{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T09:04:22Z","timestamp":1785229462550,"version":"3.55.0"},"reference-count":29,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2015,2,9]],"date-time":"2015-02-09T00:00:00Z","timestamp":1423440000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2015,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>To assess the effect of age and gender on the pharmacokinetics (PK) of the ghrelin receptor agonist anamorelin.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Three demographic cohorts of healthy subjects were enrolled in this single\u2010center, open\u2010label study. Subjects received a single oral dose (25\u2009mg) of anamorelin HCl. Serial blood samples were collected over 24\u2009hours to assess anamorelin PK and circulating growth hormone (GH) levels. Data were compared with a reference cohort.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Anamorelin was rapidly absorbed in all cohorts; peak concentrations were observed 30\u201345\u2009minutes and 2\u20134\u2009hours post\u2010dose, which declined biexponentially with mean terminal half\u2010lives of 6\u20137\u2009hours. An age effect on C<jats:sub>max<\/jats:sub> and AUC<jats:sub>\u221e<\/jats:sub> was not apparent; however, mean AUC<jats:sub>\u221e<\/jats:sub> values were approximately 1.8\u20131.9\u2010fold higher in the female cohorts than in the reference male cohort. GH increase was rapid and virtually identical in both sexes, though attenuated in elderly subjects. No clinically significant safety or tolerability findings were observed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>While PK parameters do suggest higher exposure in females, this effect is considered to be modest given the variability of the 6\u20138 subjects per cohort. Moreover, no such effect was observed in the pharmacodynamic responses, thus, dose adjustment for age and gender is considered unnecessary.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cpdd.175","type":"journal-article","created":{"date-parts":[[2014,11,25]],"date-time":"2014-11-25T09:55:07Z","timestamp":1416909307000},"page":"112-120","source":"Crossref","is-referenced-by-count":15,"title":["An open\u2010label clinical trial of the effects of age and gender on the pharmacodynamics, pharmacokinetics and safety of the ghrelin receptor agonist anamorelin"],"prefix":"10.1002","volume":"4","author":[{"given":"Philip T.","family":"Leese","sequence":"first","affiliation":[{"name":"Quintiles Phase I Services, Inc. Overland Park KS USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John M.","family":"Trang","sequence":"additional","affiliation":[{"name":"PK\/PD International, Inc. Tucson AZ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert A.","family":"Blum","sequence":"additional","affiliation":[{"name":"Buffalo Clinical Research Center LLC Buffalo NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eleanor","family":"de Groot","sequence":"additional","affiliation":[{"name":"Helsinn Therapeutics (US), Inc. Bridgewater NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2015,2,9]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.315.7117.1219"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-009-0772-6"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1152\/physrev.00016.2008"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clnu.2008.06.013"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(10)70218-7"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0149-2918(05)80001-3"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11864-010-0127-z"},{"key":"e_1_2_7_9_1","first-page":"0808","article-title":"Cancer anorexia\u2010cachexia syndrome (CACS) is under\u2010recognized among patients with metastatic non\u2010small cell lung cancer (MNSCLC)","volume":"21","author":"Benner A","year":"2013","journal-title":"Support Care Cancer"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.2012.734297"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.7861\/clinmedicine.6-2-140"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.mce.2011.02.012"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1517\/14712598.2013.727390"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.2217\/fon.14.14"},{"key":"e_1_2_7_15_1","article-title":"Anamorelin for patients with cancer cachexia: an integrated analysis of two phase 2, randomised, placebo\u2010controlled, double\u2010blind trials","author":"Garcia JM","year":"2014","journal-title":"The Lancet Oncol"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-012-1500-1"},{"key":"e_1_2_7_17_1","first-page":"1316","article-title":"Anamorelin's effect on bone mass: beyond the expected outcomes in non\u2010small cell lung (NSCLC) cancer cachexia","volume":"49","author":"Lu M","year":"2013","journal-title":"Eur J Cancer"},{"key":"e_1_2_7_18_1","first-page":"abstr 03\u2010010","article-title":"Pharmacokinetic (PK) profile of RC\u20101291, A novel oral ghrelin mimetic for the treatment of cancer anorexia\/cachexia","volume":"14","author":"Blum R","year":"2006","journal-title":"Support Care Cancer"},{"key":"e_1_2_7_19_1","first-page":"abstr\u201003\u2010009","article-title":"Biological activity of RC\u20101291, a novel ghrelin mimetic for cancer anorexia\/cachexia: results from a phase I randomized, double\u2010blind, placebo\u2010controlled trial in healthy volunteers","volume":"14","author":"Kumor K","year":"2006","journal-title":"Support Care Cancer"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1634\/theoncologist.12-5-594"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ghir.2008.12.003"},{"key":"e_1_2_7_22_1","unstructured":"Clinicaltrials.gov. Safety and efficacy of anamorelin HCl in patients with non\u2010small cell lung cancer\u2010cachexia (ROMANA 1) (NCT01387269).2013.http:\/\/clinicaltrials.gov\/ct2\/show\/NCT01387269 2013."},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdu438.62"},{"key":"e_1_2_7_24_1","unstructured":"Clinicaltrials.gov. Safety and efficacy of anamorelin HCI in patients with non\u2010small cell lung cancer\u2010cachexia (ROMANA 2) (NCT01387282).2013.http:\/\/clinicaltrials.gov\/ct\/show\/NCTO01387282 2013."},{"key":"e_1_2_7_25_1","unstructured":"Clinicaltrials.gov. Anamorelin HCl in the treatment of non\u2010small cell lung cancer\u2010cachexia (NSCLC\u2010C): An extension study (ROMANA 3) (NCT01395914).2013.http:\/\/clinicaltrials.gov\/show\/NCT01395914 2013."},{"key":"e_1_2_7_26_1","doi-asserted-by":"crossref","first-page":"TPS9649","DOI":"10.1200\/jco.2013.31.15_suppl.tps9649","article-title":"Phase III clinical trials with anamorelin HCl, a novel oral treatment for NSCLC cachexia","volume":"31","author":"Abernethy AP","year":"2013","journal-title":"J Clin Oncol"},{"key":"e_1_2_7_27_1","doi-asserted-by":"publisher","DOI":"10.1159\/000182528"},{"key":"e_1_2_7_28_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.74.6.1378"},{"key":"e_1_2_7_29_1","doi-asserted-by":"publisher","DOI":"10.1093\/gerona\/56.2.M124"},{"key":"e_1_2_7_30_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.79.4.943"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fcpdd.175","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fcpdd.175","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.175","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.175","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.175","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,6]],"date-time":"2023-10-06T18:17:14Z","timestamp":1696616234000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.175"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,2,9]]},"references-count":29,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2015,3]]}},"alternative-id":["10.1002\/cpdd.175"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.175","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,2,9]]}}}