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Safety, pharmacokinetics, and food effect of sudapyridine (WX‐081), a novel anti‐tuberculosis candidate in healthy Chinese subjects

التفاصيل البيبلوغرافية
العنوان: Safety, pharmacokinetics, and food effect of sudapyridine (WX‐081), a novel anti‐tuberculosis candidate in healthy Chinese subjects
المؤلفون: Chengyin Yu, Hongjie Qian, Qingqing Wu, Yang Zou, Qicheng Ding, Yuting Cai, Liyu Liang, Juncai Xu, Lei Li, Bin Zan, Yongguo Li, Yun Liu
المصدر: Clinical and Translational Science, Vol 17, Iss 2, Pp n/a-n/a (2024)
بيانات النشر: Wiley, 2024.
سنة النشر: 2024
المجموعة: LCC:Therapeutics. Pharmacology
LCC:Public aspects of medicine
مصطلحات موضوعية: Therapeutics. Pharmacology, RM1-950, Public aspects of medicine, RA1-1270
الوصف: Abstract This study aimed to assess the safety, pharmacokinetics, and food impact on sudapyridine (WX‐081), a novel drug designed to inhibit mycobacterium ATP synthase, with clinical applications for drug‐resistant tuberculosis (TB) treatment. The research comprised two arms: a single ascending dose (SAD) arm (30 to 600 mg, N = 52) and a multiple ascending dose (MAD) arm (200 to 400 mg, N = 30). The influence of food was evaluated using a 400 mg dose within an SAD cohort. Plasma concentrations of WX‐081 and M3 (main metabolite of WX‐081) were analyzed using a validated liquid‐chromatography tandem mass spectrometry method. In the SAD arm, mean residence time (MRT0‐t), terminal half‐life, and clearance of WX‐081 ranged from 18.87 to 52.8 h, 31.39 to 236.57 h, and 6.4 to 80.34 L/h, respectively. The area under the curve from time zero to the last measurable timepoint (AUC0‐t) of WX‐081 showed dose‐proportional increases in the SAD arm. The disparity between fasted and fed states of WX‐081 was significant (p
نوع الوثيقة: article
وصف الملف: electronic resource
اللغة: English
تدمد: 1752-8062
1752-8054
Relation: https://doaj.org/toc/1752-8054; https://doaj.org/toc/1752-8062
DOI: 10.1111/cts.13718
URL الوصول: https://doaj.org/article/3ef73d703b9444ae8e3596ff07624e4a
رقم الأكسشن: edsdoj.3ef73d703b9444ae8e3596ff07624e4a
قاعدة البيانات: Directory of Open Access Journals
الوصف
تدمد:17528062
17528054
DOI:10.1111/cts.13718