A Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeated doses of ART-648/TAK-648 in healthy Japanese volunteers - Phase 1 study of ART-648/TAK-648

开始日期2018-12-03

申办/合作机构-

NCT02480439 / Completed临床1期

A Phase 1, Randomized, Open-Label, Single-Dose, 3-Way Crossover Study to Assess the Relative Bioavailability of a TAK-648 Tablet Compared With a TAK-648 Oral Solution, and to Assess the Effect of Food on the Bioavailability of a TAK-648 Tablet in Healthy Participants

The purpose of this study is to assess the relative bioavailability of a TAK-648 tablet compared with a TAK-648 oral solution, and to assess the effect of food on the bioavailability of a TAK-648 tablet in healthy participants.

开始日期2015-06-01

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

100 项与 TAK-648 相关的临床结果

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100 项与 TAK-648 相关的转化医学

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100 项与 TAK-648 相关的专利（医药）

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项与 TAK-648 相关的文献（医药）

2017-05-01·Clinical and Translational Science

Pharmacokinetic/Pharmacodynamic Modeling of the PDE4 Inhibitor TAK‐648 in Type 2 Diabetes: Early Translational Approaches for Human Dose Prediction

Article

作者: Hanauer, G ; Vollert, S ; Lahu, G ; Plock, N ; Mayer, M

TAK‐648 is a PDE4 inhibitor with demonstrated preclinical antidiabetic properties. Our objective was to develop a translational pharmacokinetic/pharmacodynamic (PK/PD) model for human type 2 diabetes (T2D) dose prediction using HbA1c results from a db/db mouse study. Estimated parameters in combination with tPDE4i values calculated for the clinical roflumilast dose of 500 μg were used to translate preclinical effects of TAK‐648 to required exposure in humans. A first‐in‐human study with single TAK‐648 doses of 0.05–0.85 mg in healthy volunteers yielded mean maximum TAK‐648 concentrations (Cmax) and area under the curve (AUC) values from 0.62–11.9 μg/L and 4.58–93.8 μg*h/L, respectively. Based on the performed pharmacokinetic/pharmacodynamic analysis and clinical PK results, clinical efficacy would be expected at a daily dose of 0.1 mg, which is well within the investigated clinical dose range. This result significantly enhanced the confidence in TAK‐648 for type 2 diabetes treatment and underlines the necessity of translational approaches in early preclinical phases.

100 项与 TAK-648 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
非酒精性脂肪性肝炎	临床1期	-	Takeda Pharmaceutical Co., Ltd.	-
非酒精性脂肪性肝炎	临床1期	-	ARTham Therapeutics, Inc.初创企业	-
2型糖尿病	药物发现	美国	Takeda Pharmaceutical Co., Ltd.	2015-04-01
糖尿病肾病	药物发现	美国	Takeda Pharmaceutical Co., Ltd.	-

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02430870 (CTgov)	临床1期	2型糖尿病	48	TAK-648 (Part 1 Cohort 1: TAK-648 0.35 mg)	範願繭鹹餘窪遞築淵齋(衊選窪壓願觸憲壓願鬱) = 夢廠淵窪築鹹築顧網範積廠艱艱淵簾淵蓋製鬱 (衊構淵顧築鏇鬱網蓋醖, 積鏇鹹蓋獵願鏇範構鬱 ~ 構範夢蓋餘構願範繭繭) 更多	-	2016-08-31
				TAK-648 (Part 1 Cohort 2: TAK-648 0.80 mg)	範願繭鹹餘窪遞築淵齋(衊選窪壓願觸憲壓願鬱) = 膚餘構夢襯艱鹽構鬱蓋積廠艱艱淵簾淵蓋製鬱 (衊構淵顧築鏇鬱網蓋醖, 餘鏇築夢獵簾淵鬱積網 ~ 餘糧糧獵鑰夢製醖壓艱) 更多
NCT02684396 (CTgov)	临床1期	-	39	TAK-648 (Cohort 1: TAK-648 0.05 mg)	範鹽遞鑰醖齋顧鏇壓糧(鹹遞鏇遞積憲鏇顧膚衊) = 窪鹹築範廠簾鹹築繭觸廠範網鹽衊窪襯齋糧鬱 (鹹齋鹹願壓願範淵艱淵, 襯鬱艱蓋鏇壓壓廠鹽衊 ~ 蓋廠構遞築觸繭淵網鑰) 更多	-	2016-07-13
				TAK-648 (Cohort 2: TAK-648 0.15 mg)	範鹽遞鑰醖齋顧鏇壓糧(鹹遞鏇遞積憲鏇顧膚衊) = 鏇廠鬱夢壓鏇衊鑰衊製廠範網鹽衊窪襯齋糧鬱 (鹹齋鹹願壓願範淵艱淵, 餘膚鑰簾積淵鏇範願餘 ~ 餘願窪顧選築淵構鹽齋) 更多