{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,25]],"date-time":"2026-07-25T05:03:08Z","timestamp":1784955788369,"version":"3.55.0"},"reference-count":27,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T00:00:00Z","timestamp":1784851200000},"content-version":"vor","delay-in-days":23,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"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":[[2026,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Paltusotine is a novel, nonpeptide, once\u2010daily oral, selective somatostatin 2 receptor (SST2) agonist. We evaluated the pharmacokinetics, pharmacodynamics, and safety of oral paltusotine in healthy Japanese adults in single\u2011dose (20, 40, 60, 80\u00a0mg) and repeated\u2011dose (40\u00a0mg once daily for 7 days in a two\u2010sequence, two\u2011period crossover design) studies. In addition, the effects of food intake and pharmacodynamics were examined in the repeated\u2010dose study. Eight participants were enrolled in each dose of the single\u2010dose study, and 12 participants were enrolled in the repeated\u2010dose study. In both studies, there were no deaths, serious adverse events, or severe adverse events. In the single\u2010dose study, plasma paltusotine exposures increased in a dose\u2010dependent manner for the dose range of 20 to 80\u00a0mg (based on C\n                    <jats:sub>max<\/jats:sub>\n                    and AUC\n                    <jats:sub>0\u2010\u221e<\/jats:sub>\n                    ), and the elimination half\u2010life (t\n                    <jats:sub>1\/2<\/jats:sub>\n                    ) was 24\u201028 h. In the repeated\u2010dose study, similar reductions from baseline in serum insulin\u2010like growth factor\u20101 (IGF\u2010I) were observed for 1\u2010h pre\u2010prandial (\u221260.1 \u00b1 26.0\u00a0ng\/mL) and 3\u2010h post\u2010prandial administration (\u221261.6 \u00b1 17.7\u00a0ng\/mL) on Day 7. Overall, this study establishes the pharmacokinetics, pharmacodynamics, and safety in healthy Japanese adults to support the development of paltusotine as a treatment for acromegaly and pituitary gigantism.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70085","type":"journal-article","created":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T12:36:24Z","timestamp":1784896584000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Phase 1 Study of Paltusotine, a Novel Oral Once\u2011Daily, Nonpeptide Selective Somatostatin Receptor 2 Agonist, in Healthy Japanese Adults"],"prefix":"10.1002","volume":"15","author":[{"given":"Fumio","family":"Otsuka","sequence":"first","affiliation":[{"name":"Department of General Medicine Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keiko","family":"Hanabara","sequence":"additional","affiliation":[{"name":"Medical Affairs Group Medical Affairs Department Sanwa Kagaku Kenkyusho Co., Ltd.  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seigo","family":"Akari","sequence":"additional","affiliation":[{"name":"Medical Affairs Group Medical Affairs Department Sanwa Kagaku Kenkyusho Co., Ltd.  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katsunori","family":"Kitamoto","sequence":"additional","affiliation":[{"name":"Project Management Group Project Management Department Sanwa Kagaku Kenkyusho Co., Ltd.  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yosuke","family":"Inagaki","sequence":"additional","affiliation":[{"name":"Clinical Development Department Sanwa Kagaku Kenkyusho Co., Ltd.  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dylan","family":"Glatt","sequence":"additional","affiliation":[{"name":"Crinetics Pharmaceuticals, Inc.  San Diego USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harumi","family":"Murakami","sequence":"additional","affiliation":[{"name":"Souseikai Sumida Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naoki","family":"Uchida","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology Department of Pharmacology Showa Medical University School of Medicine  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,24]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/B978-0-323-29738-7.00009-5"},{"key":"e_1_2_11_3_1","volume-title":"Endotext","author":"Carroll PV"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1530\/EJE-08-0267"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11102-020-01063-x"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11154-020-09588-z"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41574-018-0058-5"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2013-3757"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2265.2007.02878.x"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11102-015-0677-y"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/ejendo\/lvaf200"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12902-020-00595-4"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1136\/jim-2017-000570"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1530\/EJE-15-1042"},{"key":"e_1_2_11_15_1","unstructured":"Crinetics Pharmaceuticals Inc.PALSONIFY (paltusotine) tablets: US prescribing information.2025."},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/bcp.70020"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11102-021-01201-z"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1210\/clinem\/dgac643"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1210\/clinem\/dgae385"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1210\/clinem\/dgaf579"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.2133\/dmpk.DMPK-11-RV-111"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1210\/jendso\/bvab048.1068"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.12698"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.1994.tb04344.x"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12020-016-0895-8"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.1021\/acsmedchemlett.2c00431"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-020-01561-1"},{"key":"e_1_2_11_28_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11102-017-0797-7"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70085","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.70085","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70085","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,25]],"date-time":"2026-07-25T04:41:42Z","timestamp":1784954502000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.70085"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7]]},"references-count":27,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2026,7]]}},"alternative-id":["10.1002\/cpdd.70085"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.70085","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7]]},"assertion":[{"value":"2026-05-14","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-07-08","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-07-24","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70085"}}