{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,27]],"date-time":"2025-05-27T11:07:02Z","timestamp":1748344022873,"version":"3.37.3"},"reference-count":22,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2024,3,30]],"date-time":"2024-03-30T00:00:00Z","timestamp":1711756800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2024,3,30]],"date-time":"2024-03-30T00:00:00Z","timestamp":1711756800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer Inc.","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Eur J Drug Metab Pharmacokinet"],"published-print":{"date-parts":[[2024,5]]},"DOI":"10.1007\/s13318-024-00893-5","type":"journal-article","created":{"date-parts":[[2024,3,30]],"date-time":"2024-03-30T16:02:01Z","timestamp":1711814521000},"page":"367-381","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Assessment of the Effects of Abrocitinib on the Pharmacokinetics of Probe Substrates of Cytochrome P450 1A2, 2B6 and 2C19 Enzymes and Hormonal Oral Contraceptives in Healthy Individuals"],"prefix":"10.1007","volume":"49","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6961-8667","authenticated-orcid":false,"given":"Xiaoxing","family":"Wang","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin E.","family":"Dowty","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sakambari","family":"Tripathy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vu H.","family":"Le","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yeamin","family":"Huh","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Madelyn","family":"Curto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jennifer A.","family":"Winton","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Melissa T.","family":"O\u2019Gorman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gary","family":"Chan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bimal K.","family":"Malhotra","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,3,30]]},"reference":[{"key":"893_CR1","doi-asserted-by":"publisher","first-page":"1130","DOI":"10.1021\/acs.jmedchem.7b01598","volume":"61","author":"ML Vazquez","year":"2018","unstructured":"Vazquez ML, Kaila N, Strohbach JW, Trzupek JD, Brown MF, Flanagan ME, et al. Identification of N-{cis-3-[Methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino]cyclobutyl}propane-1-sulfo namide (PF-04965842): a selective JAK1 clinical candidate for the treatment of autoimmune diseases. J Med Chem. 2018;61:1130\u201352. https:\/\/doi.org\/10.1021\/acs.jmedchem.7b01598.","journal-title":"J Med Chem"},{"key":"893_CR2","doi-asserted-by":"publisher","first-page":"255","DOI":"10.1016\/s0140-6736(20)30732-7","volume":"396","author":"EL Simpson","year":"2020","unstructured":"Simpson EL, Sinclair R, Forman S, Wollenberg A, Aschoff R, Cork M, et al. Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet. 2020;396:255\u201366. https:\/\/doi.org\/10.1016\/s0140-6736(20)30732-7.","journal-title":"Lancet"},{"key":"893_CR3","doi-asserted-by":"publisher","first-page":"863","DOI":"10.1001\/jamadermatol.2020.1406","volume":"156","author":"JI Silverberg","year":"2020","unstructured":"Silverberg JI, Simpson EL, Thyssen JP, Gooderham M, Chan G, Feeney C, et al. Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis: a randomized clinical trial. JAMA Dermatol. 2020;156:863\u201373. https:\/\/doi.org\/10.1001\/jamadermatol.2020.1406.","journal-title":"JAMA Dermatol"},{"key":"893_CR4","doi-asserted-by":"publisher","first-page":"1371","DOI":"10.1001\/jamadermatol.2019.2855","volume":"155","author":"MJ Gooderham","year":"2019","unstructured":"Gooderham MJ, Forman SB, Bissonnette R, Beebe JS, Zhang W, Banfield C, et al. Efficacy and safety of oral janus kinase 1 inhibitor abrocitinib for patients with atopic dermatitis: a phase 2 randomized clinical trial. JAMA Dermatol. 2019;155:1371\u20139. https:\/\/doi.org\/10.1001\/jamadermatol.2019.2855.","journal-title":"JAMA Dermatol"},{"key":"893_CR5","doi-asserted-by":"publisher","first-page":"1101","DOI":"10.1056\/NEJMoa2019380","volume":"384","author":"T Bieber","year":"2021","unstructured":"Bieber T, Simpson EL, Silverberg JI, Thaci D, Paul C, Pink AE, et al. Abrocitinib versus placebo or dupilumab for atopic dermatitis. N Engl J Med. 2021;384:1101\u201312. https:\/\/doi.org\/10.1056\/NEJMoa2019380.","journal-title":"N Engl J Med."},{"key":"893_CR6","doi-asserted-by":"publisher","first-page":"2335","DOI":"10.1080\/09546634.2021.1961997","volume":"33","author":"K Reich","year":"2022","unstructured":"Reich K, Thyssen JP, Blauvelt A, Eyerich K, Soong W, Rice KP, et al. Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: a randomised, double-blind, multicentre phase 3 trial. Lancet. 