{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,19]],"date-time":"2026-07-19T15:28:13Z","timestamp":1784474893431,"version":"3.55.0"},"reference-count":22,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2025,4,25]],"date-time":"2025-04-25T00:00:00Z","timestamp":1745539200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>TPN171 is a phosphodiesterase\u20105 inhibitor. It is currently being developed in China to treat pulmonary arterial hypertension and erectile dysfunction (ED). This study aimed to compare the pharmacokinetics and safety of TPN171 across participants with normal hepatic function and hepatic impairment (HI). An open\u2010label, single\u2010dose, parallel\u2010group study enrolled participants with normal hepatic function (group C) and mild\u2010to\u2010moderate HI (groups A and B). In each cohort, 8 participants completed the study. Blood samples were collected up to 72\u00a0hours after 10\u00a0mg oral TPN171 administration. The maximum plasma concentration (C<jats:sub>max<\/jats:sub>), area under the plasma concentration\u2013time curve from time zero to the last quantifiable concentration (AUC<jats:sub>0\u2010t<\/jats:sub>), and AUC extrapolated to infinite time (AUC<jats:sub>0\u2010\u221e<\/jats:sub>) were compared between the groups. C<jats:sub>max<\/jats:sub>, AUC<jats:sub>0\u2010t<\/jats:sub>, and AUC<jats:sub>0\u2010\u221e<\/jats:sub> were higher in groups A and B than in group C (geometric mean ratios 1.17\u20101.20, 1.46\u20101.53, and 1.45\u20101.54, respectively), while the elimination half\u2010time was prolonged and clearance was reduced in the HI groups. All adverse events were not serious and no participant withdrew from this study. Considering the increase in TPN171 plasma exposure, the highest dose of 5\u00a0mg TPN171 is recommended in patients with ED having mild\u2010to\u2010moderate HI.<\/jats:p>","DOI":"10.1002\/cpdd.1535","type":"journal-article","created":{"date-parts":[[2025,4,25]],"date-time":"2025-04-25T12:55:32Z","timestamp":1745585732000},"page":"472-478","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Pharmacokinetics and Safety of TPN171 (a PDE5 Inhibitor) in Patients With Mild or Moderate Hepatic Impairment Versus Participants With Normal Hepatic Function: A Phase 1 Study"],"prefix":"10.1002","volume":"14","author":[{"given":"Jing","family":"Zhou","sequence":"first","affiliation":[{"name":"Phase I Clinical Research Center The First Hospital of Jilin University  Jilin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hong","family":"Zhang","sequence":"additional","affiliation":[{"name":"Phase I Clinical Research Center The First Hospital of Jilin University  Jilin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanhua","family":"Ding","sequence":"additional","affiliation":[{"name":"Phase I Clinical Research Center The First Hospital of Jilin University  Jilin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhen","family":"Wang","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Drug Research Shanghai Institute of Materia Medica Chinese Academy of Sciences  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu","family":"Wang","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Drug Research Shanghai Institute of Materia Medica Chinese Academy of Sciences  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiaxiang","family":"Juan","sequence":"additional","affiliation":[{"name":"Clinical Development Department Vigonvita Life Sciences Co., Ltd.  Suzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhicheng","family":"Jiang","sequence":"additional","affiliation":[{"name":"Clinical Development Department Vigonvita Life Sciences Co., Ltd.  Suzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hong","family":"Chen","sequence":"additional","affiliation":[{"name":"Phase I Clinical Research Center The First Hospital of Jilin University  Jilin China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,4,25]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.biopha.2020.111128"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/bph.14205"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1146\/annurev-pharmtox-040122-034745"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrdp.2016.3"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pharmthera.2020.107493"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrcardio.2017.84"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.jmedchem.0c01093"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1742-1241.2006.01049.x"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/andr.12683"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-199957060-00015"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.0306-5251.2001.00029.x"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2006.02726.x"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.sxmr.2017.08.001"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1080\/17512433.2016.1212655"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1177\/1060028013501989"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bmcl.2009.03.125"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1021\/jm301159y"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bmcl.2013.06.062"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.jmedchem.9b00123"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41401-022-00922-6"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2019.05.001"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S308610"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1535","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,6,3]],"date-time":"2025-06-03T03:34:53Z","timestamp":1748921693000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.1535"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,4,25]]},"references-count":22,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2025,6]]}},"alternative-id":["10.1002\/cpdd.1535"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.1535","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,4,25]]},"assertion":[{"value":"2025-01-13","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-03-10","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-04-25","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}