CLINICAL TRIAL: PHASE IIA, REPEAT DOSE, PHARMACOKINETIC STUDY OF ORAL TESTOSTERO

临床试验：IIA 期、重复剂量、口服睾酮的药代动力学研究

• 批准号: 7952270
• 负责人: RONALD Sherwin SWERDLOFF
• 金额: $ 27.64万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952270
• 关键词: Australia; Blood; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Country; Dose; Drug Formulations; Drug Kinetics; Esters; Europe; Funding; Grant; Hormone replacement therapy; Hormones; Human body; Injection of therapeutic agent; Institution; Lipids; Marketing; Measures; Oral; Oral cavity; Pharmaceutical Preparations; Phase; Phase II Clinical Trials; Preparation; Research; Research Personnel; Resources; Source; Testosterone; Testosterone Enanthate; Time; United States; United States National Institutes of Health; male; men; oral form testosterone; standard of care

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. This is a continuation of a phase 2 study that was done at this center (LA Biomed project # 13028). 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 (broken down) by human body. This will be done by giving different doses of T-esters to hypogonadal men (men deficient in male hormone) and measuring how much of these medications remain 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. 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, but there is no oral preparation of TE currently available. Oral TU and recently TU injections are approved in Europe, Aisa, and Australia for male hormone replacement therapy in hypogonadal men. Currently, there are no oral testosterone esters available for hypogonadal men in the United States. It is believed that the new formulations that are being used in this study will be superior to the currently available therapies in several ways. The TU preparation under study is formulated differently from the TU marketed in other countries and it is anticipated that this new TU preparation may produce blood testosterone levels that last longer.

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。 这是在该中心进行的第二阶段研究(洛杉矶生物工程#13028)的继续。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)的口服制剂(口服药物)如何在人体内代谢(分解)。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。 50多年来，TE一直被用作注射治疗性腺功能减退的男性，在美国是治疗的标准，但目前还没有TE的口服制剂。口服TU和最近TU注射在欧洲、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替代治疗。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。据信，这项研究中使用的新配方将在几个方面优于目前可用的疗法。 正在研究的TU制剂的配方与其他国家销售的TU不同，预计这种新的TU制剂可能会产生更长时间的血睾酮水平。