A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, 3-Period, Incomplete Block Design Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-954 in Healthy Adult Participants

The purpose of this study is to evaluate the safety, tolerability, and PK of single ascending intravenous doses of TAK-954.

开始日期2019-03-08

申办/合作机构

Millennium Pharmaceuticals, Inc.

NCT03827655

/ Completed临床2期

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of 2 Dose Regimens of Intravenous TAK-954 for the Prophylaxis and Treatment of Postoperative Gastrointestinal Dysfunction in Patients Undergoing Large- and Small-Bowel Resection

The main aim of this study is to check for side effects from TAK-954 and whether it speeds up the recovery of gastrointestinal function after small-bowel or large-bowel resection surgery.
Participants will be treated with TAK-954 before surgery and up to 10 days after surgery.

开始日期2019-03-07

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

[+1]

NCT03477903

/ Terminated临床2期

A Phase 2b, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous TAK-954 in Critically Ill Patients With Enteral Feeding Intolerance

The purpose of this study is to assess the treatment effect of intravenous TAK-954 in improving the average daily protein adequacy received through enteral nutrition in critically-ill participants developing EFI.

开始日期2018-08-25

申办/合作机构

Millennium Pharmaceuticals, Inc.

100 项与 TD-8954 相关的临床结果

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100 项与 TD-8954 相关的转化医学

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100 项与 TD-8954 相关的专利（医药）

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项与 TD-8954 相关的文献（医药）

2024-08-01·AMERICAN JOURNAL OF SURGERY

A randomized phase 2 study of the 5-HT4 receptor agonist felcisetrag for postoperative gastrointestinal dysfunction after bowel surgery

Article

作者: Gryder, Ryan ; Kamble, Pravin ; Thakker, Paresh ; Ayad, Sabry ; Williams, James ; Tackett, Jason ; Dukes, George ; Zhang, Yanwei ; Wade, Paul R ; Boeckxstaens, Guy ; Essandoh, Michael

BACKGROUND:

Felcisetrag (5-hydroxytryptamine-4 receptor [5-HT₄] agonist) is under investigation as prophylaxis or active treatment for accelerating resolution of gastrointestinal function post-surgery.

METHODS:

Phase 2, randomized, placebo-controlled, parallel five-arm, double-blind, multicenter study (NCT03827655) in 209 adults undergoing open or laparoscopic-assisted bowel surgery. Patients received intravenous placebo, felcisetrag 0.1 mg/100 mL or 0.5 mg/100 mL pre-surgery only, or pre-surgery and daily post-surgery until return of gastrointestinal function or for up to 10 days.

PRIMARY ENDPOINT:

time to recovery of gastrointestinal function.

RESULTS:

Median time to recovery of gastrointestinal function was 2.6 days for both felcisetrag 0.5 mg daily and 0.5 mg pre-surgery versus 1.9 days for placebo (p > 0.05). There were no notable differences in adverse events between treatment arms.

CONCLUSIONS:

Felcisetrag was well tolerated with no new safety concerns. However, no clinically meaningful difference in time to recovery of gastrointestinal function versus placebo was observed. Further investigation of the utility of 5-HT₄ agonists in complicated, open abdominal surgeries may be warranted.

2024-01-08·Cureus

Safety and Efficacy of Highly Selective 5-Hydroxytryptamine Receptor 4 Agonists for Diabetic and Idiopathic Gastroparesis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Review

作者: Zaher, Eli A ; Loganathan, Priyadarshini ; Patel, Parth ; Khataniar, Himsikhar ; Ebrahim, Mohamed A

