{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T00:58:03Z","timestamp":1747184283318,"version":"3.40.5"},"reference-count":16,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2020,9,10]],"date-time":"2020-09-10T00:00:00Z","timestamp":1599696000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2021,1]]},"abstract":"<jats:p>Cenerimod is a sphingosine\u20101\u2010phosphate 1 receptor (S1P<jats:sub>1<\/jats:sub>R) modulator in phase II development for treatment of systemic lupus erythematosus. Its pharmacokinetics (PKs), pharmacodynamics (PDs), as well as safety and tolerability were investigated in white and Asian subjects to allow for recruitment of Asian patients in future studies. A randomized, double\u2010blind, placebo\u2010controlled parallel\u2010group study was performed in 20 healthy male subjects (<jats:italic>n<\/jats:italic>\u00a0=\u00a010 per ethnicity). A single, oral dose of 4\u00a0mg cenerimod or placebo (ratio 8:2) was administered under fasted conditions. The PKs of cenerimod were similar in white and Asian subjects indicated by geometric mean ratios (90% confidence interval) of 0.99 (0.80\u20131.21) for maximum plasma concentration, 0.96 (0.75\u20131.24) for area under the plasma concentration\u2010time curve from 0 to infinity, and 1.04 (0.86\u20131.25) for terminal half\u2010life. Accordingly, the extent and time course of reduction in lymphocyte count (as PD biomarker) were also similar in white and Asian subjects as compared with placebo. As observed for other S1PR modulators, a transient mean (SD) heart rate reduction in white (15.1 (14.8) bpm) and Asian (11.8 (6.16) bpm) subjects was observed following administration of cenerimod. The drug was safe and well\u2010tolerated indicated by occurrence of a single adverse event of chemical conjunctivitis in a white subject that was not suspected as study drug related. In conclusion, the determined absence of any relevant PK or PD differences supports using the same doses of cenerimod in white and Asian patients in upcoming late\u2010phase studies.<\/jats:p>","DOI":"10.1111\/cts.12873","type":"journal-article","created":{"date-parts":[[2020,8,29]],"date-time":"2020-08-29T17:19:35Z","timestamp":1598721575000},"page":"143-147","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Pharmacokinetics and Pharmacodynamics of Cenerimod, A Selective S1P<sub>1<\/sub>R Modulator, Are Not Affected by Ethnicity in Healthy Asian and White Subjects"],"prefix":"10.1111","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4899-8768","authenticated-orcid":false,"given":"Pierre\u2010Eric","family":"Juif","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacology Idorsia Pharmaceuticals Ltd  Allschwil Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jasper","family":"Dingemanse","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology Idorsia Pharmaceuticals Ltd  Allschwil Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Winkle","sequence":"additional","affiliation":[{"name":"Anaheim Clinical Trials, LLC  Anaheim California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mike","family":"Ufer","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology Idorsia Pharmaceuticals Ltd  Allschwil Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,9,10]]},"reference":[{"key":"e_1_2_10_1_1","doi-asserted-by":"publisher","DOI":"10.1084\/jem.20091343"},{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/lupus-2019-000354"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms18122636"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms20133232"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1080\/17425255.2016.1196188"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1080\/00498254.2020.1736688"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.14182"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.877"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/prp2.370"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1201\/b14095"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.5414\/CPP45098"},{"key":"e_1_2_10_12_1","unstructured":"Novartis.Mayzent Prescribing Information.https:\/\/www.mayzent.com\/index.jsp?utm_source=bing&utm_medium=paid&utm_campaign=Mayzent.com_Brand_Bing_7.2020;S;PH;BR;NER;DTC;BR&utm_term=Brand_Phrase%20%7c%20mayzent&&msclkid=c04f35d2a1211c2f7a056a92a8d5917f&gclid=c04f35d2a1211c2f7a056a92a8d5917f&gclsrc=3p.ds. 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