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

本任务订单涉及工作说明书任务A、任务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茶碱（BE）的测定方法。承包商应使用经过验证的方法进行分析，以确定从可卡因和化合物TBD的1期单序列临床药代动力学药物相互作用研究中收集的血浆样品中的可卡因和BE的血浆浓度。这个任务单不包括TBD化合物的分析。临床研究将在住院医院进行。将采用平行组研究设计，涉及约30名健康志愿者。每位受试者将接受两种剂量的可卡因静脉输注在TBD化合物存在和不存在稳定血浆水平的情况下。在给予高剂量可卡因的同时，每位受试者将抽取13份血浆样本用于随后的可卡因和BE分析，每位受试者总共抽取26份血浆样本（本研究最多抽取780份血浆样本）。

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).