Gastroparesis significantly affects quality of life and healthcare expenditure. Effective treatment options are limited, and the utility of current prokinetic agents is inhibited by serious adverse effects. There exists an unmet need for prokinetic agents demonstrating both efficacy and an acceptable adverse effect profile. Highly selective 5-Hydroxytryptamine receptor 4 (5-HT4) agonists have exhibited clinical efficacy and safety in randomized controlled trials (RCTs). Consequently, we conducted a meta-analysis to comprehensively assess the safety and efficacy of these highly selective agents. Multiple databases, including PubMed, Scopus, and Embase, were systematically screened from inception until September 2023. Only RCTs evaluating the efficacy and safety of highly selective 5-HT4 agonists for gastroparesis were included. Key outcomes of interest included the pooled rates of Gastroparesis Cardinal Symptom Index (GCSI) scores, gastric emptying time (GET), and adverse event rates in each group. We adhered to standard meta-analysis methodology utilizing the random-effects model, with heterogeneity assessed by I² statistics. Our analysis identified six RCTs, comprising 570 patients with diabetic (48%) or idiopathic (51%) gastroparesis, with mean ages of 46 and 45.9 years in the intervention and placebo groups, respectively. In the meta-analysis, highly selective 5-HT4 agonists demonstrated significantly superior pooled GCSI scores compared to placebo (mean difference: 4.283, (1.380, 7.186), p<0.05). Pooled GET was also significantly improved with 5-HT4 agonists compared to placebo (mean difference: 2.534, (1.695, 3.373), p<0.05). Although pooled rates of total adverse events were higher with 5-HT4 agonists (mean difference: 6.975, (1.042, 46.684), p<0.05), rates of specific adverse events such as diarrhea, abdominal pain, and headaches were comparable. In conclusion, this meta-analysis underscores a statistically significant improvement in GET and GCSI scores among patients receiving highly selective 5-HT4 agonists (Velusetrag, Felcisetrag, Prucalopride) for both diabetic and idiopathic gastroparesis. While the overall adverse effect profile is deemed acceptable, larger studies with extended follow-up periods are needed to investigate rare and/or serious adverse events. Moreover, future high-quality RCTs comparing the efficacy and safety of these novel agents with currently available agents are essential to further validate these findings.

2022-08-01·Journal of clinical pharmacology3区 · 医学

The Effect of Hepatic Impairment on the Pharmacokinetics of Intravenously Administered Felcisetrag (TAK‐954)

3区 · 医学

Article

作者: Czerniak, Richard ; Rosario, Maria ; Cieslarová, Blanka ; Kupčová, Viera ; Lock, Ruth ; Dong, Cheng ; Dukes, George

Abstract:

Felcisetrag (formerly known as TAK‐954) is a selective serotonin receptor agonist under investigation for use in patients with postoperative gastrointestinal dysfunction. The safety, tolerability, and pharmacokinetics (PK) of intravenous (i.v.) felcisetrag have been studied, but little is known about the effect of hepatic impairment on the PK of the drug. This phase 1, non‐randomized, open‐label study compared the PK of a single 60‐minute i.v. infusion of felcisetrag between healthy individuals (n = 8) and patients with moderate (n = 10) or severe (n = 7) hepatic impairment. The primary study end points were the total and free maximum observed plasma concentration of felcisetrag at the end of infusion (Cmax), area under the concentration–time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUClast), and AUC from time 0 to infinity (AUCinf). Concentration–time profiles of felcisetrag were similarly shaped between groups but revealed lower concentrations of total plasma felcisetrag with increasing severity of hepatic impairment, whereas concentrations of free felcisetrag increased. The ratios of AUClast and AUCinf for patients with severe hepatic impairment were up to 29.3% lower for total felcisetrag and up to 29.2% higher for free felcisetrag than found in healthy individuals (P < .05). Infusions were well tolerated with no discontinuations, severe adverse events, or deaths during the study. Overall, the effect of hepatic impairment on exposure to felcisetrag was minimal, suggesting that dose adjustment may be unnecessary in patients with hepatic impairment.

