{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T13:53:28Z","timestamp":1782136408586,"version":"3.54.5"},"reference-count":14,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2018,3,26]],"date-time":"2018-03-26T00:00:00Z","timestamp":1522022400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2018,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Delafloxacin, a fluoroquinolone, has activity against Gram\u2010positive organisms including methicillin\u2010resistant <jats:italic>S aureus<\/jats:italic> and fluoroquinolone\u2010susceptible and \u2010resistant Gram\u2010negative organisms. The intravenous formulation of delafloxacin contains the excipient sulfobutylether\u2010\u03b2\u2010cyclodextrin (SBECD), which is eliminated by renal filtration. This study examined the pharmacokinetics and safety of SBECD after single intravenous (IV) infusions in subjects with renal impairment. The study was an open\u2010label, parallel\u2010group, crossover study in subjects with normal renal function or mild, moderate, or severe renal impairment, and those with end\u2010stage renal disease undergoing hemodialysis. Subjects received 300\u00a0mg delafloxacin IV or placebo IV, containing 2400 mg SBECD, in 2 periods separated by \u226514\u2010day washouts. SBECD total clearance decreased with decreasing renal function, with a corresponding increase in area under the concentration\u2010time curve (AUC<jats:sub>0\u2010\u221e<\/jats:sub>). After IV delafloxacin 300 mg administration, SBECD mean total clearance was 6.28 and 1.24 L\/h, mean AUC<jats:sub>0\u2010\u221e<\/jats:sub> was 387 and 2130 h\u00b7\u03bcg\/mL, and mean renal clearance was 5.36 and 1.14 L\/h in normal and severe renal subjects, respectively. Similar values were obtained after IV placebo administration. In subjects with end\u2010stage renal disease, delafloxacin 300 mg IV produced mean SBECD AUC<jats:sub>0\u201048<\/jats:sub> values of 2715 and 7861 h\u00b7\u03bcg\/mL when dosed before and after hemodialysis, respectively. Total SBECD clearance exhibited linear relationships to estimated glomerular filtration rate and creatinine clearance. Single doses of IV delafloxacin 300 mg and IV placebo were well tolerated in all groups. In conclusion, decreasing renal function causes reduced SBECD clearance and increased exposures, but SBECD continues to exhibit a good safety and tolerability profile in IV formulations.<\/jats:p>","DOI":"10.1002\/jcph.1077","type":"journal-article","created":{"date-parts":[[2018,3,26]],"date-time":"2018-03-26T14:08:36Z","timestamp":1522073316000},"page":"814-822","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":35,"title":["Clinical Pharmacokinetics of Sulfobutylether\u2010\u03b2\u2010Cyclodextrin in Patients With Varying Degrees of Renal Impairment"],"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":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr","given":"Harry","family":"Alcorn","sequence":"additional","affiliation":[{"name":"DaVita Clinical Research  Minneapolis MN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Lawrence","sequence":"additional","affiliation":[{"name":"Melinta Therapeutics, Inc  Lincolnshire IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan K.","family":"Paulson","sequence":"additional","affiliation":[{"name":"Firma Clinical Research  Chicago IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megan","family":"Quintas","sequence":"additional","affiliation":[{"name":"Melinta Therapeutics, Inc  Lincolnshire IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David R.","family":"Luke","sequence":"additional","affiliation":[{"name":"Melinta Therapeutics, Inc  Lincolnshire IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sue K.","family":"Cammarata","sequence":"additional","affiliation":[{"name":"Melinta Therapeutics, Inc  Lincolnshire IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,3,26]]},"reference":[{"key":"e_1_2_6_2_1","unstructured":"Delafloxacin Prescribing Information.https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/208610s000 208611s000lbl.pdf. Accessed August 18 2017."},{"key":"e_1_2_6_3_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 bactyerial skin and skin structure infections (ABSSSI). Melinta Therapeutics Web Site.http:\/\/melinta.com\/wp-content\/uploads\/2016\/10\/IDWEEK-1347-Baxdela-vs-VAN-AZ-302-Ph3-Results.pdf. Accessed August 18 2017."},{"key":"e_1_2_6_4_1","unstructured":"BeasleyR OguchiG LiangS LawrenceL CammarataS.Delafloxacin (DLX) is effective and well\u2010tolerated in treatment of patients with renal impairment with acute bacterial skin and skin structure infections (ABSSSI) versus vancomycin\/aztreonam (VAN\/AZ).www.Melinta.com.http:\/\/melinta.com\/wp-content\/uploads\/2017\/04\/ECCMID-2017-Renal.pdf. Accessed August 18 2017."},{"key":"e_1_2_6_5_1","unstructured":"Study to compare delafloxacin to moxifloxacin for the treatment of adults with community\u2010acquired bacterial pneumonia.www.clinicaltrials.gov.https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02679573?term=delafloxacin&rank=3. Accessed August 18 2017."},{"key":"e_1_2_6_6_1","unstructured":"Captisol\u00aedosing in clinical and commercial products. Ligand Technology.www.Captisol.com.http:\/\/www.captisol.com\/. Accessed August 18 2017."},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/jps.22109"},{"key":"e_1_2_6_8_1","article-title":"Delafloxacin pharmacokinetics in subjects with varying degrees of renal function","author":"Hoover RK","journal-title":"J Clin Pharmacol"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-130-6-199903160-00002"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1159\/000180580"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.2165\/00044011-200828070-00002"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/ndt\/gfr472"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01540-09"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13054-015-0753-8"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1186\/1472-6904-6-6"}],"container-title":["The Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fjcph.1077","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcph.1077","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jcph.1077","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcph.1077","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,9]],"date-time":"2023-09-09T23:20:37Z","timestamp":1694301637000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/jcph.1077"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,3,26]]},"references-count":14,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2018,6]]}},"alternative-id":["10.1002\/jcph.1077"],"URL":"https:\/\/doi.org\/10.1002\/jcph.1077","archive":["Portico"],"relation":{},"ISSN":["0091-2700","1552-4604"],"issn-type":[{"value":"0091-2700","type":"print"},{"value":"1552-4604","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,3,26]]},"assertion":[{"value":"2017-10-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2017-12-11","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-03-26","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}