INFLUENCE OF DRUG TRNSPRTR GENETICS ON ROSIGLITAZONE PHRMCOKINS IN HLTHY VOLNTRS

药物 TRNSPRTR 遗传学对 HLTHY VOLNTRS 中罗格列酮 PHRMCOKINS 的影响

• 批准号: 7604477
• 负责人: CHRISTINA L AQUILANTE
• 金额: $ 9.16万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604477
• 关键词: Affect; Blood; Blood specimen; Clinical Research; Collection; Computer Retrieval of Information on Scientific Projects Database; DNA; Diabetes Mellitus; Dose; Ensure; Funding; Genes; Genetic; Genetic Screening; Genotype; Grant; Hour; Institution; Laboratories; Liver; Methods; Mouthwash; Non-Insulin-Dependent Diabetes Mellitus; Oral; Persons; Pharmaceutical Preparations; Proteins; Purpose; Research; Research Personnel; Resources; Sampling; Source; Testing; Time; United States Food and Drug Administration; United States National Institutes of Health; Visit; Work; rosiglitazone

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. Rosiglitazone (Avandia¿) is approved by the Food and Drug Administration (FDA) and is used for the treatment of type 2 diabetes. People differ in the way they respond to rosiglitazone. It is an effective medication for some people, but it does not work as well in other people. This may be a result of differences in the amount of rosiglitazone in the blood. It also may be due to differences in the way that the drug is absorbed, broken-down, or transported in the body. The way a medication works in the body may be affected by a person's genetic make-up (or DNA). The purpose of this clinical study is to determine if a person's genetic make-up affects the amount of rosiglitazone in the blood. The genetic differences that will be studied are found in the OATP1B1 drug transporter gene. This protein is important for transporting many drugs, including rosiglitazone, into the liver. Although rosiglitazone is used to treat diabetes, we are studying the medication in healthy people. Subjects will be pre-screened for genetic differences in the OATP1B1 drug transporter gene. The pre-screening method for DNA collection will be a mouthwash sample. If a subject matches a needed genotype, they will be asked to return for further laboratory testing to ensure that they are healthy and can participate in the study. If the subject is healthy, they will be asked to participate in a 24-hour overnight study at the GCRC. During this 24-hour visit, subjects will receive a single, oral dose of rosiglitazone in the morning. Blood samples will be drawn at multiple time points over a 24-hour period to determine the amount of rosiglitazone in the blood. This study is an early step to see a person's genetic make-up affects the amount of rosiglitazone in the blood.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 罗格列酮（文迪雅）是由食品和药物管理局（FDA）批准，用于治疗2型糖尿病。 人们对罗格列酮的反应方式不同。 它对某些人来说是一种有效的药物，但对其他人来说效果并不好。 这可能是血液中罗格列酮含量差异的结果。 这也可能是由于药物在体内吸收，分解或运输方式的差异。 药物在体内的作用方式可能会受到一个人的基因组成（或DNA）的影响。 这项临床研究的目的是确定一个人的基因组成是否会影响血液中罗格列酮的含量。 将要研究的遗传差异存在于OATP 1B 1药物转运蛋白基因中。 这种蛋白质对于将包括罗格列酮在内的许多药物转运到肝脏中很重要。 虽然罗格列酮用于治疗糖尿病，但我们正在研究健康人的药物治疗。 将对受试者进行OATP 1B 1药物转运蛋白基因遗传差异的预筛选。 DNA采集的预筛选方法将是漱口水样本。 如果受试者与所需基因型匹配，将要求其返回接受进一步实验室检测，以确保其健康并可参与研究。 如果受试者健康，将要求他们参加GCRC的24小时过夜研究。 在24小时访视期间，受试者将在早晨接受罗格列酮单次口服给药。 将在24小时内的多个时间点采集血样，以测定血液中罗格列酮的含量。 这项研究是观察一个人的基因组成影响血液中罗格列酮含量的早期步骤。