A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, 3-Part Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-951 in Healthy Subjects

Feeling sick in the stomach (nausea) or throwing up (vomiting) are among the most common symptoms during treatment with medicines. It is hoped that a medicine called TAK-951 may help people to not feel sick in the stomach or throw up. The main aim of this study is to learn about side effects of TAK-951 when given as a single or multiple doses to healthy adults. Side effects are medical problems thought to be caused by the study treatment. Another aim is to learn how a healthy adult's body processes TAK-951 (this is called pharmacokinetics or PK). In this study, participants will receive either TAK-951 or placebo. The placebo looks like TAK-951 but does not have any medicine in it. Both TAK-951 and placebo will be given as an injection directly under the skin. This is called subcutaneous or subcutaneous (SC).
The study will be conducted in 3 parts:
* In Part 1, participants will be given one SC injection of either TAK-951 or placebo.
* In Part 2, participants will receive up to three daily SC injections of either TAK-951 or placebo of the same dose
* In Part 3, participants will receive one SC injection of either TAK-951 or placebo and another SC injection up to 1 week later.
Participants will be checked for their health either 28 days after the last injection (Parts 1 and 2) or 14 days after the last injection (Part 3).

开始日期2022-01-07

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

NCT04557189 / Completed临床2期

A Randomized Double-Blind, Sponsor-Open, Double-Dummy, Proof of Concept Phase 2 Study to Evaluate the Efficacy and Safety of TAK-951 Versus Ondansetron in the Prophylaxis of Postoperative Nausea and Vomiting in High-Risk Subjects

Some adults are at a higher risk of feeling sick (nausea) or being sick (vomiting) after they have surgery. In this study, these adults will have planned surgery. The main aim of this study is to learn if TAK-951 stops these adults from getting nausea or vomiting after surgery. This will be compared with another medicine called ondansetron. Another aim is to check for side effects from the study medicines.
Before surgery, the study doctor will check who can take part in this study. Those who can take part will be picked for either Treatment Group A or Treatment Group B by chance.
Treatment Group A: Just before surgery, participants will receive a placebo slowly through a vein (infusion). Just before the end of the surgery, they will receive TAK-951 as an injection under the skin.
Treatment Group B: Just before surgery, participants will receive ondansetron slowly through a vein (infusion). Just before the end of the surgery, they will receive a placebo as an injection under the skin. In this study, a placebo will look like TAK-951 but will not have any medicine in it.
Participants will not know which study medicines they received, or in which order, nor will their study doctors or surgeons. This is to help make sure the results are more reliable.
Participants will stay in the hospital for 24 hours after their surgery so that the study doctors can check for nausea and vomiting. The study doctors will also check for side effects from the study medicines.
Participants will visit the hospital for a check-up 14 days later.

开始日期2020-10-20

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

NCT04486950 / Completed临床1期

A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-951 in Healthy Subjects Following Intravenous Administration

It is hoped that a medicine called TAK-951 will eventually be used to treat nausea and vomiting. Before then, the sponsor needs to understand how the body processes TAK-951 in healthy adults.
The main aims of this study are as follows:
To check for side effects from TAK-951 when given at a slow and fast infusion rate.
To learn how much TAK-951 participants can receive without getting side effects from it.
Participants will receive a single infusion of either TAK-951 or placebo. In this study, a placebo looks like TAK-951 but does not have any medicine in it. Participants will receive either a low dose or high dose of TAK-951. The infusion will take from 1-3 hours.
Participants will stay in the study clinic for about 4 days to receive the study medicine (TAK-951 or placebo) and check for side effects. They will have follow-up visits at the clinic about 2 weeks and 4 weeks after treatment.

