Pharmacokinetics and Safety of Imeglimin in Japanese Patients With Impaired Renal Function
Imeglimin is a diabetic drug excreted mainly in the urine; therefore, the impact of renal impairment on its pharmacokinetics (PK) is of interest. We assessed the PK and safety of imeglimin in Japanese patients with impaired renal function. This was an uncontrolled, open‐label, single‐dose, phase 1 s...
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| Veröffentlicht in: | Journal of clinical pharmacology 2023-07, Vol.63 (7), p.807-816 |
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| creator | Kitamura, Atsushi Yumizaki, Takuya Kondo, Tomoe Sekino, Hisakuni Kakuyama, Hiroyoshi |
| description | Imeglimin is a diabetic drug excreted mainly in the urine; therefore, the impact of renal impairment on its pharmacokinetics (PK) is of interest. We assessed the PK and safety of imeglimin in Japanese patients with impaired renal function. This was an uncontrolled, open‐label, single‐dose, phase 1 study. Participants were classified into 4 groups by their estimated glomerular filtration rate (mL/min/1.73 m2) as follows: ≥90, normal renal function; and 60 to |
| doi_str_mv | 10.1002/jcph.2218 |
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We assessed the PK and safety of imeglimin in Japanese patients with impaired renal function. This was an uncontrolled, open‐label, single‐dose, phase 1 study. Participants were classified into 4 groups by their estimated glomerular filtration rate (mL/min/1.73 m2) as follows: ≥90, normal renal function; and 60 to <90, mild; 30 to <60, moderate; and 15 to <30, severe renal impairment. All participants received imeglimin 1000 mg except those with severe renal impairment, who received imeglimin 500 mg. PK parameters were estimated using noncompartmental analysis, and those after multiple administrations were projected using a noncompartmental superposition method. In total, 24 Japanese participants (6 in each group) were enrolled and completed the study. The mean plasma imeglimin concentration reached the maximum at 2‐4 hours after administration and then rapidly decreased. The geometric mean maximum observed plasma concentration and area under the plasma concentration–time curve values were higher in the impaired renal function groups versus normal renal function group. Most imeglimin was excreted in urine by 24 hours after administration. Renal clearance decreased with decreasing renal function. Projected maximum observed plasma concentration and area under the plasma concentration–time curve over the dosing interval after multiple dosing were greater in the renal impairment groups versus normal renal function group. No adverse events were observed. Considering increased plasma exposure along with decreased renal clearance, dose adjustment is required in patients with moderate and severe renal impairment with estimated glomerular filtration rate of 15 to <45 mL/min/1.73 m2.</description><identifier>ISSN: 0091-2700</identifier><identifier>EISSN: 1552-4604</identifier><identifier>DOI: 10.1002/jcph.2218</identifier><identifier>PMID: 36847203</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Diabetes mellitus ; Dosage ; Glomerular filtration rate ; imeglimin ; Japanese ; Pharmacokinetics ; Plasma ; Renal function ; renal impairment</subject><ispartof>Journal of clinical pharmacology, 2023-07, Vol.63 (7), p.807-816</ispartof><rights>2023 The Authors. The published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology.</rights><rights>2023 The Authors. The Journal of Clinical Pharmacology published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology.</rights><rights>2023. This article is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3888-7e0bb6ce461691bfaebc92227173e03659a719e01041b324e29337ea242151833</citedby><cites>FETCH-LOGICAL-c3888-7e0bb6ce461691bfaebc92227173e03659a719e01041b324e29337ea242151833</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fjcph.2218$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fjcph.2218$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36847203$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kitamura, Atsushi</creatorcontrib><creatorcontrib>Yumizaki, Takuya</creatorcontrib><creatorcontrib>Kondo, Tomoe</creatorcontrib><creatorcontrib>Sekino, Hisakuni</creatorcontrib><creatorcontrib>Kakuyama, Hiroyoshi</creatorcontrib><title>Pharmacokinetics and Safety of Imeglimin in Japanese Patients With Impaired Renal Function</title><title>Journal of clinical pharmacology</title><addtitle>J Clin Pharmacol</addtitle><description>Imeglimin is a diabetic drug excreted mainly in the urine; therefore, the impact of renal impairment on its pharmacokinetics (PK) is of interest. We assessed the PK and safety of imeglimin in Japanese patients with impaired renal function. This was an uncontrolled, open‐label, single‐dose, phase 1 study. Participants were classified into 4 groups by their estimated glomerular filtration rate (mL/min/1.73 m2) as follows: ≥90, normal renal function; and 60 to <90, mild; 30 to <60, moderate; and 15 to <30, severe renal impairment. All participants received imeglimin 1000 mg except those with severe renal impairment, who received imeglimin 500 mg. PK parameters were estimated using noncompartmental analysis, and those after multiple administrations were projected using a noncompartmental superposition method. In total, 24 Japanese participants (6 in each group) were enrolled and completed the study. The mean plasma imeglimin concentration reached the maximum at 2‐4 hours after administration and then rapidly decreased. The geometric mean maximum observed plasma concentration and area under the plasma concentration–time curve values were higher in the impaired renal function groups versus normal renal function group. Most imeglimin was excreted in urine by 24 hours after administration. Renal clearance decreased with decreasing renal function. Projected maximum observed plasma concentration and area under the plasma concentration–time curve over the dosing interval after multiple dosing were greater in the renal impairment groups versus normal renal function group. No adverse events were observed. Considering increased plasma exposure along with decreased renal clearance, dose adjustment is required in patients with moderate and severe renal impairment with estimated glomerular filtration rate of 15 to <45 mL/min/1.73 m2.