项与 TD-8954 相关的新闻（医药）

2023-07-10

·药融圈

2023年上半年，消失的管线

▲8月03-04日 CMC-China大会 · 限时免费扫码报名中注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。管线消失，但带给我们的启示不会消失。他山之石，可以攻玉。跨国药企在创新方面一直走在前列，其管线项目的布局调整，值得我们密切关注。据不完全统计，上半年辉瑞、BMS、诺华、罗氏、默沙东、GSK、武田、阿斯利康、第一三共等大药企合计砍掉了超50个管线项目，涉及ADC、CGT疗法、新冠药物、小核酸、疫苗和GLP-1等各个方面，或因为技术不成熟，难成药；或由于竞争格局发生变化以及战略失误等原因，我们具体来看看。辉瑞在2023年上半年终止10多个研发项目。今年2月初，辉瑞发布的财报显示，消减了8个研发项目。1.删掉了recicept研发项目，这是一种治疗软骨发育不全的侏儒症的药物，是辉瑞在2019年收购罕见疾病公司Therachon的核心产品。当时，辉瑞公司预付了3.4亿美元。2.削减两个Paxlovid的适应症，这两个适应症在各自的III期试验中都失败了——一个用于标准风险患者，一个用于暴露后预防。3.停止了四种早期候选药物的研发，其中包括一种正在健康志愿者身上测试的治疗自身免疫性疾病的药物。该药被授予孤儿药称号，用于治疗一种称为慢性炎症性脱髓鞘多发性神经病的神经疾病。此外，该公司正在开发一种用于实体瘤的生物制剂，以及用于黑色素瘤和转移性乳腺癌的激酶抑制剂。辉瑞在年初时候表示，将缩小对罕见疾病和癌症的关注，未来计划在血液学和基因编辑等目前的重点领域加大投入。2023年5月初，辉瑞在一季报中更新了其研发管线，其中有6个研发项目已终止，101个项目仍处于临床或注册阶段。图片来源：辉瑞官网辉瑞公司还在1季报中披露了自1月31日以来剔除的6个研发项目，如下图所示：来源：官网BMS在2023年2月发布的财报显示，至少9个管线被砍，包括CTLA-4和TIGIT等靶点。其中在早期研发方面，BMS削减了6项肿瘤资产，包括一项2期抗CTLA-4候选药物BMS986218、一项纤维化候选药物和两项免疫学资产。大多数肿瘤资产为1期实体瘤管线，包括STING激动剂、IL-12 F、SIRPα拮抗剂和anti-CTLA-4药物。此外，BMS也削弱了其血液瘤的前景，终止了处于1期的ROR CAR-T疗法的开发，同时BMS还终止抗TIGIT药物BMS-986207的2期临床试验，该试验是Yervoy和Opdivo三联疗法的一部分，主要是出于安全考虑。罗氏在2023年2月财报显示，12款产品减值超31亿美元。2022年资产减值超31美元，涉及12款主要产品，其中最大的一笔是抗癌药物Gavreto减值7.26亿美元，这是一种口服RET靶向疗法，用于治疗年龄≥12岁的甲状腺癌儿童和成人患者。此外，2022年罗氏在基因疗法方面资产减值金额约7.5亿美元。2023年5月，罗氏终止精神病新药II期临床研究。美国临床试验网显示，罗氏终止了其精神分裂症候选药物ralmitaront的II期（NCT03669640）临床试验，该研究旨在评估ralmitaront相较于安慰剂用于治疗精神分裂症或分裂情感障碍阴性症状患者疗效。试验终止的原因是中期分析表明ralmitaront不太可能在该研究中达到主要终点。