{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,21]],"date-time":"2025-10-21T10:11:59Z","timestamp":1761041519034,"version":"build-2065373602"},"reference-count":29,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2012,1,6]],"date-time":"2012-01-06T00:00:00Z","timestamp":1325808000000},"content-version":"vor","delay-in-days":523,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accpjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacotherapy"],"published-print":{"date-parts":[[2010,8]]},"abstract":"<jats:p><jats:bold>Study Objective<\/jats:bold>. To assess the safety and tolerability, and the effect of sex on the pharmacokinetic disposition, of a single intravenous dose of telavancin 10 mg\/kg in elderly (\u2265 65 yrs) subjects.<\/jats:p><jats:p><jats:bold>Design<\/jats:bold>. Phase I, open\u2010label, single\u2010dose, sex\u2010stratified study.<\/jats:p><jats:p><jats:bold>Setting.<\/jats:bold> Clinical research unit.<\/jats:p><jats:p><jats:bold>Subjects.<\/jats:bold> Eight healthy men and eight healthy women (mean \u00b1 SD ages 70.6 \u00b1 6.1 and 70.8 \u00b1 5.5 yrs, respectively).<\/jats:p><jats:p><jats:bold>Intervention.<\/jats:bold> Each subject received a 60\u2013minute intravenous infusion of telavancin 10 mg\/kg.<\/jats:p><jats:p><jats:bold>Measurements and Main Results<\/jats:bold>. For the pharmacokinetic analysis, blood samples were collected before drug administration and at regular intervals up to 48 hours after the start of the infusion. Telavancin plasma concentrations were determined by liquid chromatography with tandem mass spectrometric detection. Pharmacokinetic parameters of telavancin were determined by noncompartmental analysis. Standard clinical laboratory tests and electrocardiograms were used to assess safety and tolerability. The telavancin plasma concentration\u2010time curves and pharmacokinetic parameters for both sexes were comparable. Pooled mean \u00b1 SD clearance, half\u2010life, and volume of distribution at the steady state were 12.2 \u00b1 1.4 ml\/hour\/kg, 9.3 \u00b1 1.3 hours, and 156 \u00b1 12 ml\/kg, respectively. The pooled mean \u00b1 SD plasma concentration of telavancin 24 hours postdose was 10.8 \u00b1 1.6 \u03bcg\/ml, exceeding the telavancin minimum inhibitory concentration required to inhibit the growth of 90% of organisms for key gram\u2010positive pathogens (0.5 \u03bcg\/ml). Ten (63%) of the 16 subjects reported at least one adverse event, most of which were mild; no serious adverse events were noted in this study. No clinically significant changes in vital signs, physical examinations, electrocardiograms, or clinical biochemistry profiles were observed.<\/jats:p><jats:p><jats:bold>Conclusion<\/jats:bold>. The pharmacokinetic parameters of telavancin were similar between elderly men and women and comparable to historical results in healthy young subjects. No evidence was found to support telavancin dosage adjustment based on age or sex.<\/jats:p>","DOI":"10.1592\/phco.30.8.806","type":"journal-article","created":{"date-parts":[[2010,7,23]],"date-time":"2010-07-23T09:29:13Z","timestamp":1279877353000},"page":"806-811","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":22,"title":["Single\u2010Dose Pharmacokinetics and Tolerability of Telavancin in Elderly Men and Women"],"prefix":"10.1002","volume":"30","author":[{"given":"Michael R.","family":"Goldberg","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shekman L.","family":"Wong","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeng\u2010Pyng","family":"Shaw","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael M.","family":"Kitt","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steven L.","family":"Barriere","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2012,1,6]]},"reference":[{"key":"e_1_2_1_2_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.49.3.1127-1134.2005"},{"key":"e_1_2_1_3_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.47.11.3602-3604.2003"},{"key":"e_1_2_1_4_2","doi-asserted-by":"publisher","DOI":"10.1086\/429914"},{"key":"e_1_2_1_5_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.50.3.862-867.2006"},{"key":"e_1_2_1_6_2","doi-asserted-by":"publisher","DOI":"10.1086\/587896"},{"issue":"7","key":"e_1_2_1_7_2","first-page":"S14","article-title":"Telavancin for