</description><subject>Diabetes mellitus</subject><subject>Dosage</subject><subject>Glomerular filtration rate</subject><subject>imeglimin</subject><subject>Japanese</subject><subject>Pharmacokinetics</subject><subject>Plasma</subject><subject>Renal function</subject><subject>renal impairment</subject><issn>0091-2700</issn><issn>1552-4604</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><recordid>eNp10F9rFDEUBfAgil1rH_wCEvBFH6a9N8kkmUdZrG0pdGkVoS9DJnvHzTr_nMxQ9tubdVsfhMKF-_LjcDiMvUM4RQBxtvXD5lQItC_YAvNcZEqDeskWAAVmwgAcsTcxbgFQqxxfsyOprTIC5ILdrzZubJ3vf4WOpuAjd92a37maph3va37Z0s8mtKHj6a7c4DqKxFduCtRNkf8I0yaZwYWR1vyWOtfw87nzU-i7t-xV7ZpIJ4__mH0___JteZFd33y9XH6-zry01maGoKq0J6VRF1jVjipfCCEMGkkgdV44gwUBgsJKCkWikNKQE0pgjlbKY_bxkDuM_e-Z4lS2IXpqmtS1n2MpjAWVnLaJfviPbvt5TKWTsiLH1MHopD4dlB_7GEeqy2EMrRt3JUK5H7zcD17uB0_2_WPiXLW0_iefFk7g7AAeQkO755PKq-Xq4m_kH3wQiDs</recordid><startdate>202307</startdate><enddate>202307</enddate><creator>Kitamura, Atsushi</creator><creator>Yumizaki, Takuya</creator><creator>Kondo, Tomoe</creator><creator>Sekino, Hisakuni</creator><creator>Kakuyama, Hiroyoshi</creator><general>Wiley Subscription Services, Inc</general><scope>24P</scope><scope>WIN</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope><scope>7QR</scope><scope>7T5</scope><scope>7TK</scope><scope>7TM</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope></search><sort><creationdate>202307</creationdate><title>Pharmacokinetics and Safety of Imeglimin in Japanese Patients With Impaired Renal Function</title><author>Kitamura, Atsushi ; Yumizaki, Takuya ; Kondo, Tomoe ; Sekino, Hisakuni ; Kakuyama, Hiroyoshi</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3888-7e0bb6ce461691bfaebc92227173e03659a719e01041b324e29337ea242151833</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Diabetes mellitus</topic><topic>Dosage</topic><topic>Glomerular filtration rate</topic><topic>imeglimin</topic><topic>Japanese</topic><topic>Pharmacokinetics</topic><topic>Plasma</topic><topic>Renal function</topic><topic>renal impairment</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kitamura, Atsushi</creatorcontrib><creatorcontrib>Yumizaki, Takuya</creatorcontrib><creatorcontrib>Kondo, Tomoe</creatorcontrib><creatorcontrib>Sekino, Hisakuni</creatorcontrib><creatorcontrib>Kakuyama, Hiroyoshi</creatorcontrib><collection>Wiley Online Library (Open Access Collection)</collection><collection>Wiley Online Library (Open Access Collection)</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Chemoreception Abstracts</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of clinical pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kitamura, Atsushi</au><au>Yumizaki, Takuya</au><au>Kondo, Tomoe</au><au>Sekino, Hisakuni</au><au>Kakuyama, Hiroyoshi</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pharmacokinetics and Safety of Imeglimin in Japanese Patients With Impaired Renal Function</atitle><jtitle>Journal of clinical pharmacology</jtitle><addtitle>J Clin Pharmacol</addtitle><date>2023-07</date><risdate>2023</risdate><volume>63</volume><issue>7</issue><spage>807</spage><epage>816</epage><pages>807-816</pages><issn>0091-2700</issn><eissn>1552-4604</eissn><abstract>Imeglimin is a diabetic drug excreted mainly in the urine; therefore, the impact of renal impairment on its pharmacokinetics (PK) is of interest. We assessed the PK and safety of imeglimin in Japanese patients with impaired renal function. This was an uncontrolled, open‐label, single‐dose, phase 1 study. Participants were classified into 4 groups by their estimated glomerular filtration rate (mL/min/1.73 m2) as follows: ≥90, normal renal function; and 60 to <90, mild; 30 to <60, moderate; and 15 to <30, severe renal impairment. All participants received imeglimin 1000 mg except those with severe renal impairment, who received imeglimin 500 mg. PK parameters were estimated using noncompartmental analysis, and those after multiple administrations were projected using a noncompartmental superposition method. In total, 24 Japanese participants (6 in each group) were enrolled and completed the study. The mean plasma imeglimin concentration reached the maximum at 2‐4 hours after administration and then rapidly decreased. The geometric mean maximum observed plasma concentration and area under the plasma concentration–time curve values were higher in the impaired renal function groups versus normal renal function group. Most imeglimin was excreted in urine by 24 hours after administration. Renal clearance decreased with decreasing renal function. Projected maximum observed plasma concentration and area under the plasma concentration–time curve over the dosing interval after multiple dosing were greater in the renal impairment groups versus normal renal function group. No adverse events were observed. Considering increased plasma exposure along with decreased renal clearance, dose adjustment is required in patients with moderate and severe renal impairment with estimated glomerular filtration rate of 15 to <45 mL/min/1.73 m2.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>36847203</pmid><doi>10.1002/jcph.2218</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Diabetes mellitus Dosage Glomerular filtration rate imeglimin Japanese Pharmacokinetics Plasma Renal function renal impairment |
| title | Pharmacokinetics and Safety of Imeglimin in Japanese Patients With Impaired Renal Function |
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