{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,28]],"date-time":"2026-03-28T21:14:01Z","timestamp":1774732441590,"version":"3.50.1"},"reference-count":20,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2024,6,20]],"date-time":"2024-06-20T00:00:00Z","timestamp":1718841600000},"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":[[2024,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>N\u2010Acetyl\u2010D\u2010mannosamine (ManNAc) is an endogenous monosaccharide and precursor of N\u2010acetylneuraminic acid (Neu5Ac), a critical sialic acid. ManNAc is currently under clinical development to treat GNE myopathy, a rare muscle\u2010wasting disease. In this randomized, open\u2010label, 2\u2010sequence, crossover study, 16 healthy women and men were administered a single oral dose of ManNAc under fasting and fed conditions. Blood samples were collected for 48\u00a0hours after dosing for quantification of plasma ManNAc and Neu5Ac concentrations. Noncompartmental pharmacokinetic and deconvolution analyses were performed using baseline\u2010corrected plasma concentration data. Administration of ManNAc in the fed state resulted in a 1.6\u2010fold increase in ManNAc exposure, compared to fasting conditions. A concurrent increase in Neu5Ac exposure was observed in the presence of food. Deconvolution analysis indicated that the findings were attributed to prolonged absorption rather than an enhanced rate of absorption. The impact of food on ManNAc pharmacokinetics was greater in women than men (fed\/fasted area under the concentration\u2010time curve from time 0 to infinity mean ratio: 198% compared to 121%). It is hypothesized that the presence of food slows gastric emptying, allowing a gradual release of ManNAc into the small intestine, translating into improved ManNAc absorption. The results suggest that taking ManNAc with food may enhance its therapeutic activity and\/or reduce the daily dosage requirement.<\/jats:p>","DOI":"10.1002\/cpdd.1433","type":"journal-article","created":{"date-parts":[[2024,6,20]],"date-time":"2024-06-20T11:49:17Z","timestamp":1718884157000},"page":"876-883","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Impact of Food on the Oral Absorption of N\u2010Acetyl\u2010D\u2010Mannosamine in Healthy Men and Women"],"prefix":"10.1002","volume":"13","author":[{"given":"Allan M.","family":"Evans","sequence":"first","affiliation":[{"name":"UniSA Clinical &amp; Health Sciences University of South Australia  Adelaide SA Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gianfranco","family":"Fornasini","sequence":"additional","affiliation":[{"name":"Leadiant Biosciences, Inc.  Rockville MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tahlia R.","family":"Meola","sequence":"additional","affiliation":[{"name":"UniSA Clinical &amp; Health Sciences University of South Australia  Adelaide SA Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William A.","family":"Gahl","sequence":"additional","affiliation":[{"name":"Medical Genetics Branch National Human Genome Research Institute National Institutes of Health  Bethesda MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marjan","family":"Huizing","sequence":"additional","affiliation":[{"name":"Medical Genetics Branch National Human Genome Research Institute National Institutes of Health  Bethesda MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas M.","family":"Polasek","sequence":"additional","affiliation":[{"name":"Certara  Princeton NJ USA"},{"name":"Centre for Medicine Use and Safety Monash University  Melbourne Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephanie E.","family":"Reuter","sequence":"additional","affiliation":[{"name":"UniSA Clinical &amp; Health Sciences University of South Australia  Adelaide SA Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,6,20]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/humu.22583"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.nmd.2014.03.004"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/211976a0"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10719-006-9019-7"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1172\/JCI30954"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/nm.1956"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ymgme.2012.10.011"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/0167-4889(85)90107-7"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ymgme.2017.04.010"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41436-021-01259-x"},{"key":"e_1_2_10_12_1","volume-title":"Guidance for Industry; Food\u2010Effect Bioavailability and Fed Bioequivalence Studies","author":"Food and Drug Administration","year":"2002"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jchromb.2015.07.018"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2020.00997"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-200342020-00001"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40268-021-00343-6"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejps.2019.04.003"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/0163-7258(89)90019-3"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-017-0832-z"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/s002590050298"},{"issue":"7","key":"e_1_2_10_21_1","first-page":"1204","article-title":"Gender\u2010related differences in gastric emptying","volume":"28","author":"Datz FL","year":"1987","journal-title":"J Nucl Med"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1433","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,8,1]],"date-time":"2024-08-01T11:56:55Z","timestamp":1722513415000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.1433"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,6,20]]},"references-count":20,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2024,8]]}},"alternative-id":["10.1002\/cpdd.1433"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.1433","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,6,20]]},"assertion":[{"value":"2024-01-08","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-05-14","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-06-20","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}