hospital\u2010acquired pneumonia, including ventilator\u2010associated pneumonia: the ATTAIN studies [abstract 75]. Poster presented at the 18th European congress of clinical microbiology and infectious diseases, Barcelona, Spain, April 19, 2008","volume":"14","author":"Rubinstein E.","year":"2008","journal-title":"Clin Microbiol Infect"},{"key":"e_1_2_1_8_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.49.1.195-201.2005"},{"key":"e_1_2_1_9_2","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkn273"},{"key":"e_1_2_1_10_2","unstructured":"BarriereS. ShawJP SeroogyJ. SpencerE. KittM.Pharmacokinetics (PK) & safety of a new antibacterial TD\u20106424 (TD) in healthy subjects [abstract A\u201020]. Presented at the 43rd annual interscience conference on antimicrobial agents and chemotherapy Chicago IL September 1417 2003."},{"key":"e_1_2_1_11_2","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-144-5-200603070-00006"},{"key":"e_1_2_1_12_2","doi-asserted-by":"publisher","DOI":"10.1086\/499632"},{"key":"e_1_2_1_13_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.298.15.1763"},{"key":"e_1_2_1_14_2","unstructured":"Center for Drug Evaluation and Research.Guidance for industry: E6 good clinical practice: consolidated guidance April 2006. Available fromwww.fda.govcderguidance959fnl.pdf. Accessed October 26 2007."},{"key":"e_1_2_1_15_2","doi-asserted-by":"publisher","DOI":"10.1177\/0091270004266620"},{"key":"e_1_2_1_16_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1542-474X.2003.08413.x"},{"key":"e_1_2_1_17_2","doi-asserted-by":"publisher","DOI":"10.1159\/000180580"},{"key":"e_1_2_1_18_2","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-199920020-00002"},{"key":"e_1_2_1_19_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.48.8.3043-3050.2004"},{"key":"e_1_2_1_20_2","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkh156"},{"key":"e_1_2_1_21_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01641-07"},{"key":"e_1_2_1_22_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00100-07"},{"key":"e_1_2_1_23_2","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkn124"},{"key":"e_1_2_1_24_2","unstructured":"Theravance Inc.Data on file. South San Francisco CA; 2006 2008."},{"key":"e_1_2_1_25_2","unstructured":"SamaraE. GoldbergM. ShawJP et al.Population pharmacokinetics of telavancin in patients with complicated skin and soft tissue infections [abstract A\u201046]. Presented at the 47th annual interscience conference on antimicrobial agents and chemotherapy Chicago IL September 1720 2007."},{"key":"e_1_2_1_26_2","unstructured":"SamaraE. GoldbergM. ShawJP et al.Population pharmacokinetics of telavancin in noninfected subjects [abstract A\u201045]. Presented at the 47th annual interscience conference on antimicrobial agents and chemotherapy Chicago IL September 1720 2007."},{"key":"e_1_2_1_27_2","unstructured":"Theravance Inc.Data on file. South San Francisco CA;2006."},{"key":"e_1_2_1_28_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.exger.2004.05.011"},{"key":"e_1_2_1_29_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.50.2.788-790.2006"},{"key":"e_1_2_1_30_2","unstructured":"Astellas Pharma Global Development Inc.and Theravance Inc. VIBATIV prescribing information. Available fromwww.vibativ.com. Accessed December 14 2009."}],"container-title":["Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1592%2Fphco.30.8.806","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accpjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1592\/phco.30.8.806","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,21]],"date-time":"2025-10-21T09:51:16Z","timestamp":1761040276000},"score":1,"resource":{"primary":{"URL":"https:\/\/accpjournals.onlinelibrary.wiley.com\/doi\/10.1592\/phco.30.8.806"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2010,8]]},"references-count":29,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2010,8]]}},"alternative-id":["10.1592\/phco.30.8.806"],"URL":"https:\/\/doi.org\/10.1592\/phco.30.8.806","archive":["Portico"],"relation":{},"ISSN":["0277-0008","1875-9114"],"issn-type":[{"type":"print","value":"0277-0008"},{"type":"electronic","value":"1875-9114"}],"subject":[],"published":{"date-parts":[[2010,8]]},"assertion":[{"value":"2012-01-06","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}