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

本任务单涉及工作说明书任务A、B、任务F和任务G中描述的工作。承包商应开发并验证测定人血浆中可卡因及其代谢物苯甲酰ecGonine(BE)的分析方法(S)。承包商应使用有效的方法(S)进行分析，以确定可卡因和Be在血浆样本中的浓度，该样本来自可卡因和一种化合物待定的第一阶段临床药代动力学药物-药物相互作用研究。本任务单不包括待定化合物的分析。这项临床研究将在住院设施中进行。将采用平行分组研究设计，涉及大约30名健康志愿者。每个受试者将接受两个剂量水平的可卡因静脉输注，在存在和不存在稳态血浆水平待定化合物的情况下。在给予大剂量可卡因的同时，每个受试者将抽取13个血浆样本用于随后的可卡因和BE分析，每个受试者总共26个血浆样本(最多780个血浆样本用于研究)。

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).