PHASE IIA, PILOT, PHARMACOKINETIC STUDY OF ORAL TESTOSTERONE ESTER FORMULATIO

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两种新的男性荷尔蒙睾酮(也称为T-酯)口服制剂(口服药物)是如何在人体内代谢的。这将通过给性腺功能低下的男性(男性激素缺乏的男性)服用不同剂量的这些T-酯来实现，并测量在设定的时间点这些药物在血液中的残留量。这些新配方含有雄性激素，以睾丸酮Enanthate(TE)或TU(TU)的形式与一种脂肪(脂肪)化合物结合。这些药物的脂肪部分使睾酮部分的吸收更容易和更有效，因为它主要被肠道吸收，而不是首先进入肝脏并被肝脏分解。 50多年来，TE一直被用作治疗性腺功能低下的男性的注射，在美国是治疗的标准。目前尚无TE的口服制剂。口服TU和最近TU注射已在欧洲、亚洲和澳大利亚被批准用于性腺功能低下男性的男性激素治疗。正在研究的TI制剂的配方与其他国家销售的TU不同。预计这一新的TU准备工作可能会持续更长时间。当注射或口服时，这些酯被分解为睾丸激素部分和酯部分。酯部分的代谢不会在体内产生任何作用(即不会引起副作用)。

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 two new oral formulations (medications to be taken by mouth) of male hormone Testosterone (also called T-esters) are metabolized by human body. This will be done by giving different doses of these T-esters to hypogonadal men (men deficient in male hormone) and measuring how much of these medications remains in the blood at set time points. These new formulations contain male hormone testosterone in the form of Testosterone Enanthate (TE) or Testosterone Undecanoate (TU) combined with a lipid (fatty) compound. The lipid part of these medications makes absorption of the testosterone portion easier and more efficient by being largely absorbed in the intestine instead of first going to and being broken down by the liver. TE has been used as an injection for the treatment of hypogonadal men for over 50 years and is the standard of care in the United States. There is no oral preparation of TE available. Oral TU and recently TU injections have been approved in Europe, Asia, and Australia for male hormone treatment of hypogonadal men. The TI preparation under study is formulated differently from the TU marketed in other countries. It is anticipated that this new TU preparation may last longer. These esters, when injected or taken by mouth, are broken down to testosterone portion and the ester portion. The ester portion is metabolized without any action in the body (i.e. cause no side effects).