{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T10:18:10Z","timestamp":1783333090769,"version":"3.54.6"},"reference-count":24,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2026,6,15]],"date-time":"2026-06-15T00:00:00Z","timestamp":1781481600000},"content-version":"vor","delay-in-days":14,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T00:00:00Z","timestamp":1780272000000},"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":[[2026,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Brigatinib is an ALK tyrosine kinase inhibitor approved for the treatment of adults with\n                    <jats:italic>ALK<\/jats:italic>\n                    + non\u2010small cell lung cancer. The commercial formulation of brigatinib is an immediate\u2010release (IR) tablet; however, an oral solution was developed for use in pediatric studies for patients unable to swallow solid oral dosage forms. This randomized, two\u2010period, two\u2010sequence crossover study assessed the relative bioavailability of the oral solution versus the IR tablet in healthy adults. Twelve participants received a single 90\u2010mg brigatinib dose as the oral solution or IR tablet on Day 1 of the first study period, followed by the alternate formulation on Day 1 of the second study period. Brigatinib pharmacokinetic parameters were similar following administration of the oral solution and IR tablet. The geometric least\u2010square mean ratios (oral solution vs IR tablet) for C\n                    <jats:sub>max<\/jats:sub>\n                    (0.92), AUC\n                    <jats:sub>last<\/jats:sub>\n                    (0.96), and AUC\n                    <jats:sub>inf<\/jats:sub>\n                    (0.96) were close to 1.00 with 90% confidence intervals within the bioequivalence range of 0.80\u20131.25 (C\n                    <jats:sub>max<\/jats:sub>\n                    , 0.87\u20130.98; AUC\n                    <jats:sub>last<\/jats:sub>\n                    , 0.88\u20131.04; AUC\n                    <jats:sub>inf<\/jats:sub>\n                    , 0.89\u20131.03). Treatment\u2010emergent adverse events were reported in three participants (25%), with the most frequent being cough (17%). These results indicate that the oral solution and IR tablet can be used interchangeably without dose adjustment in pediatric studies.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70075","type":"journal-article","created":{"date-parts":[[2026,6,15]],"date-time":"2026-06-15T13:12:01Z","timestamp":1781529121000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Phase 1 Study to Assess the Relative Bioavailability of Brigatinib Administered as an Oral Solution Versus an Immediate\u2010Release Tablet in Healthy Adults"],"prefix":"10.1002","volume":"15","author":[{"given":"Michael J.","family":"Hanley","sequence":"first","affiliation":[{"name":"Takeda Development Center Americas, Inc.  Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronald","family":"Gounden","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc.  Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bradley","family":"Hupf","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc.  Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saurabh","family":"Sarkar","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc.  Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert J.","family":"Fram","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc.  Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neeraj","family":"Gupta","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc.  Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,6,15]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-13-0318"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-08-0168"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/nature05945"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2016.71.5904"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1810171"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtho.2021.07.035"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-16-0569"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-023-01284-w"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(16)30392-8"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-017-0776-3"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.641"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.723"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/psp4.13106"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-020-00929-4"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10637-021-01095-5"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10637-023-01339-6"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.2198"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11864-023-01144-6"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjh.20154"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2024.42.16_suppl.10017"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2024-200077"},{"key":"e_1_2_10_23_1","unstructured":"Guidance for industry: bioavailability and bioequivalence studies submitted in NDAs or INDs \u2010 general considerations.2014. Accessed June 14 2020.http:\/\/www.fda.gov\/downloads\/drugs\/guidancecomplianceregulatoryinformation\/guidances\/ucm389370.pdf"},{"key":"e_1_2_10_24_1","unstructured":"Committee for Medicinal Products for Human Use.Guideline on the investigation of bioequivalence.2010. Accessed October 21 2025.https:\/\/www.ema.europa.eu\/en\/documents\/scientific\u2010guideline\/guideline\u2010investigation\u2010bioequivalence\u2010rev1_en.pdf"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.3389\/fddev.2025.1553286"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70075","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.70075","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70075","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T09:54:50Z","timestamp":1783331690000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.70075"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6]]},"references-count":24,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2026,6]]}},"alternative-id":["10.1002\/cpdd.70075"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.70075","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6]]},"assertion":[{"value":"2026-04-01","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-05-27","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-06-15","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70075"}}