{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,15]],"date-time":"2025-10-15T17:48:05Z","timestamp":1760550485907},"reference-count":16,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2018,2,14]],"date-time":"2018-02-14T00:00:00Z","timestamp":1518566400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100004334","name":"Merck","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004334","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2018,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Odanacatib (ODN), an oral selective inhibitor of cathepsin K, was an investigational agent previously in development for the treatment of osteoporosis. In this phase 1 open\u2010label study, 12 healthy Chinese postmenopausal women received single\u2010dose ODN 50\u00a0mg on day\u00a01 and multiple\u2010dose ODN 50\u00a0mg once weekly on days 15, 22, 29, and 36 under fasted conditions. Pharmacokinetic (PK) parameters were evaluated on days 1 and 36. Multiple\u2010dose area under the concentration\u2013time profile (AUC<jats:sub>0\u2013168h<\/jats:sub>) and maximum plasma concentration (C<jats:sub>max<\/jats:sub>) were compared with historical data from 9 non\u2010Chinese postmenopausal women who also received ODN 50 mg once weekly for 4\u00a0weeks. Median time to C<jats:sub>max<\/jats:sub> (t<jats:sub>max<\/jats:sub>) was 3 and 4\u00a0hours following single\u2010 and multiple\u2010dose administration, respectively. The arithmetic mean \u00b1 SD terminal half\u2010life was 81.0 \u00b1 14.0 and 106.7 \u00b1 14.4 hours following single\u2010 and multiple\u2010dose administration, respectively. Comparison of multiple\u2010dose PK parameters showed that the geometric mean ratios (Chinese\/non\u2010Chinese) and 95%CIs for AUC<jats:sub>0\u2013168h<\/jats:sub> and C<jats:sub>max<\/jats:sub> were 0.81 (0.55\u20121.19) and 0.87 (0.69\u20121.11), respectively. All adverse events were mild, none were serious, and none led to discontinuation. Single\u2010 and multiple\u2010dose PKs of ODN 50 mg in Chinese postmenopausal women were generally similar to those previously reported in non\u2010Chinese postmenopausal women.<\/jats:p>","DOI":"10.1002\/cpdd.434","type":"journal-article","created":{"date-parts":[[2018,2,14]],"date-time":"2018-02-14T16:04:57Z","timestamp":1518624297000},"page":"744-750","source":"Crossref","is-referenced-by-count":4,"title":["Odanacatib Pharmacokinetics Comparison Between Chinese and Non\u2010Chinese Postmenopausal Women"],"prefix":"10.1002","volume":"7","author":[{"given":"Xia","family":"Chen","sequence":"first","affiliation":[{"name":"Peking Union Medical College Hospital Clinical Pharmacological Research Center  Beijing China"},{"name":"Beijing Key Laboratory of Clinical PK and PD Investigation for Innovative Drugs  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ji","family":"Jiang","sequence":"additional","affiliation":[{"name":"Peking Union Medical College Hospital Clinical Pharmacological Research Center  Beijing China"},{"name":"Beijing Key Laboratory of Clinical PK and PD Investigation for Innovative Drugs  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pei","family":"Hu","sequence":"additional","affiliation":[{"name":"Peking Union Medical College Hospital Clinical Pharmacological Research Center  Beijing China"},{"name":"Beijing Key Laboratory of Clinical PK and PD Investigation for Innovative Drugs  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefan","family":"Zajic","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc.\u200a\u200a\u200a\u200a  Kenilworth NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wen","family":"Liu","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc.\u200a\u200a\u200a\u200a  Kenilworth NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jacqueline","family":"McCrea","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc.\u200a\u200a\u200a\u200a  Kenilworth NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fang","family":"Liu","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc.\u200a\u200a\u200a\u200a  Kenilworth NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rose","family":"Witter","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc.\u200a\u200a\u200a\u200a  Kenilworth NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eric","family":"Mangin","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc.\u200a\u200a\u200a\u200a  Kenilworth NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S. Aubrey","family":"Stoch","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc.\u200a\u200a\u200a\u200a  Kenilworth NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,2,14]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1359\/jbmr.091035"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/jbmr.212"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/jbmr.1695"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00198-013-2398-2"},{"issue":"10","key":"e_1_2_8_6_1","doi-asserted-by":"crossref","first-page":"669","DOI":"10.1038\/nrd.2016.207","article-title":"Merck &Co. drops osteoporosis drug odanacatib","volume":"15","author":"Mullard A","year":"2016","journal-title":"Nat Rev Drug Discov."},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.116.069906"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2012.04471.x"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2013-1688"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2009.60"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.110.037184"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.113.056580"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jchromb.2011.12.004"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.2217\/14622416.6.7.731"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2012-2972"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2013-2020"},{"key":"e_1_2_8_17_1","article-title":"Odanacatib anti\u2010fracture efficacy and safety in postmenopausal women with osteoporosis: results from the phase III Long\u2010Term Odanacatib Fracture Trial (LOFT) [abstract].","author":"McClung MR","year":"2015","journal-title":"IBMS BoneKEy"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fcpdd.434","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.434","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,9]],"date-time":"2023-09-09T13:18:34Z","timestamp":1694265514000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.434"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,2,14]]},"references-count":16,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2018,9]]}},"alternative-id":["10.1002\/cpdd.434"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.434","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,2,14]]}}}