{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T08:09:16Z","timestamp":1778659756380,"version":"3.51.4"},"reference-count":18,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2024,2,12]],"date-time":"2024-02-12T00:00:00Z","timestamp":1707696000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2024,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Belumosudil is a selective rho\u2010associated coiled\u2010coil\u2010containing protein kinase 2 inhibitor in clinical use for the treatment of chronic graft\u2010versus\u2010host disease. The current tablet formulation may be inappropriate for children or adults with dysphagia and\/or upper gastrointestinal manifestations of chronic graft\u2010versus\u2010host disease. This study (NCT04735822) assessed the taste and palatability of oral suspensions of belumosudil, evaluated the relative bioavailability of an oral suspension versus the tablet formulation, and characterized the effect of food on the pharmacokinetics of an oral suspension. Addition of sweetener and\/or flavor vehicle improved the taste. Relative bioavailability of 200\u2010mg doses of the oral suspension and tablet in the fed state was similar for belumosudil and its metabolites (KD025m1 and KD025m2), but absorption was faster with the oral suspension (median time to maximum concentration: 2 vs 3 hours). Administration of the oral suspension with food increased exposure compared with fasted administration, with maximum observed concentration being increased by 16% and area under the concentration\u2010time curve from time 0 to the last measurable concentration (AUC<jats:sub>0\u2010last<\/jats:sub>) by 19%. Safety and tolerability were consistent with the known safety profile of belumosudil. These results may support administration of a 200\u2010mg belumosudil oral suspension with or without food.<\/jats:p>","DOI":"10.1002\/cpdd.1378","type":"journal-article","created":{"date-parts":[[2024,2,12]],"date-time":"2024-02-12T15:04:48Z","timestamp":1707750288000},"page":"491-498","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Two\u2010Part Phase 1 Study to Evaluate the Taste Profile of Novel Belumosudil Oral Suspensions and Assess the Relative Bioavailability and Food Effect of the Selected Belumosudil Oral Suspension Compared With Oral Tablet Reference in Healthy Male Participants"],"prefix":"10.1002","volume":"13","author":[{"given":"Olivier","family":"Schueller","sequence":"first","affiliation":[{"name":"Kadmon, A Sanofi Company  Cambridge MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Galit","family":"Regev","sequence":"additional","affiliation":[{"name":"Kadmon, A Sanofi Company  Cambridge MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nand","family":"Singh","sequence":"additional","affiliation":[{"name":"Quotient Sciences  Nottingham UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ashley","family":"Willson","sequence":"additional","affiliation":[{"name":"Quotient Sciences  Nottingham UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Beville","sequence":"additional","affiliation":[{"name":"Quotient Sciences  Nottingham UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nazim","family":"Kanji","sequence":"additional","affiliation":[{"name":"Quotient Sciences  Nottingham UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lauren","family":"Lohmer","sequence":"additional","affiliation":[{"name":"Nuventra, Inc.  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