2023年6月，据媒体报道，罗氏将终止推进反义寡核苷酸疗法rugonersen治疗天使综合征的临床开发。罗氏表示，该疗法的耐受性良好，这一决定无关安全性问题。停止rugonersen开发的决定并不意味着罗氏放弃天使综合征领域。罗氏补充说，正在进行的alogabat治疗天使综合征的II期研究将不受影响。该小分子是一款GABRA5正向变构调节剂。默沙东停止3个项目。据2月份发布的财报更新显示，默沙东公司放弃了基孔肯雅热(chikungunya)候选疫苗，该疫苗已完成II期研究。默沙东公司于2020年通过收购Themis Bioscience 获得了该疫苗。此外，默沙东还放弃了Lenvima的胶质母细胞瘤适应证，该公司一直在研究Lenvima与Keytruda联合用于LEAP项目的适应证。在一封电子邮件中，默克公司告诉Endpoints News:“作为我们常规管道优先排序的一部分，MSD已经选择停止这两个项目。”在1月25日，MSD宣布，在一项中期分析显示生存率没有改善后，MSD还将停止一项Keytruda晚期前列腺癌研究。GSK在2月份发布的财报显示，删除2个项目。GSK从其管线中删除了一种名为GSK3915393的化合物。该化合物可抑制一种称为转谷氨酰胺酶2或TG2的酶，该公司此前一直在研究其在乳糜泻中的应用。当在媒体电话会议上被问及3915393计划时，首席执行官Emma Walmsley证实没有进一步的计划来测试该药物是否用于乳糜泻。另外，GSK也在放弃一种针对金黄色葡萄球菌的重组蛋白疫苗，该疫苗已进入第二阶段。年初GSK还指出，它“决定停止对细胞和基因疗法的投资，最显著的是，本着在研发方面“极其严格”的精神，断绝了与Lyell、Adaptimmune和Immatics的联盟。武田在2023年5月披露的财报显示，终止6个研发项目。1.TAK-954。武田将放弃II期临床试验失败的术后胃肠功能障碍候选药物TAK-954。这是一款选择性5-HT4受体激动剂，从爱尔兰公司Theravance Biopharma授权引进，由此也结束了两家公司之间的合作。2.TAK-018（sibofimloc）。sibofimloc是一款与法国Enterome Biosciences公司合作开发的FimH 粘附抑制剂，用于克罗恩病（CD）。此款药物终止研发的原因是因为未能招募到足够的患者进行II期试验。3.Ninlaro (ixazomib)。Ninlaro是FDA批准的首个口服蛋白酶体抑制剂，用于治疗复发性或难治性多发性骨髓瘤（R/R MM）。根据研究的最终分析，武田决定停止在美国和欧洲开发新的适应症——治疗首次发作的多发性骨髓瘤，而无需造血干细胞移植。4.LIVTENCITY（马里巴韦）。在与监管当局审查了试验结果后，武田停止了该药物在造血干细胞移植后巨细胞病毒感染的一线治疗适应症的开发。5.Taxilo。该药物在缓激肽介导的血管性水肿研究中未能达到其主要终点。6.Zejura (niraparib)。武田停止Zejura在乳腺癌研究中的患者招募。Zejura是一款PARP抑制剂，目前用于卵巢癌。第一三共终止了2个研发项目。2023年5月份，第一三共发布2022财年（2022年4月1日-2023年3月31日）财报显示，终止了2个研发项目。包括用于杜氏进行性肌营养不良（DMD）的核酸药物DS-5141和用于进行性骨化性纤维发育不良（FOP）的药物DS-6016DS-5141是一款有望治疗DMD的核酸药物，可以跳过45外显子拼接，在信使RNA的处理过程中，在肌细胞中产生不完整但具有功能的肌营养不良蛋白。