TAK-648(TAK-648) - 药物靶点：PDE4_在研适应症：非酒精性脂肪性肝炎_专利_临床

概要

基本信息

药物类型

小分子化药

别名

靶点

PDE4

作用方式

抑制剂

作用机制

PDE4抑制剂(磷酸二酯酶4抑制剂)

治疗领域

消化系统疾病

在研适应症

非酒精性脂肪性肝炎

非在研适应症

2型糖尿病糖尿病肾病

原研机构

Takeda Pharmaceutical Co., Ltd.

在研机构

Takeda Pharmaceutical Co., Ltd.

ARTham Therapeutics, Inc.

非在研机构-

权益机构-

最高研发阶段临床1期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

5

项与 TAK-648 相关的临床试验

JPRN-jRCT2071210034

/ Completed临床2期IIT

Phase 2 clinical trial evaluating the efficacy and safety of ART-648 in patients with bullous pemphigoid

开始日期2021-10-12

申办/合作机构-

JPRN-UMIN000034454

/ Completed临床1期IIT

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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1

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: Vollert, S ; Hanauer, G ; 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	-	ARTham Therapeutics, Inc.	-
非酒精性脂肪性肝炎	临床1期	-	Takeda Pharmaceutical Co., Ltd.	-
2型糖尿病	临床前	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

评价

查看全部结果

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)	壓衊糧鑰鹽遞淵夢觸鑰(顧簾觸淵構觸蓋觸膚鹹) = 範鏇蓋衊構壓鹹壓鹹觸鹽憲憲廠糧願鑰鹽範糧 (願築糧襯膚選鏇選餘獵, 製築鹹獵衊繭積廠齋壓 ~ 壓鹹鏇膚鹽壓製壓觸憲) 更多	-	2016-08-31
				TAK-648 (Part 1 Cohort 2: TAK-648 0.80 mg)	壓衊糧鑰鹽遞淵夢觸鑰(顧簾觸淵構觸蓋觸膚鹹) = 醖鬱夢製網襯艱積鑰醖鹽憲憲廠糧願鑰鹽範糧 (願築糧襯膚選鏇選餘獵, 觸鑰膚繭淵繭夢糧積繭 ~ 遞製淵壓鹽壓選獵網網) 更多
NCT02684396 (CTgov)	临床1期	-	39	TAK-648 (Cohort 1: TAK-648 0.05 mg)	鬱簾蓋蓋襯廠鏇選選壓(壓鬱膚齋餘窪繭網範衊) = 醖糧築鹹鑰網壓壓齋製窪築壓築遞積選壓遞夢 (夢憲範繭鹹艱顧製齋衊, 網繭遞醖餘網廠夢膚窪 ~ 夢夢積築選壓構鬱遞獵) 更多	-	2016-07-13
				TAK-648 (Cohort 2: TAK-648 0.15 mg)	鬱簾蓋蓋襯廠鏇選選壓(壓鬱膚齋餘窪繭網範衊) = 製簾衊齋鬱簾顧糧積築窪築壓築遞積選壓遞夢 (夢憲範繭鹹艱顧製齋衊, 餘繭憲壓獵餘齋範範蓋 ~ 齋鑰壓鬱觸鑰衊憲窪鏇) 更多