{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T00:01:19Z","timestamp":1790035279259,"version":"4.0.1"},"reference-count":33,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T00:00:00Z","timestamp":1789948800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T00:00:00Z","timestamp":1789948800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"abstract":"<jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>This study aimed to evaluate the safety, tolerability and pharmacokinetics of a novel oral modified\u2010release psilocybin formulation (REL\u2010P11) in normal\u2010weight and overweight\/obese healthy adults and to assess its suitability for controlled, subperceptual exposure, in light of emerging evidence supporting serotonergic modulation in metabolic disorders.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Simulation\u2010based modelling compared predicted psilocin exposure with immediate\u2010release formulations. Then, a randomized, double\u2010blind, placebo\u2010controlled, single ascending dose Phase I study was conducted in eight normal\u2010weight and 32 overweight\/obese adults. Single oral doses of 0.5, 1.0, 1.5 and 2.0\u00a0mg of REL\u2010P11 were administered. Plasma psilocin concentrations were measured using liquid chromatography\u2013mass spectrometry, and pharmacokinetic parameters were derived using non\u2010compartmental analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Simulations indicated lower peak concentrations and prolonged absorption with the modified\u2010release formulation compared with immediate\u2010release psilocybin. No serious adverse events or adverse events of special interest (AESIs) occurred among REL\u2010P11\u2010treated participants, and no clinically meaningful treatment\u2010related changes were detected in the prespecified psychometric and safety assessments. Psilocin exposure increased proportionally with dose, with low interindividual variability. At the 2\u2010mg dose, pharmacokinetic parameters were broadly comparable between normal\u2010weight and overweight\/obese participants, and median time to peak concentration was approximately 2\u00a0h.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Low\u2010dose modified\u2010release psilocybin provides predictable systemic exposure without measurable psychoactive effects across body weight categories. While these properties, together with preclinical evidence, are of potential interest in the context of metabolic regulation, the present findings remain preliminary. Further clinical studies are warranted to determine whether the favourable pharmacokinetic profile observed with controlled subperceptual psilocybin dosing translates into clinically relevant pharmacological and therapeutic effects in metabolic and liver\u2010related disorders.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bcp.70839","type":"journal-article","created":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T23:10:43Z","timestamp":1790032243000},"source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetics and safety of a modified\u2010release psilocybin formulation: A SAD Phase I trial in normal\u2010weight and overweight\/obese participants"],"prefix":"10.1002","author":[{"given":"Anna","family":"Signor","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical and Pharmacological Sciences University of Padua  Padua Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefano","family":"Comai","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical and Pharmacological Sciences University of Padua  Padua Italy"},{"name":"Department of Psychiatry McGill University  Montreal QC Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gianfranco","family":"Pasut","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical and Pharmacological Sciences University of Padua  Padua Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Franco","family":"Folli","sequence":"additional","affiliation":[{"name":"Department of Health Sciences University of Milan  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Gentilucci","sequence":"additional","affiliation":[{"name":"MGGM Therapeutics  Kerhonkson New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Negar","family":"Gharavi","sequence":"additional","affiliation":[{"name":"BioPharma Services Inc.  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Dover Delaware USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Mattarei","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical and Pharmacological Sciences University of Padua  Padua Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo L.","family":"Manfredi","sequence":"additional","affiliation":[{"name":"MGGM Therapeutics  Kerhonkson New York USA"},{"name":"Neuroarbor Therapeutics Inc.  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