虽然在临床试验中显示出了一定的有效性，但根据目前的数据判断，想要进一步开发比较困难。DS-6016是一款有望治疗FOP的抗ALK2抗体，由于需要花费时间解决相关抗体非临床试验中发现的潜在安全性风险，因此被判定失去了竞争力，所以终止了开发。阿斯利康砍掉2个GLP-1管线和IL-4Rα拮抗剂开发。2023年6月20日，据外媒fiercebiotech报道，阿斯利康AZD0186（GLP-1R激动剂）没有达到预期目标，未显示出足够的差异性以超过当前的护理标准，故决定终止这项临床研究AZD0186处于1期临床研究阶段，用于治疗2型糖尿病，此项研究主要评估AZD0186 的安全性、耐受性和药代动力学。除了AZD0186，4月12日，阿斯利康宣布放弃一项关于Cotadutide（GLP-1R/GCGR 双重激动剂、日制剂）的 IIb/III 期临床研究，针对伴有肝纤维化但无肝硬化的非酒精性脂肪肝炎（NASH）患者。Cotadutide数据疗效不错，但和已上市的几款药物相比，并不具备竞争优势。阿斯利康表示将重点开发另一款GLP-1R/GCGR激动剂AZD9550（周制剂），目前仍处于临床前开发阶段。6月21日，Pieris Pharmaceuticals宣布收到阿斯利康向其传达的终止elarekibep开发的决定。该决定基于一项为期13周的非临床GLP毒理学研究，与正在进行的临床研究无关，但研究结果不支持elarekibep的长期使用以及临床后期开发。除了跨国大药企砍管线以外，还有不少中小药企也在陆续砍管线，ADC领域也有知名公司砍管线。今年5月份，ADC Therapeutics也砍掉了2道ADC管线，分别是ADCT-212（治疗前列腺癌的临床前抗体药物结合物）和ADCT-701（靶向DLK-1的ADC药物）。ADC Therapeutics执行官补充说，临床前项目的削减将使公司有更多的资金用于上市产品Zynlonta和其后期临床项目。总结此外，据公开报道，强生上半年还搁置了2个“双抗管线”研发；诺华调整Cosentyx、CAR-T疗法、TIGIT 抗体等研发计划；吉利德暂停3个项目，包括IRAK4抑制剂的两个适应症以及一个实体瘤候选物；礼来放弃了一种治疗糖尿病和非酒精性脂肪性肝炎的第一阶段候选药物，赛诺菲也停止了对BTK抑制剂tolebrutinib用于重症肌无力（MG）的III期临床研究等项目，艾伯维也终止开发一款自免ADC药物ABBV-154。管线项目的消失提醒我们，在投入大量资源和精力之前，必须充分评估项目的可行性和潜在风险。这要求药企更加注重风险管理和决策的科学性，以减少研发过程中的失败率。参考资料：各公司官网https://endpts.com/news/https://www.fiercepharma.com/版权声明：本文转自药事纵横，如不希望被转载的媒体或个人可与我们联系，我们将立即删除关于CMC-China 博览会融合产业力量，重构行业未来！本次CMC-China博览会汇聚300+医药及上下游全产业链的企业积极报名参展，数千名专业观众报名参观，展会现场将举办15场专业论坛。充分体现了“医药人办医药展，专业人办专业展”的理念。了解更多：数据看展会丨一文看懂第五届CMC-China制药博览会观众亮点点分享点点赞点在看

