{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T20:23:40Z","timestamp":1792268620892,"version":"4.4.0"},"reference-count":18,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,2,17]],"date-time":"2025-02-17T00:00:00Z","timestamp":1739750400000},"content-version":"vor","delay-in-days":16,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>This study aimed to evaluate the effects of the concomitant administration of TPN171 and alcohol on hemodynamic and pharmacokinetic characteristics in healthy Chinese male subjects. Fifteen eligible subjects were randomly assigned to one of three sequences, each comprising three treatments: Treatment A (placebo +0.5\u2009g\/kg alcohol), Treatment B (TPN171\u2009+\u20090.5\u2009g\/kg alcohol), and Treatment C (TPN171\u2009+\u2009placebo). Enrolled subjects were administered with 10\u2009mg TPN171 and\/or 0.5\u2009g\/kg alcohol in fasting state in a randomized crossover design. Blood pressure, pulse rate (PR), blood samples, and breath alcohol test were measured at designated time points for hemodynamic and pharmacokinetic analyses. Compared with 10\u2009mg TPN171 alone, administration of 10\u2009mg TPN171\u2009+\u20090.5\u2009g\/kg alcohol significantly lowered the area under the effect\u2013time curve from 0 to 4\u2009h (AUEC<jats:sub>0\u20104h<\/jats:sub>) of systolic blood pressure (95% confidence interval [CI]: \u221229.75 to \u22120.83, <jats:italic>p<\/jats:italic>\u2009=\u20090.039) and significantly increased AUEC<jats:sub>0\u20134h<\/jats:sub> of PR (95% CI: 7.47\u201328.92, <jats:italic>p<\/jats:italic>\u2009=\u20090.003). Compared with 0.5\u2009g\/kg alcohol alone, administration of 10\u2009mg TPN171\u2009+\u20090.5\u2009g\/kg alcohol contributed to significantly higher maximal increase of PR (95% CI: 2.78\u20139.44, <jats:italic>p<\/jats:italic>\u2009=\u20090.002) and AUEC<jats:sub>0\u20104h<\/jats:sub> of PR (95% CI: 1.08\u201324.52, <jats:italic>p<\/jats:italic>\u2009=\u20090.035). Alcohol had no influence on the pharmacokinetics of TPN171, and vice versa. Though the concomitant administration of TPN171 and alcohol induced a more pronounced increase in PR, this did not result in clinical symptoms or heart rate increase\u2010related adverse events, indicating that the combined use was generally safe and well\u2010tolerated.<\/jats:p>","DOI":"10.1111\/cts.70165","type":"journal-article","created":{"date-parts":[[2025,2,17]],"date-time":"2025-02-17T12:38:51Z","timestamp":1739795931000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Hemodynamic and Pharmacokinetic Interactions of TPN171 with Alcohol in Healthy Male Subjects"],"prefix":"10.1111","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-8566-3506","authenticated-orcid":false,"given":"Jie","family":"Cheng","sequence":"first","affiliation":[{"name":"Department of Urology, Zhongshan Hospital Fudan University  Shanghai China"},{"name":"Drug Clinical Trial Center, Shanghai Xuhui Central Hospital\/Xuhui Hospital Fudan University  Shanghai China"},{"name":"Department of Urology, Shanghai Xuhui Central Hospital\/Xuhui Hospital Fudan University  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5209-805X","authenticated-orcid":false,"given":"Hongjie","family":"Qian","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial Center, Shanghai Xuhui Central Hospital\/Xuhui Hospital Fudan University  Shanghai China"},{"name":"Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-7004-349X","authenticated-orcid":false,"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"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2478-9152","authenticated-orcid":false,"given":"Liyu","family":"Liang","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial Center, Shanghai Xuhui Central Hospital\/Xuhui Hospital Fudan University  Shanghai China"},{"name":"Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-0433-4596","authenticated-orcid":false,"given":"Wenjing","family":"Xu","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial Center, Shanghai Xuhui Central Hospital\/Xuhui Hospital Fudan University  Shanghai China"},{"name":"Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-7315-3429","authenticated-orcid":false,"given":"Ye","family":"Liu","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial Center, Shanghai Xuhui Central Hospital\/Xuhui Hospital Fudan University  Shanghai China"},{"name":"Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9834-6912","authenticated-orcid":false,"given":"Qian","family":"Chen","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial Center, Shanghai Xuhui Central Hospital\/Xuhui Hospital Fudan University  Shanghai China"},{"name":"Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6814-0638","authenticated-orcid":false,"given":"Chen","family":"Yu","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial Center, Shanghai Xuhui Central Hospital\/Xuhui Hospital Fudan University  Shanghai China"},{"name":"Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-6626-1508","authenticated-orcid":false,"given":"Huaqing","family":"Duan","sequence":"additional","affiliation":[{"name":"Vigonvita Life Sciences Co., Ltd.  Suzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9450-2260","authenticated-orcid":false,"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"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0849-1196","authenticated-orcid":false,"given":"Hang","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Urology, Zhongshan Hospital Fudan University  Shanghai China"},{"name":"Department of Urology, Shanghai Xuhui Central Hospital\/Xuhui Hospital Fudan University  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2492-3219","authenticated-orcid":false,"given":"Jingying","family":"Jia","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial Center, Shanghai Xuhui Central Hospital\/Xuhui Hospital Fudan University  Shanghai China"},{"name":"Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,2,17]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.jmedchem.9b00123"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S308610"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41401-022-00922-6"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2021.06.007"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.3389\/fendo.2023.1148834"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jsxm.2015.12.034"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1743-6109.2009.01601.x"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.esxm.2019.07.004"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0090-4295(02)01510-8"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0147297"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clpt.2004.07.005"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.5414\/CPP44216"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2009.06.008"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1590\/S0066-782X2010000200004"},{"issue":"3","key":"e_1_2_9_16_1","first-page":"280","article-title":"Acute Alcohol Intoxication: A Clinical Overview","volume":"173","author":"D'Angelo A.","year":"2022","journal-title":"La Clinica Terapeutica"},{"key":"e_1_2_9_17_1","first-page":"135","article-title":"Consensus on the Diagnosis and Treatment of Acute Alcoholic Intoxication","volume":"23","author":"Consensus Expert Group on the Diagnosis and Treatment of Acute Alcoholic Intoxication","year":"2014","journal-title":"Chinese Journal of Emergency Medicine"},{"key":"e_1_2_9_18_1","unstructured":"U.S. Department of Health and Human Services \u201cCommon Terminology Criteria for Adverse Events (CTCAE) v5.0[EB\/OL] \u201d2017 https:\/\/ctep.cancer.gov\/protocoldevelopment\/electronic_applications\/docs\/ctcae_v5_quick_reference_5x7.pdf."},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2020.113634"}],"container-title":["Clinical and Translational Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cts.70165","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T06:04:56Z","timestamp":1760162696000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1111\/cts.70165"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,2]]},"references-count":18,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2025,2]]}},"alternative-id":["10.1111\/cts.70165"],"URL":"https:\/\/doi.org\/10.1111\/cts.70165","archive":["Portico"],"relation":{},"ISSN":["1752-8054","1752-8062"],"issn-type":[{"value":"1752-8054","type":"print"},{"value":"1752-8062","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,2]]},"assertion":[{"value":"2024-08-14","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-02-05","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-02-17","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70165"}}