{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T20:48:12Z","timestamp":1777668492658,"version":"3.51.4"},"reference-count":23,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2022,2,19]],"date-time":"2022-02-19T00:00:00Z","timestamp":1645228800000},"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":[[2022,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Deucravacitinib is a novel, oral, selective inhibitor of the intracellular signaling kinase tyrosine kinase 2. This phase 1, randomized, partially double\u2010blind, 4\u2010period crossover study in healthy adults was conducted to determine whether deucravacitinib 12 mg (therapeutic dose) or 36 mg (supratherapeutic dose) had a clinically relevant effect on the corrected QT interval and other electrocardiographic (ECG) parameters. Subjects received 1 of 4 sequences of placebo, deucravacitinib 12 mg, deucravacitinib 36 mg, and moxifloxacin 400 mg (positive control) in a randomized crossover fashion. The placebo\u2010corrected change from baseline for the QT interval corrected for heart rate using the Fridericia method (QTcF), ECG parameters, and safety measures were evaluated. A clinically meaningful QTcF prolongation of &gt;10 milliseconds was not found for deucravacitinib at tested doses. Assay sensitivity was demonstrated by the observation of known QT effects of moxifloxacin in the study. Deucravacitinib had no clinically relevant effect on other parameters and was generally well tolerated. The majority of adverse events (AEs) were mild, and all AEs resolved by study's end. Three treatment\u2010related serious AEs of pharyngitis, cellulitis, and lymphadenopathy occurred in 1 subject following administration of deucravacitinib 12 mg, but resolved by end of study. This study demonstrated that a single oral dose of deucravacitinib 12 or 36 mg did not produce a clinically relevant effect on the corrected QT interval or other measured ECG parameters in healthy adults.<\/jats:p>","DOI":"10.1002\/cpdd.1056","type":"journal-article","created":{"date-parts":[[2022,2,19]],"date-time":"2022-02-19T08:13:47Z","timestamp":1645258427000},"page":"442-453","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Lack of Electrocardiographic Effects of Deucravacitinib in Healthy Subjects"],"prefix":"10.1002","volume":"11","author":[{"given":"Anjaneya","family":"Chimalakonda","sequence":"first","affiliation":[{"name":"Bristol Myers Squibb Princeton  New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shalabh","family":"Singhal","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb Princeton  New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Raymond","family":"Darbenzio","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb Princeton  New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Randy","family":"Dockens","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb Princeton  New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Marchisin","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb Princeton  New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Subhashis","family":"Banerjee","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb Princeton  New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ihab G.","family":"Girgis","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb Princeton  New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Throup","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb Princeton  New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bing","family":"He","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb Princeton  New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Urvi","family":"Aras","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb Princeton  New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bindu","family":"Murthy","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb Princeton  New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,2,19]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1126\/scitranslmed.aaw1736"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1074\/jbc.M114.619502"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.jmedchem.9b00444"},{"key":"e_1_2_8_5_1","doi-asserted-by":"crossref","unstructured":"ChimalakondaA ArasU YaoM et\u00a0al.Pharmacokinetics and ADME characteristics of a selective TYK2 inhibitor BMS\u2010986165 following oral administration in healthy subjects [poster PIII\u2010027].Presented at: the Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics; March 13\u201016 2019;Washington DC.","DOI":"10.1093\/ecco-jcc\/jjy222.762"},{"key":"e_1_2_8_6_1","first-page":"859","article-title":"A first\u2010in\u2010human, study of BMS\u2010986165, a selective, potent, allosteric small molecule inhibitor of tyrosine kinase 2 [abstract SAT0226","volume":"76","author":"Catlett I","year":"2017","journal-title":"Ann Rheum Dis"},{"key":"e_1_2_8_7_1","unstructured":"ChimalakondaA SinghalS DockensR et al. Deucravacitinib (BMS\u2010986165) an oral selective tyrosine kinase 2 inhibitor: overview of pharmacokinetics in healthy volunteers including ADME food and pH effects and drug\u2010drug interactions [poster P1420]. Presented at: the European Academy of Dermatology and Venereology Virtual Congress; October 29\u201031 2020."},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjy222.473"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjy222.762"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1806382"},{"key":"e_1_2_8_11_1","unstructured":"MeasePJ DeodharA van derHeijdeD et\u00a0al. Efficacy and safety of deucravacitinib (BMS\u2010986165) an oral selective tyrosine kinase 2 inhibitor in patients with active psoriatic arthritis: results from a phase 2 randomized double\u2010blind placebo\u2010controlled trial [poster L03]. 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