财报免疫疗法孤儿药疫苗细胞疗法

2023-05-13

·GBIHealth

武田2022 | 全球下降0.8%，停止基因治疗项目、II期药物开发

点击蓝字GBIHealth关注我们SUBSCRIBE to us日本武田制药公司本周发布了2022财年（2022年4月-2023年3月）业绩，全球收入同比下降0.8%（按固定汇率计算，下同），至4万亿日元（300亿美元），部分原因是日本剥离的糖尿病产品组合的销售损失，尽管业务势头强劲。来源：武田财报肠胃病部门报告期内增长了8.7%，达到1.1万亿日元，罕见病部门也增长了4.8%，达到7230亿日元，血浆衍生疗法和免疫业务增长了15.3%，达到6780亿日元；神经科学增长了12.1%，达到6380亿日元，肿瘤学下降14.4%，至4390亿日元，其他治疗领域暴跌32.4%，至4550亿日元。武田最畅销的药物是自身免疫性疾病药物安吉优（维得利珠单抗），销售额为7030亿日元（52亿美元），其次是免疫球蛋白产品，销售额为5220亿日元（39亿美元），中枢神经系统（CNS）兴奋剂二甲磺酸赖右苯丙胺（lisdexamfetamine dimesylate），销售额为4590亿日元（34亿美元）。从地区来看，日本下滑22.5%，至5120亿日元，所有其他地区都出现了增长，其中美国增长2.0%，至2.1万亿日元；欧洲和加拿大增长5.1%，至8430亿日元；除日本外的亚洲增长2.0%至2250亿日元；拉丁美洲增长8.0%，至1600亿日元；俄罗斯/独联体增长9.5%，至880亿日元；其他市场增长41.3%，至950亿日元。此外，报告指出，中国是胃肠道疾病治疗药物Takecab/Vocinti（沃诺拉赞）、白蛋白产品Flexbumin（人白蛋白）和非小细胞肺癌（NSCLC）药物安伯瑞（布加替尼）的增长驱动因素。来源：武田财报精简管线产品管线方面，武田计划放弃继续开发腺相关病毒（AAV）基因疗法项目和罕见血液病药物。这一消息将影响AAV领域的药物发现和临床前研究团队，以及罕见血液病领域的研究团队。做出这一决定是为了将资源重新集中在优先管线上。此外，武田还将放弃II期临床试验失败的术后胃肠功能障碍候选药物TAK-954。这是一款选择性5-HT4受体激动剂，从爱尔兰公司Theravance Biopharma授权引进，由此也结束了两家公司之间的合作。克罗恩病（CD）候选药物sibofimloc也被放弃继续开发，因为未能招募到足够的患者进行II期试验。Sibofimloc是一种肠道限制性的，具有口服活性的 FimH 粘附抑制剂, 2018年从法国公司Enterome，武田曾为此支付5000万美元预付款。由于精简管线，武田预计将裁减近200个工作岗位。有奖调研点击阅读原文立即参与活动

财报引进/卖出基因疗法临床3期临床2期

2023-05-11

·FierceBiotech

Takeda cuts 2 midstage GI assets including Crohn's hopeful in latest pipeline cleanup

A phase 2 study of sibofimloc was terminated in March due to recruitment difficulties. Takeda may have caught attention recently for ending work on its early-stage gene therapy R&D, but a close reading of the Japanese pharma’s latest earnings report reveals it has also culled a couple of gastrointestinal assets. The most notable removal in the full-year presentation (PDF) is Crohn’s disease candidate sibofimloc, which was being investigated in a phase 1 trial for the luminal version of the inflammatory bowel disease as well as a phase 2 study of Crohn’s disease of the ileum occurring after surgery. The phase 2 study was terminated due to an inability to recruit enough patients, according to the ClinicalTrials.gov entry, which was last updated in March. The gut-restricted, small-molecule FimH-blocker was designed to treat the underlying cause of Crohn's disease. The therapy was first created by Vertex Pharmaceuticals before being in-licensed by French biotech Enterome, to which Takeda paid $50 million upfront in 2018 to co-develop the therapy. Enterome has gone quiet on sibofimloc since 2021, when the company highlighted research into the drug demonstrating that “blocking the adhesion of overabundant FimH-expressing bacteria to the gut wall is a promising therapeutic mechanism that effectively disarms these virulent bacteria without killing them.” At the time, Takeda’s senior medical director for gastroenterology Vijay Yajnik, M.D., said the research showed “a very promising finding that it exerts its local anti-inflammatory action by blocking pathogenic bacteria without disrupting the commensal gut microbiome.” The demise of sibofimloc is far from the end of Takeda’s Crohn’s ambitions, however. The company, which already has Entyvio on the market for the condition, is planning to launch a phase 2b trial in Crohn’s for its potential psoriasis and arthritis treatment TAK-279 later this year. The other GI asset dumped from Takeda’s pipeline is TAK-954, which was in phase 2 development for postoperative gastrointestinal dysfunction. In an SEC filing to accompany its own earnings results this week, Theravance Biopharma—which licensed the drug to Takeda in 2016—explained that the two companies had mutually agreed to discontinue development of the selective 5-HT4 receptor agonist back in February after it failed the phase 2 study. Takeda’s full-year earnings documents also reaffirmed that the company is dropping its early-stage R&D work in adeno-associated virus-based gene therapies. It was revealed this week that as many as 186 jobs in the pharma’s Massachusetts sites are set to go as a result. The gene therapy retreat could also have an impact on some of Takeda’s partners. In its own earnings report this week, Poseida Therapeutics said it was “in discussions with Takeda about our collaboration following the news that they have made some strategic decisions in their research priorities and will update when appropriate.”

