{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Burkard U"],"funding":["Boehringer Ingelheim International GmbH"],"pagination":["87-99"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC8901509"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["42(1)"],"pubmed_abstract":["BACKGROUND AND OBJECTIVES: BI 425809, a novel glycine transporter-1 inhibitor, may ameliorate cognitive deficits in schizophrenia. The objectives of the studies were: to assess absolute bioavailability of oral BI 425809 compared with intravenous (IV) microtracer infusion (study 1), and to determine the mass balance, distribution, metabolism, and excretion of BI 425809 (study 2).<h4>Methods</h4>These were Phase I, open-label, non-randomized, single-period, single-arm studies in healthy males. Study 1 administered a single oral dose of unlabeled BI 425809 25 mg, then an IV microtracer infusion of [<sup>14</sup>C]-BI 425809 30 µg. In study 2, participants received an oral dose of [<sup>14</sup>C]-BI 425809 25 mg containing [<sup>14</sup>C]-labeled (dose: 3.7 megabecquerel (0.41 mSv)) and unla"],"journal":["Clinical drug investigation"],"pubmed_title":["The Absolute Bioavailability, Absorption, Distribution, Metabolism, and Excretion of BI 425809 Administered as an Oral Dose or an Oral Dose with an Intravenous Microtracer Dose of [<sup>14</sup>C]-BI 425809 in Healthy Males."],"pmcid":["PMC8901509"],"funding_grant_id":["1346-0016","Study numbers 1346-0015"],"pubmed_authors":["Desch M","Teitelbaum AM","Shatillo Y","Wunderlich G","Schlecker C","Liu P","Mack SR","Burkard U","Chan TS"],"additional_accession":[]},"is_claimable":false,"name":"The Absolute Bioavailability, Absorption, Distribution, Metabolism, and Excretion of BI 425809 Administered as an Oral Dose or an Oral Dose with an Intravenous Microtracer Dose of [<sup>14</sup>C]-BI 425809 in Healthy Males.","description":"BACKGROUND AND OBJECTIVES: BI 425809, a novel glycine transporter-1 inhibitor, may ameliorate cognitive deficits in schizophrenia. The objectives of the studies were: to assess absolute bioavailability of oral BI 425809 compared with intravenous (IV) microtracer infusion (study 1), and to determine the mass balance, distribution, metabolism, and excretion of BI 425809 (study 2).<h4>Methods</h4>These were Phase I, open-label, non-randomized, single-period, single-arm studies in healthy males. Study 1 administered a single oral dose of unlabeled BI 425809 25 mg, then an IV microtracer infusion of [<sup>14</sup>C]-BI 425809 30 µg. In study 2, participants received an oral dose of [<sup>14</sup>C]-BI 425809 25 mg containing [<sup>14</sup>C]-labeled (dose: 3.7 megabecquerel (0.41 mSv)) and unla","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Jan","modification":"2026-05-09T03:22:37.276Z","creation":"2025-02-19T03:46:49.156Z"},"accession":"S-EPMC8901509","cross_references":{"pubmed":["34936055"],"doi":["10.1007/s40261-021-01111-9"]}}