547000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.70065"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4]]},"references-count":17,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2026,4]]}},"alternative-id":["10.1002\/cpdd.70065"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.70065","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4]]},"assertion":[{"value":"2025-11-27","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-04-15","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-04-24","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70065"}}