PHASE I/II, OPEN-LABEL, PHARMACOKINETIC AND SAFETY STUDY OF A NOVEL PROTEASEO

新型蛋白酶的 I/II 期、开放标签、药代动力学和安全性研究

• 批准号: 7603903
• 负责人: MARGARET KHOURY
• 金额: $ 3.09万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603903
• 关键词: Adolescent; Anti-Retroviral Agents; BMS232632; Child; Childhood; Computer Retrieval of Information on Scientific Projects Database; Daily; Dose; Drug Formulations; Drug Kinetics; Funding; Grant; Infant; Institution; Label; Multicenter Studies; Phase; Powder dose form; Research; Research Personnel; Resources; Safety; Schedule; Source; Treatment Protocols; United States National Institutes of Health; capsule; novel

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. PACTG P1020-A is a phase I/II, open-label multicenter study of BMS-232632 as part of combination antiretroviral regimens. The availability of a powder formulation and once-daily dosing makes BMS-232632 an attractive agent for inclusion in pediatric regimens. The PACTG P1020-A study will determine the pharmacokinetic profile and dosing schedule of the capsule formulation for BMS-232632 in combination with two NRTIs, determine the pharmacokinetic profile and dosing schedule for the powder formulation in combination with two NRTIs, and determine the safety and tolerability of BMS-232632 in HIV-infected infants, children, and adolescents.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 PACTGP1020-A是作为联合抗逆转录病毒方案一部分的BMS-232632的I/II期开放标签多中心研究。BMS-232632的粉末配方和每日一次的剂量使其成为儿科治疗方案中具有吸引力的制剂。PACTG P1020-A研究将确定BMS-232632胶囊制剂与两种NRTI联合使用的药代动力学曲线和给药时间表，确定粉剂制剂与两种NRTI联合使用的药代动力学曲线和给药时间表，并确定BMS-232632在感染艾滋病毒的婴儿、儿童和青少年中的安全性和耐受性。