临床2期基因疗法引进/卖出临床失败临床1期

100 项与 TD-8954 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB12725

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
胃肠功能紊乱	临床2期	美国	Takeda Pharmaceutical Co., Ltd.	2019-03-07
胃肠功能紊乱	临床2期	德国	Takeda Pharmaceutical Co., Ltd.	2019-03-07
危重病	临床2期	美国	Millennium Pharmaceuticals, Inc.	2018-08-25
危重病	临床2期	澳大利亚	Millennium Pharmaceuticals, Inc.	2018-08-25
危重病	临床2期	加拿大	Millennium Pharmaceuticals, Inc.	2018-08-25
危重病	临床2期	英国	Millennium Pharmaceuticals, Inc.	2018-08-25
喂养不耐受	临床2期	美国	Millennium Pharmaceuticals, Inc.	2018-08-25
喂养不耐受	临床2期	澳大利亚	Millennium Pharmaceuticals, Inc.	2018-08-25
喂养不耐受	临床2期	加拿大	Millennium Pharmaceuticals, Inc.	2018-08-25
喂养不耐受	临床2期	英国	Millennium Pharmaceuticals, Inc.	2018-08-25

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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


NCT03827655 (CTgov)	临床2期	胃肠功能紊乱	209	TAK-954 Placebo (Placebo)	範觸蓋膚遞鬱範衊壓遞(積網蓋餘鑰顧艱簾顧築) = 顧範夢衊醖鏇窪蓋範製餘衊蓋築選簾觸鏇觸積 (鏇願醖構淵窪蓋膚衊鏇, 鹽餘齋膚築鏇醖顧製範 ~ 醖觸鏇鑰蓋範餘膚艱簾) 更多	-	2023-06-23
				TAK-954 (TAK-954 0.1 mg/100 mL)	範觸蓋膚遞鬱範衊壓遞(積網蓋餘鑰顧艱簾顧築) = 獵築齋廠網廠鑰膚襯醖餘衊蓋築選簾觸鏇觸積 (鏇願醖構淵窪蓋膚衊鏇, 獵齋蓋選廠壓簾鹽壓醖 ~ 顧鬱獵窪淵襯壓淵積鑰) 更多
NCT03173170 (Pubmed)	临床1期	胃肠功能紊乱	10	Felcisetrag alone	鏇顧選構鏇衊鑰廠願觸(鹹襯醖顧簾觸廠鏇夢鑰): geometric mean ratio = 1.06 (90% CI, 0.96 ~ 1.18), P-Value = NA	积极	2022-01-06
				Felcisetrag + Itraconazole
NCT01953081 (Pubmed) 人工标引	临床2期	-	13	TAK-954	夢齋蓋膚齋鏇鹽蓋衊範(遞窪簾衊鹹鏇齋膚簾艱) = 鑰範廠壓願築選製襯鑰願艱遞鑰遞壓壓醖醖構 (膚鏇獵鑰夢構壓簾齋艱 ) 更多	积极	2021-01-01
