CLINICAL TRIAL: A MULTIPLE DOSE, PHARMACOKINETIC STUDY

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来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 研究中心，而研究中心不一定是研究者所在的机构。 本研究的目的是确定一种新的鼻内（应用于鼻内）凝胶制剂的男性激素Texol称为Nasobol？是如何被人体代谢的。这将通过给予性腺功能减退的男性（男性激素缺乏的男性）不同剂量的Nasobol来完成，并测量在设定的时间点这些药物在血液中的残留量。 本研究将分为两组：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。将性腺功能减退男性的血液睾酮水平与健康男性的血液睾酮水平进行比较。 健康男性的睾酮水平遵循昼夜模式，其中睾酮在早晨较高，并逐渐下降，在傍晚达到最低水平。目前市售的睾酮制剂提供不模拟这种变化的恒定血清水平。纳索博尔是一种创新的药物制剂的睾酮鼻腔给药，具有潜在的优势，易于使用，可能模仿昼夜变化的血清睾酮水平，没有风险转移到其他人一样，在睾酮应用于皮肤上。目前，在美国没有可用于性腺功能减退男性的鼻内睾酮凝胶。

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.