FY20. ANALYTICAL SERVICES CENTER FOR MEDICATIONS DEVELOPMENT PROGRAM. TASK ORDER 3 -75N95020F00192. POP - 09.24.2020 TO 09.23.2022.

2020 财年。

• 批准号: 10285080
• 负责人: XIN ZHANG
• 金额: $ 13.13万
• 依托单位: XENOBIOTIC LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-25 至 2024-09-24
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10285080
• 关键词: Archives; Biological; Biological Assay; Clinical; Clinical Research; Cocaine; Contractor; Databases; Development; Dose; Drug Interactions; Drug Kinetics; Human; Inpatients; Intravenous infusion procedures; Liquid substance; Maintenance; Methods; Pharmaceutical Preparations; Phase; Plasma; Program Development; Records; Research Design; Sampling; Sampling Studies; Services; Validation; Work; benzoylecgonine; healthy volunteer

This Task Order involves work described in Task A, B, Task F, and Task G of the Statement of Work. The Contractor shall develop and validate assay(s) for the determination of cocaine and its metabolite, benzoylecgonine (BE) in human plasma. The Contractor shall conduct assays using a validated method(s) to determine plasma concentrations of cocaine and BE in plasma samples collected from a Phase 1, one-sequence clinical pharmacokinetic drug-drug interaction study of cocaine and a compound TBD. This task order does not include the analysis of the TBD compound. The clinical study will be carried out at an inpatient facility. A parallel group study design involving approximately 30 healthy volunteers will be used. Each subject will receive intravenous infusions of cocaine at two dose levels in the presence and absence of steady state plasma levels of the TBD compound. In conjunction with the administration of the high dose of cocaine, each subject will have 13 plasma samples drawn for subsequent cocaine and BE analysis, for a total of 26 plasma samples per subject (up to 780 plasma samples for the study).

此任务顺序涉及工作声明的任务A，B，任务F和任务G中描述的工作。承包商应开发和验证分析可卡因及其代谢物，苯甲烷基菌（BE）在人血浆中。承包商应使用经过验证的方法进行测定，以确定可卡因的血浆浓度，并在从1期1阶段的血浆样品中进行，即可卡因和化合物TBD的一阶临床临床药代动力学药物 - 药物 - 药物相互作用研究。此任务顺序不包括对TBD化合物的分析。临床研究将在住院设施进行。将使用涉及大约30名健康志愿者的平行组研究设计。在存在和不存在TBD化合物的稳态血浆水平的情况下，每个受试者将在两个剂量水平上接受可卡因的静脉输注。与高剂量可卡因的给药结合，每个受试者将绘制13个血浆样品，用于随后的可卡因并进行分析，每位受试者共有26个血浆样品（该研究最多780个血浆样品）。