CLINICAL TRIAL: A MULTIPLE DOSE, PHARMACOKINETIC STUDY

临床试验：多剂量药代动力学研究

• 批准号: 8174500
• 负责人: CHRISTINA C. WANG
• 金额: $ 1.84万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8174500
• 关键词: Blood; Circadian Rhythms; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Dose; Drug Formulations; Drug Kinetics; Funding; Gel; Grant; Hormones; Human body; Institution; Marketing; Measures; Nose; Pattern; Pharmaceutical Preparations; Pharmacologic Substance; Research; Research Personnel; Resources; Risk; Serum; Skin; Source; Testosterone; Time; United States; United States National Institutes of Health; Variant; innovation; male; men

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. The purpose of this study is to determine how a new intranasal (applied inside the nose) gel formulation of male hormone Testosterone called Nasobol¿ is metabolized by human body. This will be done by giving different doses of Nasobol¿ to hypogonadal men (men deficient in male hormone) and measuring how much of these medications remains in blood at set time points. This study will have two groups: hypogonadal men receiving study medication and healthy men not receiving study medication. Blood levels of testosterone in the hypogonadal men will be compared to those in the healthy men. Testosterone levels in healthy men follow a diurnal pattern in which testosterone is high in the morning and gradually declines reaching lowest levels in the early evening. Current marketed formulations of testosterone provide constant serum levels that do not mimic this variation. Nasobol¿ is an innovative pharmaceutical formulation of testosterone for nasal administration that has the potential advantages of ease of use, the possibility to mimic diurnal variation of serum testosterone levels, no risk of transfer to other people like in the testosterone applied on the skin. Currently, there is no available intranasal testosterone gel available for hypogonadal men in the United States.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以出现在其他 CRISP 条目中 列出的机构是。 对于中心来说，它不一定是研究者的机构。 这项研究的目的是确定一种新的鼻内（应用于鼻子内）雄性激素睾酮凝胶制剂（称为 Nasobol）如何发挥作用？这是通过给予不同剂量的 Nasobol 来完成的。这项研究将分为两组：接受研究药物的性腺功能减退男性和未接受研究药物的健康男性。性腺功能减退的男性将与健康男性进行比较。 健康男性的睾酮水平遵循昼夜模式，其中睾酮在早晨较高，并在傍晚逐渐下降至最低水平，目前市售的睾酮配方提供了恒定的血清水平，但与 Nasobol 不同。是一种用于鼻腔给药的创新睾酮药物制剂，具有易于使用的潜在优点，可以模拟血清睾酮水平的昼夜变化，并且没有像目前应用于皮肤的睾酮那样转移给其他人的风险。在美国，尚无适用于性腺功能减退男性的鼻内睾酮凝胶。