{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:24:36Z","timestamp":1792787076505,"version":"4.5.0"},"reference-count":10,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2019,11,6]],"date-time":"2019-11-06T00:00:00Z","timestamp":1572998400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Kyorin Pharmaceutical Co., Ltd."}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["LUTS"],"published-print":{"date-parts":[[2020,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This was a single\u2010institution, single\u2010dose, single\u2010arm phase 1 study in healthy adult males to evaluate the safety and absorption of dimethyl sulfoxide (DMSO) from the bladder into the body when KRP\u2010116D (a 50% w\/w DMSO solution) was intravesically administered and allowed to remain in the bladder for 15\u2009minutes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Six healthy adult males were enrolled in this study. KRP\u2010116D (50\u2009mL) was instilled directly into the bladder via a catheter where it was allowed to remain for 15\u2009minutes under lidocaine anesthesia in accordance with the usage of RIMSO\u201050 (50% w\/w DMSO solution) approved in the USA. The residual DMSO solution in the bladder was collected 15\u2009minutes after instillation. The concentrations of DMSO in the plasma and the recovered solution were analyzed by a validated high\u2010performance liquid chromatography (HPLC) method. The concentration in the residual DMSO solution was multiplied by the solution volume and divided by the dosage to calculate the recovery rate of DMSO.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Plasma DMSO was detected in one of six subjects, and in the remaining five subjects DMSO was not detected (&lt;19.6\u2009\u03bcg\/mL). The recovery rate of DMSO from the bladder was 60.7% to 93.7%. The only drug\u2010related adverse event was breath odor (garlic\u2010like breath) observed in four of six subjects (66.7%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Absorption of DMSO from the bladder was low (16.3%), and the systemic exposure was limited. Most of the DMSO was recovered from the bladder. KRP\u2010116D 50\u2009mL was well tolerated and safe.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/luts.12295","type":"journal-article","created":{"date-parts":[[2019,11,6]],"date-time":"2019-11-06T22:33:10Z","timestamp":1573079590000},"page":"150-154","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Phase I study of KRP\u2010116D, a 50% w\/w dimethyl sulfoxide aqueous solution, on the systemic absorption from bladder by intravesical instillation in healthy Japanese subjects"],"prefix":"10.1111","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4974-2369","authenticated-orcid":false,"given":"Hideyo","family":"Shimada","sequence":"first","affiliation":[{"name":"Department of internal medicine Shimada Medical Clinic  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Makoto","family":"Yono","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology Nishi Kumamoto Hospital, Souseikai  Kumamoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuya","family":"Hojo","sequence":"additional","affiliation":[{"name":"Department of DMPK Research Laboratory Kyorin Pharmaceutical Co., Ltd.  Tochigi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuka","family":"Hamamura","sequence":"additional","affiliation":[{"name":"Department of Clinical Development Kyorin Pharmaceutical Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atsushi","family":"Ootsuki","sequence":"additional","affiliation":[{"name":"Department of Clinical Development Kyorin Pharmaceutical Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,11,6]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1442-2042.2008.02208.x"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2011.03.064"},{"key":"e_1_2_8_4_1","first-page":"25","article-title":"Pathology and terminology of interstitial cystitis\/bladder pain syndrome: a review","volume":"34","author":"Akiyama Y","year":"2019","journal-title":"Histol Histopathol"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.20638"},{"key":"e_1_2_8_6_1","first-page":"486","article-title":"A survey on clinical practice of interstitial cystitis in Japan","volume":"4","author":"Yamada Y","year":"2015","journal-title":"Transl Androl Urol"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-5347(05)67376-4"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/0011-2240(86)90014-3"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.urology.2006.08.1105"},{"key":"e_1_2_8_10_1","unstructured":"US National Library of Medicine. RIMSO\u201050\u2010 dimethyl sulfoxide irrigant.https:\/\/dailymed.nlm.nih.gov\/dailymed\/drugInfo.cfm?setid=58b25d79-78f2-4953-b0c6-61658dc4ef0d. Accessed March 21 2019."},{"key":"e_1_2_8_11_1","first-page":"309","article-title":"Studies on the absorption, excretion, and metabolism of dimethylsulfoxide (DMSO) in man","volume":"155","author":"Hucker HB","year":"1967","journal-title":"J Pharmacol Exp Ther"}],"container-title":["LUTS: Lower Urinary Tract Symptoms"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fluts.12295","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/luts.12295","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/luts.12295","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/luts.12295","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,6]],"date-time":"2023-09-06T14:03:36Z","timestamp":1694009016000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/luts.12295"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,11,6]]},"references-count":10,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2020,5]]}},"alternative-id":["10.1111\/luts.12295"],"URL":"https:\/\/doi.org\/10.1111\/luts.12295","archive":["Portico"],"relation":{"has-review":[{"id-type":"doi","id":"10.3410\/f.741443534.793591007","asserted-by":"object"}]},"ISSN":["1757-5664","1757-5672"],"issn-type":[{"value":"1757-5664","type":"print"},{"value":"1757-5672","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,11,6]]},"assertion":[{"value":"2019-06-18","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-10-03","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-11-06","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}