{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T12:03:38Z","timestamp":1753877018036,"version":"3.41.2"},"reference-count":13,"publisher":"Oxford University Press (OUP)","license":[{"start":{"date-parts":[[2019,11,6]],"date-time":"2019-11-06T00:00:00Z","timestamp":1572998400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"name":"Forschungsfonds zur F\u00f6rderung exzellenter Nachwuchsforschender"},{"DOI":"10.13039\/100008375","name":"University of Basel","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008375","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Ivermectin is an older anthelminthic agent that is being studied more intensely given its potential for mass drug administration against scabies, malaria and other neglected tropical diseases. Its pharmacokinetics (PK) remain poorly characterized. Furthermore, the majority of PK trials are performed under fasted-state dosing conditions, and the effect of food is therefore not well known. To better plan and design field trials with ivermectin, a model that can account for both conditions would be valuable.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To develop a PK model and characterize the food effect with single oral doses of ivermectin.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Patients and methods<\/jats:title>\n                  <jats:p>We performed a population-based PK analysis of data pooled from two previous trials of a single dose of 12\u2009mg ivermectin, one with dosing after a high-fat breakfast (n=12) and one with fasted-state dosing (n=3).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The final model described concentration\u2013time profiles after fed and fasted dosing accurately, and estimated the food effect associated with relative bioavailability to 1.18 (95% CI 1.10\u20131.67).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>In this analysis, the effect of a high-fat breakfast compared with a fasted-state administration of a single oral dose of 12\u2009mg ivermectin was minimal.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jac\/dkz466","type":"journal-article","created":{"date-parts":[[2019,10,16]],"date-time":"2019-10-16T22:17:43Z","timestamp":1571264263000},"source":"Crossref","is-referenced-by-count":3,"title":["The effect of food on the pharmacokinetics of oral ivermectin"],"prefix":"10.1093","author":[{"given":"Urs","family":"Duthaler","sequence":"first","affiliation":[{"name":"Division of Clinical Pharmacology & Toxicology, Department of Biomedicine, University and University Hospital Basel, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rory","family":"Leisegang","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mats O","family":"Karlsson","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephan","family":"Kr\u00e4henb\u00fchl","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology & Toxicology, Department of Biomedicine, University and University Hospital Basel, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Felix","family":"Hammann","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology & Toxicology, Department of Biomedicine, University and University Hospital Basel, Switzerland"},{"name":"Clinical Pharmacology and Toxicology, Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland"},{"name":"Institute of Pharmacology, University of Bern, Bern, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2019,11,6]]},"reference":[{"key":"2019110607461209400_dkz466-B1","doi-asserted-by":"crossref","first-page":"1517","DOI":"10.1016\/S0140-6736(18)32321-3","article-title":"Efficacy and risk of harms of repeat ivermectin mass drug administrations for control of malaria (RIMDAMAL): a cluster-randomised trial","volume":"393","author":"Foy","year":"2019","journal-title":"Lancet"},{"key":"2019110607461209400_dkz466-B2","doi-asserted-by":"crossref","first-page":"388","DOI":"10.1002\/cpt.1219","article-title":"Pharmacokinetics-pharmacodynamics of high-dose ivermectin with dihydroartemisinin-piperaquine on mosquitocidal activity and QT-prolongation (IVERMAL)","volume":"105","author":"Smit","year":"2019","journal-title":"Clin Pharmacol Ther"},{"key":"2019110607461209400_dkz466-B3","doi-asserted-by":"crossref","first-page":"1642","DOI":"10.1093\/jac\/dkz083","article-title":"Pharmacokinetics of ascending doses of ivermectin in Trichuris trichiura-infected