{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,14]],"date-time":"2026-01-14T06:12:11Z","timestamp":1768371131592,"version":"3.49.0"},"reference-count":17,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2017,12,18]],"date-time":"2017-12-18T00:00:00Z","timestamp":1513555200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Melinta Therapeutics, Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2018,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Delafloxacin, a fluoroquinolone, has activity against gram\u2010positive organisms including methicillin\u2010resistant <jats:italic>Staphylococcus aureus<\/jats:italic> and fluoroquinolone\u2010susceptible and \u2013resistant gram\u2010negative organisms. This study was conducted to determine delafloxacin pharmacokinetics after a single intravenous infusion or oral dose administration in subjects with varying degrees of renal function. The study was an open\u2010label, parallel\u2010group crossover study in subjects with normal renal function or with mild, moderate, or severe renal impairment. Subjects received 300\u00a0mg delafloxacin intravenously, placebo intravenously, and 400\u00a0mg delafloxacin orally in 3 periods separated by \u226514\u2010day washouts. Blood and urine pharmacokinetic parameters were calculated using noncompartmental methods. Delafloxacin total clearance decreased with decreasing renal function, with a corresponding increase in AUC<jats:sub>0\u2013\u221e<\/jats:sub>. After intravenous administration, mean total clearance was 13.7 and 7.07 L\/h, and mean AUC<jats:sub>0\u2013\u221e<\/jats:sub> was 22.6 and 45.0 \u03bcg\u00b7h\/mL in normal and severe renal subjects, respectively. Mean renal clearance as determined by urinary excretion was 6.03 and 0.44 L\/h in normal and severe renal impairment subjects, respectively. Total clearance exhibited linear relationships to eGFR and CL<jats:sub>CR<\/jats:sub>. Similar observations were found after oral administration of delafloxacin. Single doses of delafloxacin 300\u00a0mg intravenously and 400\u00a0mg orally were well tolerated in all groups. In conclusion, renal insufficiency has an effect on delafloxacin clearance; a dosing adjustment for intravenous dosing is warranted for patients with severe renal impairment (eGFR &lt; 30 mL\/min).<\/jats:p>","DOI":"10.1002\/jcph.1041","type":"journal-article","created":{"date-parts":[[2017,12,18]],"date-time":"2017-12-18T16:16:53Z","timestamp":1513613813000},"page":"514-521","source":"Crossref","is-referenced-by-count":28,"title":["Delafloxacin Pharmacokinetics in Subjects With Varying Degrees of Renal Function"],"prefix":"10.1002","volume":"58","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5852-606X","authenticated-orcid":false,"given":"Randall K.","family":"Hoover","sequence":"first","affiliation":[{"name":"Pharmacology Consultant  Bel Air MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"suffix":"Jr.","given":"Harry","family":"Alcorn","sequence":"additional","affiliation":[{"name":"DaVita Clinical Research  Minneapolis MN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Lawrence","sequence":"additional","affiliation":[{"name":"Melinta Therapeutics Inc.  Lincolnshire IL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susan K.","family":"Paulson","sequence":"additional","affiliation":[{"name":"Firma Clinical Research  Chicago IL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Megan","family":"Quintas","sequence":"additional","affiliation":[{"name":"Melinta Therapeutics Inc.  Lincolnshire IL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sue K.","family":"Cammarata","sequence":"additional","affiliation":[{"name":"Melinta Therapeutics Inc.  Lincolnshire IL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,12,18]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cis688"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/civ523"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s15010-015-0749-y"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.2217\/fmb.15.39"},{"key":"e_1_2_8_6_1","doi-asserted-by":"crossref","unstructured":"CammarataS GardovskisJ FarleyB et\u00a0al.Results of a global phase 3 study of delafloxacin (DLX) compared to vancomycin with aztreonam (VAN) in acute bacterial skin and skin structure infections (ABSSSI).2015.http:\/\/melinta.com\/wp-content\/uploads\/2016\/03\/IDWeek2015-complete_302_ABSSSI_study_results.pdf.","DOI":"10.1093\/ofid\/ofv133.493"},{"key":"e_1_2_8_7_1","unstructured":"O'RiordanW McManusA TerasJ et\u00a0al.A global phase 3 study of delafloxacin (DLX) compared to vancomycin\/ aztreonam (VAN\/AZ) in patients with acute bacterial skin and skin structure infections (ABSSSI).2016.http:\/\/melinta.com\/wp-content\/uploads\/2016\/10\/IDWEEK-1347-Baxdela-vs-VAN-AZ-302-Ph3-Results.pdf."},{"key":"e_1_2_8_8_1","unstructured":"Study to compare delafloxacin to moxifloxacin for the treatment of adults with community\u2010acquired bacterial pneumonia (DEFINE\u2010CABP).https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02679573?term=delafloxacin&rank=3. 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