{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,31]],"date-time":"2026-10-31T15:00:09Z","timestamp":1793458809860,"version":"4.5.0"},"reference-count":26,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,11,10]],"date-time":"2025-11-10T00:00:00Z","timestamp":1762732800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pharmacol."],"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>JP-1366 (zastaprazan), a novel potassium-competitive acid blocker (P-CAB), was approved in South Korea in 2024 for treating erosive gastroesophageal reflux disease (GERD). This mass balance study characterized the pharmacokinetics, metabolism, excretion, and safety profile of JP-1366 in humans, supporting its further clinical development in China.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Six healthy Chinese male adults received a single oral dose of 20\u00a0mg (100\u00a0\u03bcCi) [\n                      <jats:sup>14<\/jats:sup>\n                      C]JP-1366 under fasting conditions in this open-label Phase I study. Serial samples of blood, plasma, urine, and feces were collected and analyzed to determine Pharmacokinetic parameters, total radioactive recovery, metabolic fate, and excretion routes.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      JP-1366 was rapidly absorbed, with median T\n                      <jats:sub>max<\/jats:sub>\n                      values of 0.875\u00a0h observed for both the parent drug and total radioactivity in human plasma. The mean plasma elimination half-life (t\n                      <jats:sub>1\/2<\/jats:sub>\n                      ) was approximately 28\u00a0h for JP-1366-related material. Furthermore, the blood-to-plasma ratio of total radioactivity ranged from 0.561 to 0.645, indicating limited distribution of drug-related material into blood cells. Within 264\u00a0h post-dose, 94.3% of the administered radioactive dose was recovered through excretion, predominantly via feces (51.9%) and urine (42.4%). JP-1366 underwent extensive metabolism\n                      <jats:italic>in vivo<\/jats:italic>\n                      , generating 57 metabolites, while the parent drug remained undetectable in excreted samples. The principal metabolic pathways involved oxidations (Phase I) and the following glucuronidation (Phase I\/II). JP-1366 exhibited a favorable safety profile, with no serious adverse events reported.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>JP-1366 exhibited favorable pharmacokinetic properties characterized by rapid absorption, extensive metabolism, and predominant fecal excretion of drug-related material. The principal metabolic pathways involved oxidations and the following glucuronidation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial Registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link>http:\/\/www.chinadrugtrials.org.cn\/<\/jats:ext-link>\n                      , identifier CTR20244931.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fphar.2025.1701581","type":"journal-article","created":{"date-parts":[[2025,11,10]],"date-time":"2025-11-10T14:28:03Z","timestamp":1762784883000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":5,"title":["Pharmacokinetics, mass balance, and metabolism of the novel potassium-competitive acid blocker JP-1366 in healthy Chinese adults following a single oral dose of [14C]JP-1366"],"prefix":"10.3389","volume":"16","author":[{"given":"Xuemei","family":"Liu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Decheng","family":"Deng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jian","family":"Meng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haitang","family":"Hu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Quankun","family":"Zhuang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xue","family":"Zhou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Long","family":"Fu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Binke","family":"Fan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xueting","family":"Xu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qin","family":"Huang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoyan","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fang","family":"Hou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2025,11,10]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"897","DOI":"10.1080\/17425255.2025.2505637","article-title":"Mass balance and metabolite profiles in humans of tegoprazan, a novel potassium-competitive acid blocker, using 14C-radiolabelled techniques","volume":"21","author":"Bian","year":"2025","journal-title":"Expert Opin. 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