				metoclopramide	夢齋蓋膚齋鏇鹽蓋衊範(遞窪簾衊鹹鏇齋膚簾艱) = 簾選鏇襯顧淵鏇觸鏇淵願艱遞鑰遞壓壓醖醖構 (膚鏇獵鑰夢構壓簾齋艱 ) 更多
NCT03296787 (CTgov)	临床1期	肾功能不全 \| 终末期肾脏病	32	TAK-954+midazolam+caffeine (Group A: Healthy Participants)	獵鑰淵憲獵夢鬱範鹽淵(艱鹽廠製願壓範構構淵) = 蓋鹽膚醖構鹹鑰選憲願築鬱淵製網憲鏇廠鑰齋 (膚遞夢觸蓋鬱糧夢齋窪, 12.8) 更多	-	2020-08-25
				TAK-954+midazolam+caffeine (Group C: Moderate Renal Impairment)	獵鑰淵憲獵夢鬱範鹽淵(艱鹽廠製願壓範構構淵) = 鹹積積憲選襯蓋構鹽鑰築鬱淵製網憲鏇廠鑰齋 (膚遞夢觸蓋鬱糧夢齋窪, 23.2) 更多
NCT03281577 (CTgov)	临床2期	胃轻瘫 \| 糖尿病性胃轻瘫	36	Placebo (Placebo)	廠積窪遞築膚糧鑰蓋鹹(夢顧鑰簾觸鏇廠憲遞衊) = 艱範獵鏇廠衊顧艱網襯鑰網艱膚膚鬱膚夢鑰糧 (鏇壓願範廠簾壓鬱顧鹹, 23.71) 更多	-	2020-07-15
				TAK-954 (TAK-954 0.1 mg)	廠積窪遞築膚糧鑰蓋鹹(夢顧鑰簾觸鏇廠憲遞衊) = 衊壓憲襯壓繭襯夢築繭鑰網艱膚膚鬱膚夢鑰糧 (鏇壓願範廠簾壓鬱顧鹹, 14.43) 更多
NCT03870555 (CTgov)	临床1期	-	6	TAK-954 (Treatment Dose: TAK-954 0.5 mg)	廠膚願夢衊憲築鏇廠淵 = 繭夢廠醖顧築餘襯構廠製齋積壓襯憲壓艱艱顧 (網憲夢衊範願夢製鏇構, 衊襯獵繭鹹膚顧憲醖夢 ~ 構積範鏇壓積憲顧廠夢) 更多	-	2020-06-24
				TAK-954 (Treatment Dose: TAK-954 1 mg)	廠膚願夢衊憲築鏇廠淵 = 淵鬱淵齋繭夢製襯獵鹹製齋積壓襯憲壓艱艱顧 (網憲夢衊範願夢製鏇構, 鹹淵壓鹽築鬱醖襯繭窪 ~ 鬱襯選範餘製獵鑰襯選) 更多
NCT03277274 (CTgov)	临床1期	肝损伤	25	TAK-954 (Healthy Participants: TAK-954 0.2 mg)	範夢網餘襯襯鬱餘範顧(獵壓憲顧鑰窪膚製憲夢) = 繭齋鹽簾餘積製醖鑰網製衊鏇壓淵觸遞選鹽窪 (艱衊齋積願鏇積簾夢積, 19.1) 更多	-	2019-09-25
				TAK-954 (Group B, Moderate Hepatic Impairment: TAK-954 0.2 mg)	範夢網餘襯襯鬱餘範顧(獵壓憲顧鑰窪膚製憲夢) = 醖顧蓋壓簾獵廠醖膚繭製衊鏇壓淵觸遞選鹽窪 (艱衊齋積願鏇積簾夢積, 25.3) 更多
NCT03477903 (CTgov)	临床2期	危重病 \| 喂养不耐受	1	TAK-954	廠鑰鹽願鑰願鏇憲糧鹹(鏇構壓艱鑰艱獵鏇廠艱) = 醖衊淵獵鹽繭顧獵鏇襯顧獵願鑰夢廠憲鏇淵遞 (襯築膚淵遞遞衊鑰齋鑰, 窪壓築糧製範願淵膚壓 ~ 襯憲鑰齋鹽鹹觸繭蓋鹹) 更多	-	2019-09-24
NCT03500224 (CTgov)	临床1期	-	6	[14C]-TAK-954	簾艱築艱醖積齋壓鏇構(夢鏇窪艱鑰積鑰選鬱鹽) = 衊蓋積窪積遞製製製淵積壓廠餘鹹製觸顧鏇製 (廠膚艱衊餘鏇蓋窪醖選, 3.2) 更多	-	2019-07-29