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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这是在该中心进行的第二阶段研究的延续（LA Biomed Project＃13028）。这项研究的目的是确定男性激素睾丸激素（也称为t-sterers）如何被人体代谢（分解）。这将通过给予性降压男性（男性缺乏雄性激素）并测量在设定的时间点中保留多少这些药物的T剂量来完成。这些新配方包含雄性激素睾丸激素的形式，睾丸激素（TE）或睾丸激素异酯（TU）与脂质（脂肪）化合物相结合。 TE已被用作治疗性降低男性的注射，已有50多年的历史，并且是美国的护理标准，但目前没有口服TE的口服准备。在欧洲，AISA和澳大利亚批准了口服TU和最近的TU注射剂，用于雄性激素的雄性激素替代疗法。目前，美国尚无口腔睾丸激素酯可用于美国的性低肿瘤男性。人们认为，本研究中使用的新配方将在几种方面优于当前可用的疗法。 所研究的TU制备与其他国家的TU销售不同，预计这种新的TU制剂可能会产生持续更长的血液睾丸激素水平。