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来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 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含有不同量的脂肪的食物对口服（口服）制剂的男性激素替诺明（也称为T-酯）的吸收的影响，所述制剂以替诺明十一酸酯（TU）的形式与脂质（脂肪）化合物组合。这将通过给予性腺功能减退男性（男性激素睾酮缺乏的男性）相同剂量的研究药物，同时改变饮食中的脂肪量来完成。 然后，将在不同时间点测量血液睾酮的量，以观察膳食脂肪的量是否影响血液中存在的睾酮的量（药代动力学研究）。 虽然TU在美国未被批准使用，但口服TU在欧洲、亚洲、南美洲、澳大利亚、墨西哥和加拿大已用于治疗性腺功能减退男性超过30年。目前，在美国没有可用于性腺功能减退男性的口服睾酮酯。 本研究将招募16名血液睾酮水平低的男性，约8名将在我们的研究中心完成研究。本研究将持续58天。将有2次门诊研究访视（以确定本研究的合格性）和5次住院，每次持续约28小时。正在服用睾酮的潜在受试者将在进入研究前1 - 4周停止睾酮治疗。他们应该没有其他的医疗问题。

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 Potential subjects who are taking testosterone will be withdrawn from testosterone treatment for 1 to 4 weeks prior to entering the study.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.