2022;33:2335\u201343. https:\/\/doi.org\/10.1080\/09546634.2021.1961997.","journal-title":"Lancet"},{"key":"893_CR7","doi-asserted-by":"publisher","first-page":"1311","DOI":"10.1002\/jcph.1858","volume":"61","author":"EQ Wang","year":"2021","unstructured":"Wang EQ, Le V, O\u2019Gorman M, Tripathy S, Dowty ME, Wang L, et al. Effects of hepatic impairment on the pharmacokinetics of abrocitinib and its metabolites. J Clin Pharmacol. 2021;61:1311\u201323. https:\/\/doi.org\/10.1002\/jcph.1858.","journal-title":"J Clin Pharmacol"},{"key":"893_CR8","doi-asserted-by":"publisher","first-page":"419","DOI":"10.1007\/s13318-021-00745-6","volume":"47","author":"X Wang","year":"2022","unstructured":"Wang X, Dowty ME, Wouters A, Tatulych S, Connell CA, Le VH, et al. Assessment of the effects of inhibition or induction of CYP2C19 and CYP2C9 enzymes, or inhibition of OAT3, on the pharmacokinetics of abrocitinib and its metabolites in healthy individuals. Eur J Drug Metab Pharmacokinet. 2022;47:419\u201329. https:\/\/doi.org\/10.1007\/s13318-021-00745-6.","journal-title":"Eur J Drug Metab Pharmacokinet"},{"issue":"3","key":"893_CR9","doi-asserted-by":"publisher","first-page":"629","DOI":"10.1208\/s12248-013-9470-x","volume":"15","author":"T Prueksaritanont","year":"2013","unstructured":"Prueksaritanont T, Chu X, Gibson C, Cui D, Yee KL, Ballard J, et al. Drug-drug interaction studies: regulatory guidance and an industry perspective. AAPS J. 2013;15(3):629\u201345. https:\/\/doi.org\/10.1208\/s12248-013-9470-x.","journal-title":"AAPS J"},{"key":"893_CR10","unstructured":"Clinical drug interaction studies\u2014cytochrome P450 enzyme- and transporter-mediated drug interactions guidance for industry. FDA Guidance Document January 2020, https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/clinical-drug-interaction-studies-cytochrome-p450-enzyme-and-transporter-mediated-drug-interactions. Accessed Dec 2023."},{"issue":"3","key":"893_CR11","doi-asserted-by":"publisher","first-page":"271","DOI":"10.1007\/s40262-013-0115-0","volume":"53","author":"M Donzelli","year":"2014","unstructured":"Donzelli M, Derungs A, Serratore MG, et al. The basel cocktail for simultaneous phenotyping of human cytochrome P450 isoforms in plasma, saliva and dried blood spots. Clin Pharmacokinet. 2014;53(3):271\u201382. https:\/\/doi.org\/10.1007\/s40262-013-0115-0.","journal-title":"Clin Pharmacokinet"},{"issue":"2","key":"893_CR12","doi-asserted-by":"publisher","first-page":"133","DOI":"10.2165\/00003088-200746020-00003","volume":"46","author":"H Zhang","year":"2007","unstructured":"Zhang H, Cui D, Wang B, Han YH, Balimane P, Yang Z, et al. Pharmacokinetic drug interactions involving 17alpha-ethinylestradiol: a new look at an old drug. Clin Pharmacokinet. 2007;46(2):133\u201357. https:\/\/doi.org\/10.2165\/00003088-200746020-00003.","journal-title":"Clin Pharmacokinet"},{"key":"893_CR13","doi-asserted-by":"publisher","DOI":"10.1155\/2014\/102184","volume":"2014","author":"S Lello","year":"2014","unstructured":"Lello S, Cavani A. Ethynilestradiol 20 mcg plus levonorgestrel 100 mcg: clinical pharmacology. Int J Endocrinol. 2014;2014: 102184. https:\/\/doi.org\/10.1155\/2014\/102184.","journal-title":"Int J Endocrinol."},{"issue":"3","key":"893_CR14","doi-asserted-by":"publisher","first-page":"381","DOI":"10.1517\/17425255.2.3.381","volume":"2","author":"M Iyer","year":"2006","unstructured":"Iyer M, Reschly EJ, Krasowski MD. Functional evolution of the pregnane X receptor. Expert Opin Drug Metab Toxicol. 2006;2(3):381\u201397. https:\/\/doi.org\/10.1517\/17425255.2.3.381.","journal-title":"Expert Opin Drug Metab Toxicol."},{"key":"893_CR15","doi-asserted-by":"publisher","first-page":"166","DOI":"10.1124\/dmd.105.006874","volume":"34","author":"A Galetin","year":"2006","unstructured":"Galetin A, Burt H, Gibbons L, Houston JB. Prediction of time-dependent CYP3A4 drug\u2013drug interactions: impact of enzyme degradation, parallel elimination pathways, and intestinal inhibition. Drug Metab Dispos. 2006;34:166\u201375. https:\/\/doi.org\/10.1124\/dmd.105.006874.","journal-title":"Drug Metab Dispos"},{"issue":"6","key":"893_CR16","doi-asserted-by":"publisher","first-page":"1345","DOI":"10.1002\/cpt.1435","volume":"105","author":"A Tornio","year":"2019","unstructured":"Tornio A, Filppula AM, Niemi M, Backman JT. Clinical studies on drug-drug interactions involving metabolism and transport: methodology, pitfalls, and interpretation. Clin Pharmacol Ther. 2019;105(6):1345\u201361. https:\/\/doi.org\/10.1002\/cpt.1435.","journal-title":"Clin Pharmacol Ther"},{"key":"893_CR17","doi-asserted-by":"publisher","first-page":"1223","DOI":"10.1007\/s00280-013-2287-6","volume":"72","author":"C Dutreix","year":"2013","unstructured":"Dutreix C, Munarini F, Lorenzo S, et al. Investigation into CYP3A4-mediated drug\u2013drug interactions on midostaurin in healthy volunteers. Cancer Chemother Pharmacol. 