{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T14:38:40Z","timestamp":1786977520111,"version":"build-2736575974"},"reference-count":27,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2025,4,30]],"date-time":"2025-04-30T00:00:00Z","timestamp":1745971200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2025,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    RBN\u20103143 is an inhibitor of PARP14 in development for inflammatory diseases. Multiple assessments were conducted to evaluate the clinical pharmacology properties of RBN\u20103134. A randomized, double\u2010blind, placebo\u2010controlled study assigned healthy volunteers (HVs) to single ascending doses (SADs) (25\u20101000\u00a0mg) or multiple ascending doses (MADs) (150, 300, and 500\u00a0mg twice daily [BID] for 14 days) of RBN\u20103143 or placebo. An open\u2010label, randomized, 3\u2010period, cross\u2010over study evaluated the effects of food and pantoprazole (40\u00a0mg once daily [QD]) on the pharmacokinetics of RBN\u20103143 (500\u00a0mg), and a pharmacokinetic drug\u2013drug interaction study with oral midazolam (2\u00a0mg) determined whether RBN\u20103143 (300\u00a0mg BID for 14 days) is an inducer of cytochrome P4503A4 (CYP3A4). The most common treatment\u2010related treatment\u2010emergent adverse events in subjects taking RBN\u20103143 were headache, nausea, vomiting, and elevated serum creatinine. In the SAD, RBN\u20103143 C\n                    <jats:sub>max<\/jats:sub>\n                    and AUC\n                    <jats:sub>inf<\/jats:sub>\n                    increased with dose, and T\n                    <jats:sub>max<\/jats:sub>\n                    was 2\u00a0hours. RBN\u20103143 was cleared from plasma with an apparent terminal half\u2010life ranging from 3 to 11\u00a0hours. In the MAD, C\n                    <jats:sub>max<\/jats:sub>\n                    and AUC\n                    <jats:sub>inf<\/jats:sub>\n                    increased 1.5\u2010 and 1.6\u2010fold, respectively, following 14 days of 150, 300, and 500\u00a0mg BID dosing. Dosing of RBN\u20103143 with food resulted in higher C\n                    <jats:sub>max<\/jats:sub>\n                    and AUC\n                    <jats:sub>inf<\/jats:sub>\n                    ratios of 1.74 and 1.42, respectively. Coadministration with pantoprazole did not impact RBN\u20103143 exposure. RBN\u20103143 was an inducer of CYP3A4 in most but not all subjects, with mean midazolam C\n                    <jats:sub>max<\/jats:sub>\n                    and AUC\n                    <jats:sub>inf<\/jats:sub>\n                    ratios of 0.92 and 0.88, respectively. The clinical pharmacology properties of RBN\u20103143 in HVs support further development for inflammatory diseases.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.1539","type":"journal-article","created":{"date-parts":[[2025,4,30]],"date-time":"2025-04-30T22:50:37Z","timestamp":1746053437000},"page":"493-504","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["First\u2010in\u2010Human Phase 1 Study to Evaluate the Clinical Pharmacology Properties of RBN\u20103143, a Novel Inhibitor of Mono\u2010Adenosine Diphosphate Ribosyltransferase\u2010PARP14"],"prefix":"10.1002","volume":"14","author":[{"given":"Thomas M.","family":"Polasek","sequence":"first","affiliation":[{"name":"CMAX Clinical Research Pty Ltd  Adelaide South Australia Australia"},{"name":"Centre for Medicines Use and Safety Monash University  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra","family":"Cole","sequence":"additional","affiliation":[{"name":"New Zealand Clinical Research  Auckland New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Viviana","family":"Boz\u00f3n","sequence":"additional","affiliation":[{"name":"Ribon Therapeutics Inc.  Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erika","family":"Manyak","sequence":"additional","affiliation":[{"name":"Ribon Therapeutics Inc.  Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Novak","sequence":"additional","affiliation":[{"name":"Ribon Therapeutics Inc.  Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara","family":"Yang","sequence":"additional","affiliation":[{"name":"Ribon Therapeutics Inc.  Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Briohny A.","family":"Johnston","sequence":"additional","affiliation":[{"name":"CMAX Clinical Research Pty Ltd  Adelaide South Australia Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sudha","family":"Parasuraman","sequence":"additional","affiliation":[{"name":"Ribon Therapeutics Inc.  Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kushal J.","family":"Paneliya","sequence":"additional","affiliation":[{"name":"CMAX Clinical Research Pty Ltd  Adelaide South Australia Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Virna","family":"Schuck","sequence":"additional","affiliation":[{"name":"Ribon Therapeutics Inc.  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