{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T20:05:40Z","timestamp":1792008340244,"version":"4.4.0"},"reference-count":26,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2021,3,12]],"date-time":"2021-03-12T00:00:00Z","timestamp":1615507200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["R01\u2010DK122280"],"award-info":[{"award-number":["R01\u2010DK122280"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100005570","name":"Takeda Pharmaceuticals North America","doi-asserted-by":"publisher","award":["TAK\u2010954\u20102003"],"award-info":[{"award-number":["TAK\u2010954\u20102003"]}],"id":[{"id":"10.13039\/100005570","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2021,5]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Gastroparesis is defined by delayed gastric emptying with associated symptoms in the absence of mechanical obstruction.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To evaluate pharmacokinetics and pharmacodynamics of felcisetrag, a highly selective 5\u2010HT<jats:sub>4<\/jats:sub> receptor agonist, on total gut transit in patients with documented delayed gastric emptying of solids.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Single\u2010centre, placebo\u2010controlled study of 36 participants receiving placebo, 0.1mg, 0.3mg or 1.0mg of felcisetrag I.V. infusion, daily, for 3 days. At baseline, each participant completed a 4h, <jats:sup>99m<\/jats:sup>Tc\u2010egg meal (300 kcal, 30% fat) gastric emptying test. Following infusion (Day 2), gastric, small bowel and colonic transit of solids were measured over 48h (same meal plus <jats:sup>111<\/jats:sup>In\u2010charcoal delivered in methacrylate\u2010coated capsule). Samples were collected for pharmacokinetics. The primary endpoint was gastric emptying T<jats:sub>1\/2<\/jats:sub>. Statistical analysis used baseline parameters as covariates (ANCOVA).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Patients (22 idiopathic, 14 diabetic gastroparesis) were randomised to felcisetrag (0.1\u00a0mg, n\u00a0=\u00a010; 0.3\u00a0mg, n\u00a0=\u00a09; 1.0\u00a0mg, n\u00a0=\u00a07) or placebo (n\u00a0=\u00a010). Compared to placebo, felcisetrag significantly accelerated gastric emptying <jats:italic>T<\/jats:italic><jats:sub>1\/2<\/jats:sub>, colonic filling at 6h, and 10% small bowel transit time (overall <jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.01; all three doses individually Bonferroni corrected <jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.05) for all three measurements. Ascending colon emptying (<jats:italic>T<\/jats:italic><jats:sub>1\/2<\/jats:sub>) was significantly accelerated (all doses), and colonic transit at 48\u00a0hours was accelerated with 0.1\u00a0mg and 0.3\u00a0mg felcisetrag compared to placebo. Pharmacokinetic results were dose proportional. Felcisetrag was well tolerated with no clinically significant findings from clinical laboratory, vital signs or ECG.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>I.V. felcisetrag significantly accelerated gastric, small bowel and colonic transit in patients with gastroparesis, and should be further evaluated for short\u2010term treatment of gastric and intestinal motility disorders.<\/jats:p><jats:p>ClinicalTrials.gov #NCT03281577<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.16304","type":"journal-article","created":{"date-parts":[[2023,9,1]],"date-time":"2023-09-01T14:40:21Z","timestamp":1693579221000},"page":"1010-1020","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":32,"title":["Randomised study: effects of the 5\u2010HT<sub>4<\/sub> receptor agonist felcisetrag vs placebo on gut\u00a0transit in patients with gastroparesis"],"prefix":"10.1111","volume":"53","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8548-9228","authenticated-orcid":false,"given":"Victor","family":"Chedid","sequence":"first","affiliation":[{"name":"Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER) Division of Gastroenterology and Hepatology Mayo Clinic Rochester MN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justin","family":"Brandler","sequence":"additional","affiliation":[{"name":"Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER) Division of Gastroenterology and Hepatology Mayo Clinic Rochester MN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kayla","family":"Arndt","sequence":"additional","affiliation":[{"name":"Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER) Division of Gastroenterology and Hepatology Mayo Clinic Rochester MN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Priya","family":"Vijayvargiya","sequence":"additional","affiliation":[{"name":"Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER) Division of Gastroenterology and Hepatology Mayo Clinic Rochester MN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiao Jing","family":"Wang","sequence":"additional","affiliation":[{"name":"Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER) Division of Gastroenterology and Hepatology Mayo Clinic Rochester MN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Duane","family":"Burton","sequence":"additional","affiliation":[{"name":"Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER) Division of Gastroenterology and Hepatology Mayo Clinic Rochester MN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W. 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