CLINICAL TRIAL: A MULTIPLE DOSE, PHARMACOKINETIC STUDY

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究的目的是确定一种名为Nasobol的新型男性荷尔蒙睾丸素鼻腔内凝胶制剂是如何在人体内代谢的。这将通过给性腺功能低下的男性(男性荷尔蒙缺乏的男性)服用不同剂量的纳索博尔来实现，并测量在设定的时间点这些药物在血液中的残留量。这项研究将分为两组：性腺功能低下的男性接受研究性药物治疗，健康男性不接受研究性药物治疗。性腺功能低下的男性血液中的睾酮水平将与健康男性的水平进行比较。 健康男性的睾丸素水平遵循一种白天的模式，即睾丸激素在早上很高，然后逐渐下降，在傍晚时分降到最低水平。目前市场上的睾酮配方提供了不能模拟这种变化的恒定血清水平。Nasobol？是一种创新的睾丸素鼻腔给药药物配方，具有易于使用、可以模拟血清睾酮水平的每日变化、不会像应用在皮肤上的睾丸素那样转移到其他人身上的潜在优势。目前，在美国，没有可供性腺功能低下的男性使用的鼻腔内睾酮凝胶。

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.