PHASE II STUDY OF THE EFFECT OF FOOD WITH VARIOUS LEVELS OF FAT ON THE PHARMACOK

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含有不同数量脂肪的食物对口服(口服)男性荷尔蒙睾酮(也称为T-酯)的吸收的影响，该制剂以十一酸睾酮(TU)和一种脂肪(脂肪)化合物的形式存在。这将通过给性腺功能低下的男性(男性荷尔蒙睾丸激素缺乏的男性)给予相同剂量的研究药物来实现，同时改变饮食中摄入的脂肪量。然后，将在不同的时间点测量血睾酮的量，以了解饮食脂肪的量是否影响血液中的睾丸素的量(药代动力学研究)。 尽管TU在美国没有被批准使用，但口服TU在欧洲、亚洲、南美、澳大利亚、墨西哥和加拿大用于治疗性腺功能低下的男性已有30多年的历史。目前，在美国，性腺功能低下的男性还没有口服睾丸素酯可用。 16名血睾酮水平较低的男性将被招募参加这项研究，大约8名将在我们的网站完成这项研究。这项研究将持续58天。将有2次门诊研究访问(以确定是否符合本研究的条件)和5次住院治疗，每次持续约28小时。正在服用睾丸素的潜在受试者将在进入研究之前停用1至4周的睾丸素治疗。他们应该不会有其他的健康问题。

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 the effect of food containing various amounts of fat on the absorption of oral (taken by mouth) formulation of the male hormone Testosterone (also called T-ester) in the form Testosterone Undecanoate (TU) combined with a lipid (fatty) compound. This will be done by giving the same dose of the study medication to hypogonadal men (men deficient in male hormone testosterone) while changing the amount of fat taken in the diet. Then, amounts of blood testosterone will be measured at different time points in order to see if the amount of dietary fat effects the amounts of testosterone present in blood (Pharmacokinetics study). Although TU is not approved for use in the United States, oral TU has available for treatment of hypogonadal men in Europe, Asia, South America, Australia, Mexico, and Canada for over 30 years. Currently, there are no oral testosterone esters available for hypogonadal men in the United States. 16 men with low levels of blood testosterone will be recruited for the study, and approximately 8 will complete the study at our site. This study will last up to 58 days. There will be 2 outpatient study visits (to determine eligibility for this study) and 5 inpatient hospital stays, each lasting about 28 hours. Potential subjects who are taking testosterone will be withdrawn from testosterone treatment for 1 to 4 weeks prior to entering the study. They should have no other medical problems.