药物开发 药物开发
Mona Darwish1, Bryan Dirks1, Xiaoshu Feng1
1Acadia Pharmaceuticals Inc., Princeton, NJ, USA.
Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 26, 2025
概括
食物摄入不会显著影响ACP-204的吸收,它是一种5-HT2A受体对手. 这种试验性药物被发现是安全的,并且在健康的参与者中耐受良好,不管他们吃了多少饭.
科学领域:
- 药理学 药理学是指药理学的学科.
- 药物开发 药物开发
- 临床试验 临床试验
背景情况:
- ACP-204是一种针对5-HT2A受体的研究药物.
- 食品药物相互作用可以显著影响药物药理动力学 (PK) 和药理动力学.
- 评估食品对ACP-204 PK和安全性的影响对于其治疗应用至关重要.
研究的目的:
- 评估食物摄入对ACP-204的PK的影响.
- 评估ACP-204在食和禁食条件下的安全性和耐受性.
- 为了确定ACP-204在与高脂肪餐一起或不使用时的生物等价性.
主要方法:
- 一个第一阶段,随机化,开放标签,健康参与者的交叉研究.
- 在禁食和高脂肪饮食条件下,服用一次60毫克口服剂量的ACP-204.
- 使用混合效应模型分析PK参数 (AUC,Cmax);通过不良事件和临床监测评估安全性.
主要成果:
- 90%的AUC和Cmax比率的CI (食/禁食) 处于生物等效限 (80%-125%) 之内.
- 食物摄入对ACP-204吸收程度没有显著影响,但稍微延迟了Tmax约3小时.
- ACP-204安全且耐受良好;没有报告严重不良事件,并且在食和禁食状态之间没有观察到安全差异.
结论:
- ACP-204在食和禁食条件下表现出生物等价性,表明食物对吸收率或程度没有显著的影响.
- 单次60毫克的ACP-204剂量是安全的,并且在健康人群中通常耐受良好.
- 这些发现支持ACP-204的灵活剂量与或没有食物.
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