A 6-week, Multi-centre, Randomised, Double-blind (Participant and Investigator), Placebo-controlled, Dose-finding Trial to Evaluate the Efficacy, Tolerability, and Safety of Different Doses of Oral BI 1569912 in Patients With Major Depressive Disorder

This study is open to adults between 18 and 65 years of age with a type of depression called major depressive disorder. The purpose of the study is to find out whether a medicine called BI 1569912 helps people with depression.
Participants are put into 4 groups randomly, which means by chance. Three of the 4 groups take different doses of BI 1569912 and 1 group takes placebo. Placebo tablets looks like BI 1569912 but do not contain any medicine. Participants take the tablets once a day for 6 weeks.
Participants are in the study for about 2.5 months. During this time, they visit the study site at least 7 times. At the visits, doctors and their staff ask participants about their depression symptoms. At the end of the study, the results are compared between the groups to see whether the treatment works. The doctors also regularly check the general health of participants and take note of any unwanted effects.

开始日期2024-10-01

申办/合作机构

Boehringer Ingelheim GmbH

CTR20242430 / Recruiting临床2期

一项在抑郁症患者中评价不同剂量口服BI 1569912作为添加治疗的疗效、耐受性和安全性的为期6周的II期、多中心、随机、双盲（受试者和研究者）、安慰剂对照、剂量探索试验

本试验的总体目的是评估BI 1569912与安慰剂相比在对持续接受抗抑郁治疗应答不足的MDD患者中作为添加治疗药物的剂量范围数据，提供临床概念验证（PoCC），并为关键研究的剂量选择提供支持。

开始日期2024-09-03

申办/合作机构

勃林格殷格翰（中国）投资有限公司

[+4]

NCT06520553 / Completed临床1期

A Double-micro-tracer Human Absorption, Distribution, Metabolism and Excretion (hADME) and Absolute Bioavailability Trial After a Single Oral Dose of BI 1569912 (C-14) and a Single, Concomitant, Intravenous Micro-dose of BI 1569912 (C-13) in Healthy Male Subjects (a Phase I, Open-label, Non-randomised, Single-dose, Fixed-sequence Trial)

The main objectives of this trial are:
* To investigate basic pharmacokinetics of BI 1569912 and total radioactivity, including mass balance, excretion pathways and metabolism following oral administration of BI 1569912 (C-14) to healthy male subjects (test treatment, T).
* To investigate the absolute bioavailability of BI 1569912 as single oral solution dose, using a single, concomitant intravenous micro-tracer administration of BI 1569912 (C-13) (reference treatment, R)

开始日期2024-08-26

申办/合作机构

Boehringer Ingelheim GmbH

100 项与 BI-1569912 相关的临床结果

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100 项与 BI-1569912 相关的转化医学

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100 项与 BI-1569912 相关的专利（医药）

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项与 BI-1569912 相关的新闻（医药）

2024-03-15

·医药观澜

治疗抑郁症，勃林格殷格翰1类新药在中国获批临床

▎药明康德内容团队编辑近日，中国国家药监局药品审评中心（CDE）官网公示，勃林格殷格翰（Boehringer Ingelheim）申报的1类新药BI1569912片获批临床，拟作为添加治疗用于抑郁症。公开资料显示，BI1569912是一款选择性NR2B负变构调节剂。截图来源：CDE官网非选择性N-甲基-D-天冬氨酸（NMDA）受体阻滞剂类产品如氯胺酮和艾氯胺酮等已在临床研究中证实对重度抑郁症（MDD）患者有效。但由于出现精神病样效应的概率较高，这些药物的使用受限。NR2B亚基被认为是介导氯胺酮疗效的关键，针对该靶点的药物有望成为潜力抗抑郁药。BI1569912正是一种含NR2B-NMDA受体的新型负变构调节剂，拟开发用于治疗重度抑郁症。一项发表于Biological Psychiatry上的临床前研究显示，BI1569912对含NR2B的离子通道抑制具有纳摩尔活性和高选择性。BI1569912在小鼠中显示抗抑郁样作用，重复给药后效应量与对照的(S)-氯胺酮相当，未诱导耐受性。此外，BI1569912可显著调节大鼠的硬膜外脑电图（EEG）信号。与(S)-氯胺酮相比，BI1569912导致的精神病样特征更轻微，仅在高剂量时观察到。综上，这些发现表明BI1569912是重度抑郁症治疗的一种有前景的治疗选择。ClinicalTrials官网显示，勃林格殷格翰目前正在进行一项2期、6周、多中心、随机、安慰剂对照、剂量探索试验，以评估口服不同剂量BI1569912作为抑郁症辅助治疗的疗效、耐受性和安全性。本次该药在中国获批临床，意味着其也将在中国开展临床研究。参考资料：[1]中国国家药监局药品审评中心（CDE）官网. Retrieved Mar 14, 2024, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d[2] Just SCeci A Ferger, Boris Draheim HJ Giovannini, Riccardo Rosenbrock,et al. (2022) P376. Preclinical Pharmacological Characterization of the Selective NR2b Negative Allosteric Modulator BI 1569912 With Potential to Treat MDD. Biological psychiatry. From https://careers.boehringer-ingelheim.com/biberach/what-we-do/publications/articles/p376-preclinical-pharmacological-characterization-of-the-selective-nr2b-negative-allosteric-modulator-bi-1569912-with-potential-to-treat-mdd[3] A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine. From https://classic.clinicaltrials.gov/ct2/show/NCT06280235?term=BI+1569912&draw=2&rank=2本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

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100 项与 BI-1569912 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
抑郁症	临床2期	美国	Boehringer Ingelheim Pharma GmbH & Co., KG	2024-03-27
抑郁症	临床2期	美国	Boehringer Ingelheim International GmbH	2024-03-27
抑郁症	临床2期	日本	Boehringer Ingelheim Pharma GmbH & Co., KG	2024-03-27
抑郁症	临床2期	日本	Boehringer Ingelheim International GmbH	2024-03-27
抑郁症	临床2期	比利时	Boehringer Ingelheim International GmbH	2024-03-27
抑郁症	临床2期	比利时	Boehringer Ingelheim Pharma GmbH & Co., KG	2024-03-27
抑郁症	临床2期	保加利亚	Boehringer Ingelheim Pharma GmbH & Co., KG	2024-03-27
抑郁症	临床2期	保加利亚	Boehringer Ingelheim International GmbH	2024-03-27
抑郁症	临床2期	捷克	Boehringer Ingelheim Pharma GmbH & Co., KG	2024-03-27
抑郁症	临床2期	捷克	Boehringer Ingelheim International GmbH	2024-03-27