2013;72:1223\u201334. https:\/\/doi.org\/10.1007\/s00280-013-2287-6.","journal-title":"Cancer Chemother Pharmacol"},{"key":"893_CR18","unstructured":"Omeprazole SmPC, https:\/\/www.ema.europa.eu\/en\/documents\/referral\/losec-article-30-referrals-annex-iii_en.pdf. Accessed May 2022."},{"key":"893_CR19","doi-asserted-by":"publisher","first-page":"S80","DOI":"10.1016\/j.dmpk.2020.04.191","volume":"35","author":"M Dowty","year":"2020","unstructured":"Dowty M, Yang X, Lin J, Bauman J, Doran A, Goosen T, et al. P190 - The effect of CYP2C9 and CYP2C19 genotype on the pharmacokinetics of PF-04965842, A JAK1 inhibitor in clinical development. Drug Metab Pharmacokinet. 2020;35:S80. https:\/\/doi.org\/10.1016\/j.dmpk.2020.04.191.","journal-title":"Drug Metab Pharmacokinet"},{"key":"893_CR20","doi-asserted-by":"publisher","first-page":"1776","DOI":"10.1111\/bcp.13612","volume":"84","author":"E Peeva","year":"2018","unstructured":"Peeva E, Hodge MR, Kieras E, Vazquez ML, Goteti K, Tarabar SG, et al. Evaluation of a Janus kinase 1 inhibitor, PF-04965842, in healthy subjects: a phase 1, randomized, placebo-controlled, dose-escalation study. Br J Clin Pharmacol. 2018;84:1776\u201388. https:\/\/doi.org\/10.1111\/bcp.13612.","journal-title":"Br J Clin Pharmacol"},{"issue":"1","key":"893_CR21","doi-asserted-by":"publisher","first-page":"79","DOI":"10.1007\/s40262-015-0294-y","volume":"55","author":"A Derungs","year":"2016","unstructured":"Derungs A, Donzelli M, Berger B, Noppen C, Kr\u00e4henb\u00fchl S, Haschke M. Effects of cytochrome P450 inhibition and induction on the phenotyping metrics of the basel cocktail: a randomized crossover study. Clin Pharmacokinet. 2016;55(1):79\u201391. https:\/\/doi.org\/10.1007\/s40262-015-0294-y.","journal-title":"Clin Pharmacokinet"},{"issue":"2","key":"893_CR22","doi-asserted-by":"publisher","first-page":"83","DOI":"10.1016\/j.xfre.2020.06.006","volume":"1","author":"ML Kavanaugh","year":"2020","unstructured":"Kavanaugh ML, Pliskin E. Use of contraception among reproductive-aged women in the United States, 2014 and 2016. F&S Reports. 2020;1(2):83\u201393. https:\/\/doi.org\/10.1016\/j.xfre.2020.06.006.","journal-title":"F&S Reports"}],"container-title":["European Journal of Drug Metabolism and Pharmacokinetics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s13318-024-00893-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s13318-024-00893-5\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s13318-024-00893-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,4,27]],"date-time":"2024-04-27T02:10:27Z","timestamp":1714183827000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s13318-024-00893-5"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,3,30]]},"references-count":22,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2024,5]]}},"alternative-id":["893"],"URL":"https:\/\/doi.org\/10.1007\/s13318-024-00893-5","relation":{},"ISSN":["0378-7966","2107-0180"],"issn-type":[{"type":"print","value":"0378-7966"},{"type":"electronic","value":"2107-0180"}],"subject":[],"published":{"date-parts":[[2024,3,30]]},"assertion":[{"value":"13 March 2024","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"30 March 2024","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All authors are employees and stockholders of Pfizer Inc.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This research was conducted in accordance with the Helsinki Declaration of 1964 and its later amendments. The final protocol, any amendments and informed consent documentation were reviewed and approved by the Independent Ethics Committee (Comite d'Ethique Hospitalo-Facultaire Erasme-ULB, Brussels, Belgium, for the midazolam DDI study in 2018; IntegReview Ethical Review Board, Austin, TX, USA, for the OC DDI study in 2018; Advarra, Columbia, MD, USA, for the cocktail DDI study in 2021) at the investigational center participating in the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Written informed consent was obtained from all participants prior to enrollment.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by XW, BM, MD, VHL, YH, MC, MO\u2019G, JAW and GC. Bioanalytical data preparation and interpretation were performed by ST. VL: performed all statistical analyses of pharmacokinetic data. MC and GC: contributed to study safety. The first draft of the manuscript was written by XW; all authors critically reviewed the drafts and approved the final manuscript.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}