{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T05:44:25Z","timestamp":1790228665962,"version":"4.1.0"},"reference-count":17,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2023,3,1]],"date-time":"2023-03-01T00:00:00Z","timestamp":1677628800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2023,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The pharmacokinetics and safety of the novel herpes simplex virus helicase\u2010primase inhibitor pritelivir were evaluated in 5 phase 1 trials: a single\u2010ascending\u2010dose trial, 2 multiple\u2010ascending\u2010dose trials, a food\u2010effect trial, and an absolute bioavailability trial in healthy male subjects. One cohort of healthy female subjects was included in the single\u2010ascending\u2010dose trial. Pritelivir pharmacokinetics were linear up to 480\u00a0mg following single and up to 400\u00a0mg following multiple once\u2010daily doses. The half\u2010life ranged from 52 to 83\u00a0hours, and steady state was reached between 8 and 13\u00a0days. Maximum plasma concentration and area under the plasma concentration\u2013time curve from time 0 to the last quantifiable concentration were 1.5\u2010 and 1.1\u2010fold higher in female compared to male subjects. Absolute bioavailability was 72% under fasted conditions. Following a fatty diet, pritelivir time to maximum concentration was 1.5\u00a0hour delayed and maximum plasma concentration and area under the plasma concentration\u2013time curve from time 0 to the last quantifiable concentration were 33% and 16% higher, respectively. Pritelivir was safe and well tolerated up to 600\u00a0mg following single and up to 200\u00a0mg following multiple once\u2010daily doses. Considering a therapeutic dose of 100\u00a0mg once\u2010daily, pritelivir demonstrated a favorable safety and tolerability and pharmacokinetic profile in healthy subjects to support further development.<\/jats:p>","DOI":"10.1002\/cpdd.1241","type":"journal-article","created":{"date-parts":[[2023,3,2]],"date-time":"2023-03-02T06:49:51Z","timestamp":1677739791000},"page":"749-760","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["First\u2010in\u2010Human, Single\u2010 and Multiple\u2010Ascending\u2010Dose, Food\u2010Effect, and Absolute Bioavailability Trials to Assess the Pharmacokinetics, Safety, and Tolerability of Pritelivir, a Nonnucleoside Helicase\u2010Primase Inhibitor Against Herpes Simplex Virus in Healthy Subjects"],"prefix":"10.1002","volume":"12","author":[{"given":"Dirk","family":"Kropeit","sequence":"first","affiliation":[{"name":"Aicuris Anti\u2010infective Cures AG  Wuppertal 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