{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T19:39:01Z","timestamp":1792093141921,"version":"4.4.0"},"reference-count":28,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2021,5,3]],"date-time":"2021-05-03T00:00:00Z","timestamp":1620000000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2021,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Cortexolone 17\u03b1\u2010propionate, also known as clascoterone, is a potent androgen receptor inhibitor intended for the topical treatment of skin diseases associated with androgenic pathway alterations. In nonclinical studies, cortexolone 17\u03b1\u2010propionate was found to have a weak inhibitory effect on human Ether\u2010\u00e0\u2010go\u2010go\u2010Related Gene (hERG) potassium channels, which are vital for normal electrical activity in the heart. When used in a cream formulation, little cortexolone 17\u03b1\u2010propionate is absorbed. However, the solution formulation developed for the treatment of androgenetic alopecia leads to a measurable systemic concentration and accumulation of the antiandrogen. This phase 1 study assessed the effect of cortexolone 17\u03b1\u2010propionate on the QTc interval using concentration\u2010effect analysis and the effect of a meal on QTc to confirm assay sensitivity. Thirty\u2010two volunteers were randomly assigned to receive the active drug or a matching vehicle as placebo. Participants were dosed twice daily on days 1 to 3 (225 mg applied topically as a 7.5% solution 12 hours apart) and once on day 4. Pharmacokinetic and electrocardiogram assessments were performed after supratherapeutic doses. Assay sensitivity was successfully confirmed by using the food effect on the QTc interval. The results of this concentration\u2010QTc analysis demonstrate that cortexolone 17\u03b1\u2010propionate and its metabolite\/degradation product had no effect on the QTc interval in the concentration range tested.<\/jats:p>","DOI":"10.1002\/cpdd.935","type":"journal-article","created":{"date-parts":[[2021,5,4]],"date-time":"2021-05-04T07:00:21Z","timestamp":1620111621000},"page":"572-581","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["A Phase 1 Study to Investigate the Effects of Cortexolone 17\u03b1\u2010Propionate, Also Known as Clascoterone, on the QT Interval Using the Meal Effect to Demonstrate ECG Assay Sensitivity"],"prefix":"10.1002","volume":"10","author":[{"given":"J\u00f6rg","family":"T\u00e4ubel","sequence":"first","affiliation":[{"name":"Richmond Pharmacology Ltd  London United Kingdom"},{"name":"St George's University of London  London United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro","family":"Mazzetti","sequence":"additional","affiliation":[{"name":"Cassiopea SpA  Lainate Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Georg","family":"Ferber","sequence":"additional","affiliation":[{"name":"Statistik Georg Ferber GmbH  Riehen Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Burch","sequence":"additional","affiliation":[{"name":"Richmond Pharmacology Ltd  London United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Fernandes","sequence":"additional","affiliation":[{"name":"Richmond Pharmacology Ltd  London United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Avani","family":"Patel","sequence":"additional","affiliation":[{"name":"Richmond Pharmacology Ltd  London United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher S.","family":"Spencer","sequence":"additional","affiliation":[{"name":"Richmond Research Institute St George's University  London United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"Freier","sequence":"additional","affiliation":[{"name":"Richmond Research Institute St George's University  London United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claus","family":"Graff","sequence":"additional","affiliation":[{"name":"Department of Health Science and Technology Aalborg University  Aalborg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00f8rgen K.","family":"Kanters","sequence":"additional","affiliation":[{"name":"Department of Biomedical Sciences Kobenhavns Universitet  Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Camm","sequence":"additional","affiliation":[{"name":"St George's University of London  London United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,5,3]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1039\/C4MD00049H"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.4158\/EP11085.OR"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/1523-1747.ep12324390"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0378-5173(99)00359-2"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40257-019-00493-z"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2133.2011.10332.x"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.4161\/chan.2.2.6004"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.tcm.2017.07.012"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2016-1877"},{"issue":"6","key":"e_1_2_11_11_1","first-page":"356","article-title":"QT interval length in elderly prostatic cancer patients on anti\u2010testosterone treatment","volume":"17","author":"Lubart E","year":"2015","journal-title":"Isr Med Assoc J"},{"issue":"176","key":"e_1_2_11_12_1","article-title":"Prolonged QT intervals in isolated ACTH deficiency: Case Report and Mini Review of Literature","volume":"7","author":"Suzuki R","year":"2016","journal-title":"J Steroids Horm Sci"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40520-013-0168-9"},{"issue":"4","key":"e_1_2_11_14_1","article-title":"Cortexolone 17a\u2010propionate: preclinical profile of a new topical, skin selective, steroidal antiandrogen","volume":"66","author":"Celasco G","year":"2012","journal-title":"J Am Acad Dermatol"},{"key":"e_1_2_11_15_1","unstructured":"ICH E14 Guideline: The Clinical Evaluation of QT\/QTc Interval Prolongation and Proarrhythmic Potential for Non\u2010Antiarrhythmic Drugs Questions & Answers (R3) 2015 [2\/6\/2016]. 61134]. 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