开始日期2020-07-07

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

100 项与 TAK-951 相关的临床结果

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100 项与 TAK-951 相关的转化医学

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100 项与 TAK-951 相关的专利（医药）

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项与 TAK-951 相关的新闻（医药）

2024-05-14

·药精通Bio

武田年报终止项目一览

深度聚焦多肽、多肽偶联药物研发、质控、工艺开发，7月相约苏州，联系电话181 1603 6798日企财报年通常从4月起计。昨天武田公布了2023财年的年度报告。武田利润的急剧下滑，原因包括一些畅销和高利润药物（例如多动症药物 Vyvanse）的专利最近到期，给公司的财务带来压力。武田预计下一个财年投入约 9 亿美元的重组成本扭转局面。公司目标是从 2025 年起每年将核心营业利润率提高 1% 至 2.5%，最终目标在 30%。武田首席执行官 Christophe Weber 在一份公司声明中表示：“展望 2024 财年，我们预计将有6个项目处于3期开发中。” “通过后期开发推进这些有前景的疗法，同时适度增加我们的生物制药研发投资，需要严格的优先顺序、效率和组织敏捷性。”共有 18 个药物项目现已从1期或2期研究中剔除，尽管 TAK-007 等一些项目将继续在其他适应症中开发。这比 2 月份的演示中列出的 11 个项目有所增加。有三个临床中期的癌症疗法被终止：TAK-573（Modakafusp Alfa）、TAK-981（subasumstat）和细胞疗法 TAK-007。TAK-573（Modakafusp Alfa）是一款first-in-class的免疫靶向减毒细胞因子，将减毒干扰素α-2b(IFNα2b)片段递送至表达CD38肿瘤细胞，有潜力在保证安全性的同时提高疗效，曾被寄予希望。但2月份武田已宣布终止了该项目。小分子sumo抑制剂TAK-981（subasumstat）也被终止。武田研发总裁Andrew Plump在年初筛选了若干有前景的癌症药物时将该分子列为值得关注的候选分子。三个月后TAK-981 作为“当前可用数据和临床开发时间表”确定的优先事项的一部分被终止。武田于 1 月份以入组挑战为由终止了一项血癌试验，并于 3 月份停止了一项远未达到目标的实体瘤研究的招募。CD19 CAR-T疗法TAK-007做出了“数据驱动的决定，停止了 CD19 CAR-NK 细胞治疗 B 细胞恶性肿瘤的临床开发”，但该项目在自身免疫性疾病方面的工作将继续进行。武田还削减了其他项目。TAK-079（mezagitamab）是一种抗 CD38 抗体，此次终止了用于治疗重症肌无力和系统性红斑狼疮的开发。但仍计划在 2024 财年启动治疗原发性免疫性血小板减少症的 3 期试验。用于恶心和呕吐的候选药物 TAK-951 也被淘汰，在其临床数据未达到支持进一步开发所需的标准。TAK-647 是武田在收购 Shire 时获得的一种抗 MAdCAM-1 抗体。Shire 于 2016 年从辉瑞公司获得了该分子的许可，并投入克罗恩病和溃疡性结肠炎的 3 期试验。武田本应剥离该资产，但最终未能找到买家，炎性肠炎的适应症开发失败。而后武田将该抗体作为一种潜在的MASH疗法开发，但作为此次投资组合优先顺序的一部分武田停止了开发。END深度聚焦多肽、多肽偶联药物研发、质控、工艺开发，7月相约苏州，联系电话18116036798戳“阅读原文”立即报名多肽药物论坛吧!

财报细胞疗法免疫疗法临床3期并购

100 项与 TAK-951 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
恶心	临床2期	美国	Takeda Pharmaceutical Co., Ltd.	2020-10-20
术后恶心呕吐	临床2期	美国	Takeda Pharmaceutical Co., Ltd.	2020-10-20
呕吐	临床2期	美国	Takeda Pharmaceutical Co., Ltd.	2020-10-20

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临床结果

适应症

分期

评价

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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


NCT04557189 (CTgov)	临床2期	恶心 \| 术后恶心呕吐 \| 呕吐	89	TAK-951 Placebo+Ondansetron (Ondansetron 4 mg IV)	願網製衊襯壓製積願憲(鏇衊網構構構獵鏇蓋糧) = 繭衊蓋醖構餘醖蓋選廠憲餘齋壓衊獵製醖構願 (鹽糧鏇網繭餘獵鏇鬱網, 鏇淵獵構淵壓襯餘獵觸 ~ 廠願壓網網襯製鏇夢鬱) 更多	-	2023-04-21
				Ondansetron Placebo+TAK-951 (TAK-951 4 mg SC)	願網製衊襯壓製積願憲(鏇衊網構構構獵鏇蓋糧) = 廠糧遞鏇獵醖構獵網網憲餘齋壓衊獵製醖構願 (鹽糧鏇網繭餘獵鏇鬱網, 選製鏇廠糧艱構積選觸 ~ 襯製積淵淵淵淵廠蓋鹽) 更多
NCT04486950 (CTgov)	临床1期	-	32	Placebo (Cohorts 1 to 2, Treatment P1: Placebo Pooled)	醖構鹽壓構顧蓋製齋夢(膚壓糧壓願遞鹹鹹構齋) = 憲積窪遞蓋製願糧鬱鹹憲膚醖選壓憲醖淵網蓋 (鬱構繭襯膚餘壓襯簾顧, 鑰夢餘醖獵鏇網遞鏇範 ~ 獵積鑰廠餘憲憲夢壓艱) 更多	-	2023-03-10
				TAK-951 (Cohort 3, Treatment P2: Placebo)	醖構鹽壓構顧蓋製齋夢(膚壓糧壓願遞鹹鹹構齋) = 衊鑰蓋醖齋窪鏇艱淵觸憲膚醖選壓憲醖淵網蓋 (鬱構繭襯膚餘壓襯簾顧, 膚襯繭齋蓋艱餘鹽壓膚 ~ 顧壓鹽膚構網糧壓觸鬱) 更多