{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T14:18:00Z","timestamp":1783606680147,"version":"3.55.0"},"reference-count":21,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2016,9,22]],"date-time":"2016-09-22T00:00:00Z","timestamp":1474502400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Paratek Pharmaceuticals"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2017,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Omadacycline is a first\u2010in\u2010class aminomethylcycline antibiotic being evaluated in phase 3 studies as oral and intravenous monotherapy for bacterial infections. This was a phase 1, randomized, open\u2010label, 4\u2010period, crossover study that evaluated the effect of food consumption on the bioavailability of omadacycline. Healthy participant were randomized to 1 of 4 sequences, which included the following predose conditions in different orders (A) \u22656\u2010hour fast, (B) high\u2010fat, nondairy meal 4 hours before dosing, (C) high\u2010fat, nondairy meal 2 hours before dosing, and (D) high\u2010fat meal containing dairy 2 hours before dosing. Participants received a single 300\u2010mg oral dose of omadacycline during each treatment period; periods were separated by \u22655 days. Blood samples for pharmacokinetic (PK) analysis were collected over 24 hours after each dose, and safety assessments were performed during each treatment period. Least\u2010squares mean and 90% confidence intervals were compared for fed state vs fasted state. Thirty\u2010one participants were included in the PK analysis. Fasted AUC<jats:sub>0\u2010\u221e<\/jats:sub>, AUC<jats:sub>0\u2010t<\/jats:sub>, and AUC<jats:sub>0\u201024<\/jats:sub> were 10.2, 7.2, and 7.2 \u03bcg\u00b7h\/mL, respectively, and C<jats:sub>max<\/jats:sub> was 0.6 \u03bcg\/mL. Compared with a fasted dose, bioavailability was reduced by 15% to 17% by a nondairy meal 4 hours before dosing, 40% to 42% by a nondairy meal 2 hours before dosing, and 59% to 63% for a dairy meal 2 hours before dosing. Two participants experienced adverse events (mild nausea, mild somnolence). A 300\u2010mg oral dose of omadacycline administered within 2 to 4 hours after food had reduced bioavailability compared with the fasted state. Oral omadacycline should be administered in a fasted state.<\/jats:p>","DOI":"10.1002\/jcph.814","type":"journal-article","created":{"date-parts":[[2016,8,19]],"date-time":"2016-08-19T09:16:55Z","timestamp":1471598215000},"page":"321-327","source":"Crossref","is-referenced-by-count":40,"title":["Effect of Food on the Bioavailability of Omadacycline in Healthy Participants"],"prefix":"10.1002","volume":"57","author":[{"given":"Evan","family":"Tzanis","sequence":"first","affiliation":[{"name":"Paratek Pharmaceuticals  King of Prussia PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy","family":"Manley","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals  King of Prussia PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Villano","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals  King of Prussia PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S. Ken","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals  King of Prussia PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Bai","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals  King of Prussia PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evan","family":"Loh","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals  King of Prussia PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2016,9,22]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01536-15"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01066-13"},{"key":"e_1_2_6_4_1","unstructured":"DuboisJ DuboisM MartelJ\u2010F TanakaSK. In vitro activity of omadacycline againstLegionella pneumophila. Presented at 55th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy; September 17\u201021 2015; San Diego CA. Poster P\u20101992."},{"key":"e_1_2_6_5_1","unstructured":"FlammRK RhombergPR HubandMD FarrellDJ.Activity of omadacycline tested against Enterobacteriaceae causing urinary tract infections from a global surveillance program (2014). Presented at 55th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy; September 17\u201021 2015; San Diego CA. Poster C\u2010614."},{"key":"e_1_2_6_6_1","unstructured":"FlammRK RhombergPR HubandMD FarrellDJ.Activity of omadacycline tested againstStreptococcus pneumoniaefrom a global surveillance program (2014). Presented at 55th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy; September 17\u201021 2015; San Diego CA. Poster C\u2010554."},{"key":"e_1_2_6_7_1","unstructured":"FlammRK RhombergPR HubandMD FarrellDJ.Activity of omadacycline tested againstStaphylococcus aureusfrom a global surveillance program (2014). Presented at 55th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy; September 17\u201021 2015; San Diego CA. Poster F\u2010289."},{"key":"e_1_2_6_8_1","unstructured":"KimO LeahyRG TraczewskiM MaconeA SteenbergenJ TanakaSK.Activity and efficacy of omadacycline againstClostridium difficile. Presented at 26th European Congress on Clinical Microbiology and Infectious Diseases (ECCMID); April 9\u201012 2016; Amsterdam the Netherlands. Poster P\u20101325."},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01242-13"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00948-12"},{"key":"e_1_2_6_11_1","unstructured":"NoelGJ DraperMP HaitH TanakaSK.Safety and efficacy of PTK 0796 (omadacycline) as treatment of complicated skin and soft tissue infection (cSSTI). Presented at 23rd European Congress on Clinical Microbiology and Infectious Diseases (ECCMID); March 31\u2010April 3 2012 London UK. Poster P\u2010694."},{"key":"e_1_2_6_12_1","unstructured":"TanakaSK ChitraS Garrity\u2010RyanL TzanisE LohE.A pooled analysis of two randomized multicenter evaluator\u2010blind studies comparing the safety and efficacy of omadacycline and linezolid for the treatment of complicated skin and skin structure infections. Presented at 26th European Congress on Clinical Microbiology and Infectious Diseases (ECCMID); April 9\u201012 2016 Amsterdam the Netherlands. Poster P\u20101326."},{"key":"e_1_2_6_13_1","unstructured":"SunH MaiettaR MachineniS et\u00a0al.A single\u2010dose study to evaluate the pharmacokinetics safety and tolerability of multiple formulations of PTK 0796 in healthy subjects. Presented at 21st European Congress on Clinical Microbiology and Infectious Diseases (ECCMID); May 7\u201011 2011 Milan Italy. Poster P\u20101423."},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1080\/00498254.2016.1213465"},{"key":"e_1_2_6_15_1","unstructured":"TanakaSK TzanisE VillanoS.Effect of age and gender on the pharmacokinetics of the oral and IV omadacycline A new class of aminomethylcyclines. Presented at 26th European Congress on Clinical Microbiology and Infectious Diseases (ECCMID); April 9\u201012 2016 Amsterdam the Netherlands. Poster P\u20101318."},{"key":"e_1_2_6_16_1","unstructured":"TingL KovacsSJ PrestgaardJ et\u00a0al.An open\u2010label study of the pharmacokinetics and safety of single IV and oral doses of omadacycline in subjects with mild moderate and severe hepatic impairment. Presented at 52nd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy; September 9\u201012 2012; Washington DC. Poster A\u20101282."},{"key":"e_1_2_6_17_1","unstructured":"TingL SunH KovacsSJ KlausnerK TanakaSK.Pharmacokinetics of intravenous and oral PTK796 a new aminomethylcycline antibiotic. Presented at 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy; September 12\u201015 2010; Boston MA. Abstract K\u2010124."},{"key":"e_1_2_6_18_1","unstructured":"Department of Health and Human Services Food and Drug Administration (DHHS) Center for Drug Evaluation and Research (US). Guidance for industry: food\u2010effect bioavailability and fed bioequivalence studies. 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