children aged 2-12 years","volume":"74","author":"Schulz","year":"2019","journal-title":"J Antimicrob Chemother"},{"key":"2019110607461209400_dkz466-B4","doi-asserted-by":"crossref","first-page":"161.","DOI":"10.1186\/s12936-017-1801-4","article-title":"Ivermectin to reduce malaria transmission I. Pharmacokinetic and pharmacodynamic considerations regarding efficacy and safety","volume":"16","author":"Chaccour","year":"2017","journal-title":"Malar J"},{"key":"2019110607461209400_dkz466-B5","doi-asserted-by":"crossref","first-page":"626","DOI":"10.1111\/bcp.13840","article-title":"Population pharmacokinetics of oral ivermectin in venous plasma and dried blood spots in healthy volunteers","volume":"85","author":"Duthaler","year":"2019","journal-title":"Br J Clin Pharmacol"},{"key":"2019110607461209400_dkz466-B6","doi-asserted-by":"crossref","first-page":"97","DOI":"10.1016\/j.actatropica.2013.03.019","article-title":"The lack of influence of food and local alcoholic brew on the blood level of Mectizan((R)) (ivermectin)","volume":"127","author":"Homeida","year":"2013","journal-title":"Acta Trop"},{"key":"2019110607461209400_dkz466-B7","doi-asserted-by":"crossref","first-page":"661","DOI":"10.1002\/cpt.1456","article-title":"Ivermectin dosing strategy to achieve equivalent exposure coverage in children and adults","volume":"106","author":"Brussee","year":"2019","journal-title":"Clin Pharmacol Ther"},{"key":"2019110607461209400_dkz466-B8","doi-asserted-by":"crossref","first-page":"e236.","DOI":"10.1371\/journal.pntd.0000236","article-title":"The effect of azithromycin on ivermectin pharmacokinetics\u2014a population pharmacokinetic model analysis","volume":"2","author":"El-Tahtawy","year":"2008","journal-title":"PLoS Negl Trop Dis"},{"key":"2019110607461209400_dkz466-B9","doi-asserted-by":"crossref","first-page":"42","DOI":"10.1208\/s12248-007-9000-9","article-title":"The pharmacokinetics and interactions of ivermectin in humans\u2014a mini-review","volume":"10","author":"Gonzalez Canga","year":"2008","journal-title":"AAPS J"},{"key":"2019110607461209400_dkz466-B10","doi-asserted-by":"crossref","first-page":"1122","DOI":"10.1177\/009127002401382731","article-title":"Safety, tolerability, and pharmacokinetics of escalating high doses of ivermectin in healthy adult subjects","volume":"42","author":"Guzzo","year":"2002","journal-title":"J Clin Pharmacol"},{"key":"2019110607461209400_dkz466-B11","doi-asserted-by":"crossref","first-page":"1030","DOI":"10.1111\/1346-8138.13321","article-title":"Effect of high-fat meal intake on the pharmacokinetic profile of ivermectin in Japanese patients with scabies","volume":"43","author":"Miyajima","year":"2016","journal-title":"J Dermatol"},{"key":"2019110607461209400_dkz466-B12","doi-asserted-by":"crossref","first-page":"18","DOI":"10.1016\/j.jpba.2019.04.007","article-title":"Development and validation of an LC-MS\/MS method for the analysis of ivermectin in plasma, whole blood, and dried blood spots using a fully automatic extraction system","volume":"172","author":"Duthaler","year":"2019","journal-title":"J Pharm Biomed Anal"},{"key":"2019110607461209400_dkz466-B13","doi-asserted-by":"crossref","first-page":"711","DOI":"10.1007\/s10928-007-9066-0","article-title":"Implementation of a transit compartment model for describing drug absorption in pharmacokinetic studies","volume":"34","author":"Savic","year":"2007","journal-title":"J Pharmacokinet Pharmacodyn"}],"container-title":["Journal of Antimicrobial Chemotherapy"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/academic.oup.com\/jac\/advance-article-pdf\/doi\/10.1093\/jac\/dkz466\/30438178\/dkz466.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"http:\/\/academic.oup.com\/jac\/advance-article-pdf\/doi\/10.1093\/jac\/dkz466\/30438178\/dkz466.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2019,11,6]],"date-time":"2019-11-06T12:46:27Z","timestamp":1573044387000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jac\/advance-article\/doi\/10.1093\/jac\/dkz466\/5613771"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,11,6]]},"references-count":13,"URL":"https:\/\/doi.org\/10.1093\/jac\/dkz466","relation":{},"ISSN":["0305-7453","1460-2091"],"issn-type":[{"type":"print","value":"0305-7453"},{"type":"electronic","value":"1460-2091"}],"subject":[],"published":{"date-parts":[[2019,11,6]]},"article-number":"dkz466"}}