Kalgutkar Amit S, Obach R Scott, Maurer Tristan S
Pharmacokinetics, Dynamics and Metabolism Department, Pfizer Global Research & Development, Groton, CT 06340, USA.
Curr Drug Metab. 2007 Jun;8(5):407-47. doi: 10.2174/138920007780866807.
Cytochrome P450 constitute a superfamily of heme-containing enzymes that catalyze the oxidative biotransformation of structurally diverse xenobiotics including drugs. Inhibition of P450 enzymes is by far the most common mechanism which can lead to DDIs. P450 inhibition can be categorized as reversible (competitive or non-competitive) or irreversible (mechanism-based inactivation). Mechanism-based P450 inactivation usually involves bioactivation of the xenobiotic to a reactive intermediate, which covalently modifies an active site amino acid residue and/or coordinates to the heme prosthetic group. Covalent modification of P450 enzymes can also lead to hapten formation and can in some cases trigger an autoimmune response resulting in toxicological consequences. Compared to reversible inhibition, irreversible inhibition more frequently results in unfavorable DDIs as the inactivated P450 enzyme has to be replaced by newly synthesized protein. For these reasons, most drug metabolism groups within pharmaceutical companies have well-established screening paradigms to assess mechanism-based inactivation of major human P450 enzymes by new chemical entities followed by in-depth mechanistic studies to elucidate the mechanism of P450 inactivation when a positive finding is discerned. A deeper understanding of the process leading to enzyme inactivation by drug candidates can lead to rational chemical intervention strategies to circumvent the P450 inactivation/bioactivation liability. Apart from structure-activity relationship studies, methodology to predict the magnitude of in vivo metabolic DDIs using in vitro P450 inactivation data and predicted human pharmacokinetics of the candidate drug also exists and can be utilized to project the extent of clinical DDIs against P450 enzyme-specific substrates. In this review, a comprehensive analysis of the biochemical basis and known structure-activity relationships for P450 inactivation by xenobiotics is described. In addition, the current state-of-the-art of the methodology used in predicting the magnitude of DDIs using in vitro P450 inactivation data and human pharmacokinetic parameters is discussed in detail.
细胞色素P450构成了一个含血红素的酶超家族,可催化包括药物在内的结构多样的外源性物质的氧化生物转化。P450酶的抑制是迄今为止导致药物相互作用(DDIs)最常见的机制。P450抑制可分为可逆性(竞争性或非竞争性)或不可逆性(基于机制的失活)。基于机制的P450失活通常涉及外源性物质生物活化成反应性中间体,该中间体共价修饰活性位点氨基酸残基和/或与血红素辅基配位。P450酶的共价修饰也可导致半抗原形成,在某些情况下可引发自身免疫反应,从而产生毒理学后果。与可逆性抑制相比,不可逆性抑制更常导致不良的药物相互作用,因为失活的P450酶必须由新合成的蛋白质替代。出于这些原因,制药公司内的大多数药物代谢团队都有成熟的筛选模式,以评估新化学实体对主要人类P450酶的基于机制的失活,随后进行深入的机制研究,以阐明当发现阳性结果时P450失活的机制。对候选药物导致酶失活过程的更深入理解可带来合理的化学干预策略,以规避P450失活/生物活化风险。除了构效关系研究外,还存在利用体外P450失活数据和候选药物的预测人体药代动力学来预测体内代谢性药物相互作用程度的方法,可用于预测针对P450酶特异性底物的临床药物相互作用程度。在本综述中,描述了对外源性物质使P450失活的生化基础和已知构效关系的综合分析。此外,还详细讨论了利用体外P450失活数据和人体药代动力学参数预测药物相互作用程度的方法的当前技术水平。