Author(s): Patricia N. Sidharta*, Hartmut Fischer and Jasper Dingemanse
Page: [399 - 410] Pages: 12
* (Excluding Mailing and Handling)
Background: Aprocitentan is an orally active, dual endothelin receptor antagonist that may offer a new therapeutic option for the treatment of difficult-to-control hypertension.
Objective: To investigate safety, tolerability, mass balance, absorption, distribution, metabolism, and excretion of aprocitentan.
Methods: In this single-center, open-label study, a single oral dose of 25 mg containing 3.7 MBq of 14C-radiolabeled aprocitentan was administered to 6 healthy male subjects. Metabolites were identified using mass spectrometry and, where possible, confirmed and quantified with reference compounds.
Results: Aprocitentan was well tolerated and there were no clinically significant findings for any safety variable. The geometric mean cumulative recovery of radioactivity from urine and feces over 14 days was 77% of the administered radioactive dose, with 52.1% cumulative recovery from urine and 24.8% from feces. Concentrations of total radioactivity in whole blood were markedly lower compared to plasma. In plasma, 94.3% of total radioactivity was aprocitentan. In urine and feces, 5 and 2, respectively (in feces one being aprocitentan) main products were identified. Metabolism data of aprocitentan identified two main elimination pathways, glucosidation to M3 and hydrolysis to M1, representing approximately 25% and 32% of the radioactive dose, respectively.
Conclusions: Based on these metabolism data, aprocitentan can be concomitantly administered without dose adjustment with drugs that are inhibitors or inducers of any metabolizing enzyme, specifically cytochrome P450 enzymes.
Keywords: Aprocitentan, endothelin receptor antagonist, absorption, distribution, metabolism, excretion.
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CASE j.track WHEN 0 THEN false ELSE true END as tracksAccessByVolume,"article" as access_level, j.issue_id, j.article_id from `user_access_article_token` as `j` inner join `user_access_info` as `info` on `j`.`user_access_id` = `info`.`user_access_id` where ((j.from_ip <= 58835923 and j.to_ip >=58835923 )) and ((j.from_date <= 1737187347 and j.to_date >= 1737187347 and j.perpetual= 0) or (j.from_date is null and j.to_date is null and j.perpetual= 1)) and j.article_id = 113994)
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select * from `article` where `first_page` < '399' and is_uploaded = 1 and issue_id = 10717 order by cast(first_page as SIGNED) desc limit 1
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select * from `article` where `last_page` > '410' and is_uploaded = 1 and issue_id = 10717 order by cast(first_page as SIGNED) asc limit 1
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select `language_id` from `multilanguage` where `short_code` = 'en'
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select `source_lang_label`, `target_lang_label` from `multilanguage_labels` where `target_lang_id` = 1
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select `id` from `multilanguage_article` where `article_id` = 113994 limit 1
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select b.banner_link, b.banner_name, b.banner_script, b.banner_remarks, b.banner_file_name, b.banner_placement, bd.content_type, bd.content_id from `tbl_banner` as `b` inner join `tbl_banner_detail` as `bd` on `bd`.`banner_id` = `b`.`banner_id` inner join `users` as `u` on `u`.`id` = `b`.`updated_by` inner join `journal` as `j` on `j`.`journal_id` = `bd`.`content_id` where `b`.`banner_journal` = 1 and `bd`.`content_type` = 'J' and `bd`.`content_id` = 15 and `b`.`banner_from_date` <= 1737187347 and `b`.`banner_to_date` >= 1737187347 and `b`.`banner_status` = 'A' order by `b`.`banner_id` desc
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select count(*) as aggregate from `uc_cart_products` where cart_id='5b94e9f41a16191cd276169619af116c'
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200
[]
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