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Here, we report the results from two phase I studies in which the pharmacokinetics (PK), safety, and efficacy of cedirogant in healthy participants and patients with moderate to severe chronic plaque psoriasis were evaluated. The studies consisted of single (20\u2013750\u2009mg) and multiple (75\u2013375\u2009mg once\u2010daily [q.d.]) ascending dose designs, with effect of food and itraconazole on cedirogant exposure also evaluated. Safety and PK were evaluated for both healthy participants and psoriasis patients, and efficacy was assessed in psoriasis patients. Following single and multiple doses, cedirogant mean terminal half\u2010life ranged from 16 to 28\u2009h and median time to reach maximum plasma concentration ranged from 2 to 5\u2009h across both populations. Cedirogant plasma exposures were dose\u2010proportional after single doses and less than dose\u2010proportional from 75 to 375\u2009mg q.d. doses. Steady\u2010state concentrations were achieved within 12\u2009days. Accumulation ratios ranged from approximately 1.2 to 1.8 across tested doses. Food had minimal effect and itraconazole had limited impact on cedirogant exposure. No discontinuations or serious adverse events due to cedirogant were recorded. Psoriasis Area and Severity Index (PASI) and Self\u2010Assessment of Psoriasis Symptoms (SAPS) assessments demonstrated numerical improvement with treatment of cedirogant 375\u2009mg q.d. compared with placebo. The PK, safety, and efficacy profiles of cedirogant supported advancing it to phase II clinical trial in psoriasis patients.<\/jats:p>","DOI":"10.1111\/cts.13682","type":"journal-article","created":{"date-parts":[[2023,12,19]],"date-time":"2023-12-19T12:00:08Z","timestamp":1702987208000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Pharmacokinetics, safety, and efficacy of cedirogant from phase I studies in healthy participants and patients with chronic plaque psoriasis"],"prefix":"10.1111","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0959-2025","authenticated-orcid":false,"given":"Mohamed\u2010Eslam F.","family":"Mohamed","sequence":"first","affiliation":[{"name":"Clinical Pharmacology AbbVie Inc.  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